© 2015 Wiley Periodicals, Inc.
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Sutureless Aortic Valve Replacement for Aortic Incompetence Daniyar Sh. Gilmanov, Marco Solinas, Enkel Kallushi, Tommaso Gasbarri, Giacomo Bianchi, Pier Andrea Farneti, and Mattia Glauber Adult Cardiac Surgery Department, G. Monasterio Tuscany Foundation – G. Pasquinucci Heart Hospital, Massa, Italy ABSTRACT Objective: Sutureless prostheses for surgical aortic valve replacement (AVR) are usually used in degenerative calcified aortic stenosis. Less is known on the application of sutureless prostheses for pure aortic incompetence. Methods: Between 2011 and 2014, 442 patients were operated on with the Perceval aortic sutureless valve implant. We identified 11 patients (10 female, mean age 70.5) who underwent sutureless AVR for pure aortic incompetence (off-label use). Three patients had a left ventricle ejection fraction of 30% or less. Mean logistic EuroSCORE was 15.2 (range 2.2–45.2). In five patients associated mitral procedures (three [60%] repair and two [40%] replacement) were performed. Four procedures were performed through a minimally invasive approach (three right minithoracotomies and one partial sternotomy). Results: Mean cardiopulmonary bypass time was 130.2 min and aortic cross clamp time was 82.2 min. Mean implanted prosthesis size was 24.5 W 1.3 (median 25) mm (insignificant correlation with preoperative aortic valve annulus measurement by transthoracic echocardiography: 21.6 W 1.5 [median 21] mm, Pearsons r = 0.373, p = 0.259). One patient died on 24th day after AVR associated with aortic arch replacement and hypothermic circulatory arrest (10 years after correction for type A aortic dissection). No residual para- or intravalvular leakage was present on discharge and 12-month follow-up. No migration of the prosthesis occurred. Conclusion: Sutureless AVR is an option in selected patients with aortic incompetence. Preoperative aortic annulus measurement by echocardiography has poor predictive value for estimation of prosthetic valve size. doi: 10.1111/jocs.12531 (J Card Surg 2015;30:391–395) Sutureless prostheses for surgical aortic valve replacement (AVR) are usually used in degenerative calcified aortic stenosis cases and are associated with reduced operative times. Less is known on the application of sutureless prostheses for pure aortic incompetence. Herein we analyze our experience with Perceval (Sorin Biomedica Cardio Srl, Saluggia, Italy) sutureless AVR for patients with aortic incompetence (off-label use). The Perceval sutureless valve is a new self-expandable prosthesis made of bovine pericardium mounted in a Nitinol stent, designed as an alternative to the traditional prostheses to simplify surgical implantation. Recently, the Perceval has shown excellent results in terms of postoperative outcomes and hemodynamic performance, decreasing the operative times.1–3
Conflict of interest: Dr. Glauber M. and Dr. Solinas M. have to disclose a commercial/financial relationship with Sorin Group. No funding received during the manuscript preparation. Address for correspondence: Gilmanov Daniyar, Fellow in Cardiac Surgery, Gabriele Monasterio Foundation, G. Pasquinucci Heart Hospital, 305, Via Aurelia Sud, loc. Montepepe, Massa, MS 54100, Italy. Fax: 0039 0585 493614; e-mail: [email protected]
METHODS Written informed consent of the patients was waived and approval of the ethical committee of the G. Pasquinucci Heart Hospital (FTGM, Tuscany) was obtained. All cases have been discussed at the Heartteam conference with cardiologists and cardiothoracic surgeons in attendance. Aortic root pathology (dilated, asymmetric root) was considered an exclusion criterion for the sutureless valve prosthesis implant. Definitions Tobacco smoke exposure (irrespective actual or past) indicated smoker status. Dyslipidemia was defined as high values of either total cholesterol (>200 mg/dL), or low-density lipoproteins cholesterol (>150 mg/dL), or low values of high-density lipoproteins cholesterol (50% internal diameter reduction) or aneurysmal lesion in the peripheral vascular tree, including the aorta, while cerebrovascular disease includes only those of carotid or vertebral arterial bed. Duke criteria were applied for endocarditis. Respiratory function tests with measurement of forced expiratory volume in one second (FEV1) and vital capacity (VC) documented chronic obstructive pulmonary disease (COPD). All patients with daily need for bronchodilators, or chronic cough more than three months per year, over three consecutive years, and documented FEV1/VC less than 80% of the reference value, were considered as having COPD. Left ventricular function and aortic regurgitation severity was evaluated by echocardiography. Hospital mortality included all deaths within 30 days of operation irrespective of where the death occurred and all deaths in hospital after 30 days among patients who had not been discharged after the index operation. New onset atrial fibrillation (AF) was defined by the documentation of AF of any duration at any point in the postoperative period on a rhythm strip or 12-lead electrocardiogram. Neurological complications included permanent (with duration more than 72 hours, or strokes) and transient (transient ischemic attacks or reversible cerebrovascular accidents) neurological events. Postoperative stroke (permanent cerebrovascular accident, CVA) was defined as any new permanent major (type II) neurologic deficit that occurs anytime during the postoperative hospitalization and/ or new findings on computed tomography (CT) or magnetic resonance imaging (MRI), persisting for more than 72 hours. This was a retrospective, observational study of prospectively collected data from 442 consecutive patients with aortic valve disease operated on with Perceval aortic sutureless valve implant between March 2011 and April 2014 at G. Pasquinucci Heart Hospital. We identified 11 (2.49%) patients (10 [91%] female, mean age 70.5) who underwent sutureless AVR for pure or predominant aortic incompetence (off-label use). The decision whether to implant the sutureless prosthesis or the conventional one was made for technical reasons or to reduce ischemic time in an ill patient. Baseline clinical data of the patients are presented in Table 1. Three (27.3%) patients had left ventricle ejection fraction 30% or less. There were three (27.3%) reoperative cases and two (18.2%) of them with active infective endocarditis. One (9.1%) patient had a bicuspid aortic valve, and it was altered by infective endocarditis. Mean logistic EuroSCORE was 15.2 (median 7.62, range 2.2–45.2, 25th–75th percentiles, interquartile range [IQR]: 5.76–23.92). In five (45.5%) patients there was an associated mitral procedure (three [60%] mitral repairs and two [40%] replacement) and in one patient (9.1%) coronary artery bypass grafting was performed. In one patient aortic arch replacement was performed under hypothermic circulatory arrest. Four (36.4%) surgeries were performed through a minimally invasive approach (three right minithoracotomies and one partial sternotomy). Isolated
J CARD SURG 2015;30:391–395
AVR was performed in four patients operated through median sternotomy (one redo patient with aortic valve prosthetic infective endocarditis), right anterior minithoracotomy (two patients), and partial upper ministernotomy (one patient). Sutureless aortic valve prosthesis was implanted according to the manufacturer specifications, in a usual manner, which has been described elsewhere.4,5 Postoperative echocardiograms were performed at six-month intervals, and so far, ten, seven, and four patients reached six, 12 and 18 months of follow-up, respectively. RESULTS Mean cardiopulmonary bypass time was 130.2 54 min and aortic cross clamp time was 82.2 32.3 min (94.0 15.7 and 52.3 18.8 min for isolated AVR procedures, respectively). Nine patients received 25 mm prosthesis, and one patient received 21 mm and 23 mm prosthesis each. Mean implanted prosthesis size was 24.5 1.3 (median 25, IQR [25–25]) mm (insignificant correlation with preoperative aortic valve annulus measurement by transthoracic echocardiography: 21.6 1.5 (median 21, IQR [20–23]) mm, Pearson’s r ¼ 0.373, p ¼ 0.259; Kendall’s tau b ¼ 0.308, p ¼ 0.275; Spearman’s rho ¼ 0.328, p ¼ 0.324) (Fig. 1). In all patients implant success was achieved (11/11, 100%). Early postoperative outcomes of the patients are shown in the Table 2. One (9.1%) patient was re-explored due to early postoperative bleeding, and the underlying cause was an arterial vessel of the thoracic wall. One (9.1%) patient died following an irreversible stroke on 24th day after AVR associated with aortic arch replacement and hypothermic circulatory arrest (10 years after correction for type A acute aortic dissection). Ten patients were discharged from the hospital with a normally functioning aortic valve prosthesis. As of today, seven patients were followed up to one year. No death and no recurrence or new onset of infective endocarditis occurred during follow-up. No residual para- or intravalvular leakage was present on discharge and median 14.2 (mean 13.7 6.2) months (range 5–23) follow-up. No patient was implanted with a permanent pacemaker following the index operation. No migration/dislocation of the prosthesis occurred. DISCUSSION In previous clinical studies with the Perceval sutureless prosthesis infective endocarditis was an exclusion criterion for sutureless AVR.1,2,4 Our data demonstrate technical feasibility of sutureless AVR in this clinical setting, though long-term follow-up data are not available. Even though there was no specific intention to recruit women, an important proportion of patients were female (91%), which probably influenced a higher risk profile by EuroSCORE and STS score. This fact distinguishes the current study from the previous ones
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TABLE 1 Baseline Preoperative Data Variable
Proportion or Mean W Standard Deviation
Female gender Age, years Height, cm Weight, kg Body mass index, kg/sq m Smoker Hypercholesterolemia Diabetes mellitus Family history of cardiovascular disease Arterial hypertension Mild to moderate chronic renal failure Preoperative serum creatinine, mg/dL Extracardiac peripheral arteriopathy Cerebrovascular disease Active endocarditis Chronic obstructive pulmonary disease Redo Concomitant mitral regurgitation and mitral surgery Heart failure by NYHA III–IV Left ventricular ejection fraction, % Aortic valve lesion Severe regurgitation Moderate-to-severe regurgitation EuroSCORE additive model EuroSCORE logistic model STS score Surgery priority/urgency
10 (91%) 70.5 9.8 162.4 6.0 64.0 13.5 24.2 4.5 2 (18%) 5 (45%) 1 (9%) 2 (18%) 5 (45%) 3 (27%) 0.99 0.38 2 (18%) 1 (9%) 2 (18%) 2 (18%) 3 (27%)a 5 (45%) 6 (55%) 48.2 12.3 9 (82%) 2 (18%)b 8.3 3.3 15.2 14.9 8.9 6.0 5 (45%)
Median (IQR)
70.4 (62.5–78.2) 160 (158–168) 61 (59–65) 23.4 (21.5–25.9)
0.92 (0.63–1.28)
50 (40–55)
7.00 (6.00–11.00) 7.62 (5.76–23.92) 5.2 (1.2–19.0)
EuroSCORE – European System for cardiac operative risk evaluation; IQR – interquartile range (25th-75th percentile); NYHA – New York Heart Association; STS – Society of Thoracic Surgeons. a One patient with prior acute A type aortic dissection, repaired aortic valve, and replaced ascending aorta/hemiarch; one patient with previous aortic valve repair, single CABG, atrial fibrillation radiofrequency ablation, and mitral valve replacement; one patient with previous aortic valve repair and ascending aorta replacement. b One patient with combined lesion and predominant regurgitation.
that describe the use of the Perceval sutureless prosthesis.1,2,6 Cardiopulmonary bypass times for isolated sutureless AVR are in line with our previous data,5 and have
been slightly reduced with continuously growing experience. A rapidly implantable aortic valve prostheses may reduce the patient’s exposure to cardiopulmonary bypass and may be particularly indicated in
Figure 1. Single case per case comparison between annulus diameter by transthoracic echocardiography and sutureless aortic valve prosthesis size received during surgery. The longer the line, the more important the discrepancy between the two parameters. Note that transthoracic echocardiogram usually underestimates the real diameter of the prosthesis size.
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TABLE 2 Early Outcomes of the Patients Variable
Median (IQR)
Revision for bleeding Mortality Stroke Transient ischemic attack New onset atrial fibrillation Complete atrioventricular block treated with permanent pacemaker implant Assisted mechanical ventilation, h; range ICU length of stay, days; mean standard deviation; range Hospital length of stay, days; mean standard deviation; range
1 (9%) 1 (9%)a 2 (18%)a 1 (9%) 4 (36%) 0 3–580 4.82 8.33; 1–24 10 6.25; 5–24
10 (6–13) 1 (1–2) 7 (6–14)
ICU, intensive care unit; IQR, interquartile range. a One patient with redo aortic arch replacement.
complex clinical cases, at high surgical risk and with associated procedures. However, several anatomical and clinical circumstances, for example, aortic root pathology, such as a Valsalva sinus dilation, annuloaortic ectasia, asymmetric, or bicuspid aortic valve, mechanical characteristics of aortic annulus associated with elastin deficiency or collagen diseases, are considered indications for sutured aortic valve replacement or root replacement, and may restrict the use of sutureless prostheses. In contrast to calcific aortic stenosis, the aortic annulus in aortic regurgitation is usually elastic, and may explain the low incidence of postoperative pacemaker implantation observed in our study. A series of reports on transcatheter aortic valve replacement in patients with pure aortic regurgitation with off-label indication has been published, as a bailout procedure.7–10 Considering the common sutureless concept, surgical AVR with a Perceval prosthesis fits well with such an indication. Notably, in the largest registry study by Roy et al.,9 up to 18.6% of patients necessitated a second transcatheter prosthesis implant due to residual regurgitation. No patient in the present study experienced prosthesis repositioning or other technical problems associated with prosthesis delivery. There is increasing evidence that for transcatheter sutureless prostheses preoperative echocardiographic measurement of the aortic annulus has inferior predictive value for prosthesis size compared with CT scan.11–13 Three dimensional reconstruction of the aortic root is better adapted to transform three-lobe circumference (native aortic annulus) into the diameter of a regular circular structure (aortic valve prosthesis). Further, it allows to account for elliptical conformation of the aortic annulus and the presence of eventual rough calcifications, that may distort it. Our echocardiographic data did not correlate well with the implanted prosthesis size, and future studies could address the precision and accuracy of CT predicted sutureless prosthesis size in patients with aortic regurgitation as the primary pathology. Theoretically, given the removal of diseased cusps, CT scan for surgical sutureless prostheses might demonstrate even better correlation with native aortic annulus diameter compared with transcatheter prostheses. Interestingly, in the present case series preoperative
echocardiographic evaluation of the native aortic annulus underestimated the prosthesis size (Fig. 1). Aortic valve pathology may play a role in this discrepancy; a regurgitant aortic valve without severe root/ annulus calcification retains elastic properties of the annulus (capacity to receive a greater prosthesis), while degenerative aortic stenosis renders the aortic root complex stiff and rigid. Experimental studies have demonstrated cyclic changes in the geometry of the aortic root, in particular, systolic expansion,14–16 and physiological dynamics of aortic root complex may be supported by the Perceval sutureless prosthesis, which features elastic Nitinol structure. Stented aortic prostheses are lacking annular distensibility, and may impede physiologic aortic root expansion after AVR. Substantial aortic root dilation occurs before the native cusps begin to open, which alone is thought to contribute 20% of cusp opening,17 thus sutureless valves may contribute to lower gradients and patient-prosthesis mismatch incidence. There are several limitations to our study. As a retrospective study without a control group, there may be biases that could confound our findings, which were not adjusted for. Small sample size and extremely heterogeneous study population may account for skewness of continuous data and abnormal distribution of dichotomous ones. The follow-up period was relatively short. REFERENCES 1. Folliguet TA, Laborde F, Zannis K, et al: Sutureless Perceval aortic valve replacement: Results of two European centers. Ann Thorac Surg 2012;93:1483–1488. 2. Miceli A, Santarpino G, Pfeiffer S, et al: Minimally invasive aortic valve replacement with Perceval S sutureless valve: Early outcomes and one-year survival from two European centers. J Thorac Cardiovasc Surg. 2014;148:2838–43. 3. Gilmanov D, Miceli A, Ferrarini M, et al.: Aortic valve replacement through right anterior minithoracotomy: Can sutureless technology improve clinical outcomes. Ann Thorac Surg 2014;98:1585–1592. 4. Santarpino G, Pfeiffer S, Schmidt J, et al: Sutureless aortic valve replacement: First-year single-center experience. Ann Thorac Surg 2012;94:504–509. 5. Gilmanov D, Miceli A, Bevilacqua S, et al: Sutureless implantation of the Perceval S aortic valve prosthesis
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11.
through right anterior minithoracotomy. Ann Thorac Surg 2013;96:2101–2108. Rubino AS, Santarpino G, De Praetere H, et al: Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: Results of a multicenter study. J Thorac Cardiovasc Surg 2014;148:865–871. Sarkar K, Sardella G, Romeo F, et al: Transcatheter aortic valve implantation for severe regurgitation in native and degenerated bioprosthetic aortic valves. Catheter Cardiovasc Interv 2013;81:864–870. Segev A, Spiegelstein D, Fefer P, et al: Transcatheter aortic valve implantation for non-classical indications. Isr Med Assoc J 2013;15:399–403. Roy DA, Schaefer U, Guetta V, et al: Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol 2013;61:1577–1584. Chiam PT, Ewe SH, Chua YL, et al: First transcatheter aortic valve implantation for severe pure aortic regurgitation in Asia. Singapore Med J 2014;55:103–105. Watanabe Y, Morice MC, Bouvier E, et al: Automated 3dimensional aortic annular assessment by multidetector
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computed tomography in transcatheter aortic valve implantation. JACC Cardiovasc Interv 2013;6:955–964. Azzalini L, Sharma UC, Ghoshhajra BB, et al: Feasibility of C-arm computed tomography for transcatheter aortic valve replacement planning. J Cardiovasc Comput Tomogr 2014;8:33–43. Schuhbaeck A, Achenbach S, Pflederer T, et al: Reproducibility of aortic annulus measurements by computed tomography. Eur Radiol. 2014;24:1878–88. Lansac E, Lim HS, Shomura Y, et al: A four-dimensional study of the aortic root dynamics. Eur J Cardiothorac Surg 2002;22:497–503. Lansac E, Lim HS, Shomura Y, et al: Aortic root dynamics are asymmetric. J Heart Valve Dis 2005;14: 400–407. Dagum P, Green GR, Nistal FJ, et al: Deformational dynamics of the aortic root: Modes and physiologic determinants. Circulation (suppl) 1999; p. 100 I: II54– II562. Gnyaneshwar R, Kumar RK, Balakrishnan KR. Dynamic analysis of the aortic valve using a finite element model. Ann Thorac Surg 2002;73:1122–1129.
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ORIGINAL ARTICLE _____________________________________________________________
Sutureless Aortic Valve Replacement for Aortic Incompetence Daniyar Sh. Gilmanov, Marco Solinas, Enkel Kallushi, Tommaso Gasbarri, Giacomo Bianchi, Pier Andrea Farneti, and Mattia Glauber Adult Cardiac Surgery Department, G. Monasterio Tuscany Foundation – G. Pasquinucci Heart Hospital, Massa, Italy ABSTRACT Objective: Sutureless prostheses for surgical aortic valve replacement (AVR) are usually used in degenerative calcified aortic stenosis. Less is known on the application of sutureless prostheses for pure aortic incompetence. Methods: Between 2011 and 2014, 442 patients were operated on with the Perceval aortic sutureless valve implant. We identified 11 patients (10 female, mean age 70.5) who underwent sutureless AVR for pure aortic incompetence (off-label use). Three patients had a left ventricle ejection fraction of 30% or less. Mean logistic EuroSCORE was 15.2 (range 2.2–45.2). In five patients associated mitral procedures (three [60%] repair and two [40%] replacement) were performed. Four procedures were performed through a minimally invasive approach (three right minithoracotomies and one partial sternotomy). Results: Mean cardiopulmonary bypass time was 130.2 min and aortic cross clamp time was 82.2 min. Mean implanted prosthesis size was 24.5 W 1.3 (median 25) mm (insignificant correlation with preoperative aortic valve annulus measurement by transthoracic echocardiography: 21.6 W 1.5 [median 21] mm, Pearsons r = 0.373, p = 0.259). One patient died on 24th day after AVR associated with aortic arch replacement and hypothermic circulatory arrest (10 years after correction for type A aortic dissection). No residual para- or intravalvular leakage was present on discharge and 12-month follow-up. No migration of the prosthesis occurred. Conclusion: Sutureless AVR is an option in selected patients with aortic incompetence. Preoperative aortic annulus measurement by echocardiography has poor predictive value for estimation of prosthetic valve size. doi: 10.1111/jocs.12531 (J Card Surg 2015;30:391–395) Sutureless prostheses for surgical aortic valve replacement (AVR) are usually used in degenerative calcified aortic stenosis cases and are associated with reduced operative times. Less is known on the application of sutureless prostheses for pure aortic incompetence. Herein we analyze our experience with Perceval (Sorin Biomedica Cardio Srl, Saluggia, Italy) sutureless AVR for patients with aortic incompetence (off-label use). The Perceval sutureless valve is a new self-expandable prosthesis made of bovine pericardium mounted in a Nitinol stent, designed as an alternative to the traditional prostheses to simplify surgical implantation. Recently, the Perceval has shown excellent results in terms of postoperative outcomes and hemodynamic performance, decreasing the operative times.1–3
Conflict of interest: Dr. Glauber M. and Dr. Solinas M. have to disclose a commercial/financial relationship with Sorin Group. No funding received during the manuscript preparation. Address for correspondence: Gilmanov Daniyar, Fellow in Cardiac Surgery, Gabriele Monasterio Foundation, G. Pasquinucci Heart Hospital, 305, Via Aurelia Sud, loc. Montepepe, Massa, MS 54100, Italy. Fax: 0039 0585 493614; e-mail: [email protected]
METHODS Written informed consent of the patients was waived and approval of the ethical committee of the G. Pasquinucci Heart Hospital (FTGM, Tuscany) was obtained. All cases have been discussed at the Heartteam conference with cardiologists and cardiothoracic surgeons in attendance. Aortic root pathology (dilated, asymmetric root) was considered an exclusion criterion for the sutureless valve prosthesis implant. Definitions Tobacco smoke exposure (irrespective actual or past) indicated smoker status. Dyslipidemia was defined as high values of either total cholesterol (>200 mg/dL), or low-density lipoproteins cholesterol (>150 mg/dL), or low values of high-density lipoproteins cholesterol (50% internal diameter reduction) or aneurysmal lesion in the peripheral vascular tree, including the aorta, while cerebrovascular disease includes only those of carotid or vertebral arterial bed. Duke criteria were applied for endocarditis. Respiratory function tests with measurement of forced expiratory volume in one second (FEV1) and vital capacity (VC) documented chronic obstructive pulmonary disease (COPD). All patients with daily need for bronchodilators, or chronic cough more than three months per year, over three consecutive years, and documented FEV1/VC less than 80% of the reference value, were considered as having COPD. Left ventricular function and aortic regurgitation severity was evaluated by echocardiography. Hospital mortality included all deaths within 30 days of operation irrespective of where the death occurred and all deaths in hospital after 30 days among patients who had not been discharged after the index operation. New onset atrial fibrillation (AF) was defined by the documentation of AF of any duration at any point in the postoperative period on a rhythm strip or 12-lead electrocardiogram. Neurological complications included permanent (with duration more than 72 hours, or strokes) and transient (transient ischemic attacks or reversible cerebrovascular accidents) neurological events. Postoperative stroke (permanent cerebrovascular accident, CVA) was defined as any new permanent major (type II) neurologic deficit that occurs anytime during the postoperative hospitalization and/ or new findings on computed tomography (CT) or magnetic resonance imaging (MRI), persisting for more than 72 hours. This was a retrospective, observational study of prospectively collected data from 442 consecutive patients with aortic valve disease operated on with Perceval aortic sutureless valve implant between March 2011 and April 2014 at G. Pasquinucci Heart Hospital. We identified 11 (2.49%) patients (10 [91%] female, mean age 70.5) who underwent sutureless AVR for pure or predominant aortic incompetence (off-label use). The decision whether to implant the sutureless prosthesis or the conventional one was made for technical reasons or to reduce ischemic time in an ill patient. Baseline clinical data of the patients are presented in Table 1. Three (27.3%) patients had left ventricle ejection fraction 30% or less. There were three (27.3%) reoperative cases and two (18.2%) of them with active infective endocarditis. One (9.1%) patient had a bicuspid aortic valve, and it was altered by infective endocarditis. Mean logistic EuroSCORE was 15.2 (median 7.62, range 2.2–45.2, 25th–75th percentiles, interquartile range [IQR]: 5.76–23.92). In five (45.5%) patients there was an associated mitral procedure (three [60%] mitral repairs and two [40%] replacement) and in one patient (9.1%) coronary artery bypass grafting was performed. In one patient aortic arch replacement was performed under hypothermic circulatory arrest. Four (36.4%) surgeries were performed through a minimally invasive approach (three right minithoracotomies and one partial sternotomy). Isolated
J CARD SURG 2015;30:391–395
AVR was performed in four patients operated through median sternotomy (one redo patient with aortic valve prosthetic infective endocarditis), right anterior minithoracotomy (two patients), and partial upper ministernotomy (one patient). Sutureless aortic valve prosthesis was implanted according to the manufacturer specifications, in a usual manner, which has been described elsewhere.4,5 Postoperative echocardiograms were performed at six-month intervals, and so far, ten, seven, and four patients reached six, 12 and 18 months of follow-up, respectively. RESULTS Mean cardiopulmonary bypass time was 130.2 54 min and aortic cross clamp time was 82.2 32.3 min (94.0 15.7 and 52.3 18.8 min for isolated AVR procedures, respectively). Nine patients received 25 mm prosthesis, and one patient received 21 mm and 23 mm prosthesis each. Mean implanted prosthesis size was 24.5 1.3 (median 25, IQR [25–25]) mm (insignificant correlation with preoperative aortic valve annulus measurement by transthoracic echocardiography: 21.6 1.5 (median 21, IQR [20–23]) mm, Pearson’s r ¼ 0.373, p ¼ 0.259; Kendall’s tau b ¼ 0.308, p ¼ 0.275; Spearman’s rho ¼ 0.328, p ¼ 0.324) (Fig. 1). In all patients implant success was achieved (11/11, 100%). Early postoperative outcomes of the patients are shown in the Table 2. One (9.1%) patient was re-explored due to early postoperative bleeding, and the underlying cause was an arterial vessel of the thoracic wall. One (9.1%) patient died following an irreversible stroke on 24th day after AVR associated with aortic arch replacement and hypothermic circulatory arrest (10 years after correction for type A acute aortic dissection). Ten patients were discharged from the hospital with a normally functioning aortic valve prosthesis. As of today, seven patients were followed up to one year. No death and no recurrence or new onset of infective endocarditis occurred during follow-up. No residual para- or intravalvular leakage was present on discharge and median 14.2 (mean 13.7 6.2) months (range 5–23) follow-up. No patient was implanted with a permanent pacemaker following the index operation. No migration/dislocation of the prosthesis occurred. DISCUSSION In previous clinical studies with the Perceval sutureless prosthesis infective endocarditis was an exclusion criterion for sutureless AVR.1,2,4 Our data demonstrate technical feasibility of sutureless AVR in this clinical setting, though long-term follow-up data are not available. Even though there was no specific intention to recruit women, an important proportion of patients were female (91%), which probably influenced a higher risk profile by EuroSCORE and STS score. This fact distinguishes the current study from the previous ones
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TABLE 1 Baseline Preoperative Data Variable
Proportion or Mean W Standard Deviation
Female gender Age, years Height, cm Weight, kg Body mass index, kg/sq m Smoker Hypercholesterolemia Diabetes mellitus Family history of cardiovascular disease Arterial hypertension Mild to moderate chronic renal failure Preoperative serum creatinine, mg/dL Extracardiac peripheral arteriopathy Cerebrovascular disease Active endocarditis Chronic obstructive pulmonary disease Redo Concomitant mitral regurgitation and mitral surgery Heart failure by NYHA III–IV Left ventricular ejection fraction, % Aortic valve lesion Severe regurgitation Moderate-to-severe regurgitation EuroSCORE additive model EuroSCORE logistic model STS score Surgery priority/urgency
10 (91%) 70.5 9.8 162.4 6.0 64.0 13.5 24.2 4.5 2 (18%) 5 (45%) 1 (9%) 2 (18%) 5 (45%) 3 (27%) 0.99 0.38 2 (18%) 1 (9%) 2 (18%) 2 (18%) 3 (27%)a 5 (45%) 6 (55%) 48.2 12.3 9 (82%) 2 (18%)b 8.3 3.3 15.2 14.9 8.9 6.0 5 (45%)
Median (IQR)
70.4 (62.5–78.2) 160 (158–168) 61 (59–65) 23.4 (21.5–25.9)
0.92 (0.63–1.28)
50 (40–55)
7.00 (6.00–11.00) 7.62 (5.76–23.92) 5.2 (1.2–19.0)
EuroSCORE – European System for cardiac operative risk evaluation; IQR – interquartile range (25th-75th percentile); NYHA – New York Heart Association; STS – Society of Thoracic Surgeons. a One patient with prior acute A type aortic dissection, repaired aortic valve, and replaced ascending aorta/hemiarch; one patient with previous aortic valve repair, single CABG, atrial fibrillation radiofrequency ablation, and mitral valve replacement; one patient with previous aortic valve repair and ascending aorta replacement. b One patient with combined lesion and predominant regurgitation.
that describe the use of the Perceval sutureless prosthesis.1,2,6 Cardiopulmonary bypass times for isolated sutureless AVR are in line with our previous data,5 and have
been slightly reduced with continuously growing experience. A rapidly implantable aortic valve prostheses may reduce the patient’s exposure to cardiopulmonary bypass and may be particularly indicated in
Figure 1. Single case per case comparison between annulus diameter by transthoracic echocardiography and sutureless aortic valve prosthesis size received during surgery. The longer the line, the more important the discrepancy between the two parameters. Note that transthoracic echocardiogram usually underestimates the real diameter of the prosthesis size.
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TABLE 2 Early Outcomes of the Patients Variable
Median (IQR)
Revision for bleeding Mortality Stroke Transient ischemic attack New onset atrial fibrillation Complete atrioventricular block treated with permanent pacemaker implant Assisted mechanical ventilation, h; range ICU length of stay, days; mean standard deviation; range Hospital length of stay, days; mean standard deviation; range
1 (9%) 1 (9%)a 2 (18%)a 1 (9%) 4 (36%) 0 3–580 4.82 8.33; 1–24 10 6.25; 5–24
10 (6–13) 1 (1–2) 7 (6–14)
ICU, intensive care unit; IQR, interquartile range. a One patient with redo aortic arch replacement.
complex clinical cases, at high surgical risk and with associated procedures. However, several anatomical and clinical circumstances, for example, aortic root pathology, such as a Valsalva sinus dilation, annuloaortic ectasia, asymmetric, or bicuspid aortic valve, mechanical characteristics of aortic annulus associated with elastin deficiency or collagen diseases, are considered indications for sutured aortic valve replacement or root replacement, and may restrict the use of sutureless prostheses. In contrast to calcific aortic stenosis, the aortic annulus in aortic regurgitation is usually elastic, and may explain the low incidence of postoperative pacemaker implantation observed in our study. A series of reports on transcatheter aortic valve replacement in patients with pure aortic regurgitation with off-label indication has been published, as a bailout procedure.7–10 Considering the common sutureless concept, surgical AVR with a Perceval prosthesis fits well with such an indication. Notably, in the largest registry study by Roy et al.,9 up to 18.6% of patients necessitated a second transcatheter prosthesis implant due to residual regurgitation. No patient in the present study experienced prosthesis repositioning or other technical problems associated with prosthesis delivery. There is increasing evidence that for transcatheter sutureless prostheses preoperative echocardiographic measurement of the aortic annulus has inferior predictive value for prosthesis size compared with CT scan.11–13 Three dimensional reconstruction of the aortic root is better adapted to transform three-lobe circumference (native aortic annulus) into the diameter of a regular circular structure (aortic valve prosthesis). Further, it allows to account for elliptical conformation of the aortic annulus and the presence of eventual rough calcifications, that may distort it. Our echocardiographic data did not correlate well with the implanted prosthesis size, and future studies could address the precision and accuracy of CT predicted sutureless prosthesis size in patients with aortic regurgitation as the primary pathology. Theoretically, given the removal of diseased cusps, CT scan for surgical sutureless prostheses might demonstrate even better correlation with native aortic annulus diameter compared with transcatheter prostheses. Interestingly, in the present case series preoperative
echocardiographic evaluation of the native aortic annulus underestimated the prosthesis size (Fig. 1). Aortic valve pathology may play a role in this discrepancy; a regurgitant aortic valve without severe root/ annulus calcification retains elastic properties of the annulus (capacity to receive a greater prosthesis), while degenerative aortic stenosis renders the aortic root complex stiff and rigid. Experimental studies have demonstrated cyclic changes in the geometry of the aortic root, in particular, systolic expansion,14–16 and physiological dynamics of aortic root complex may be supported by the Perceval sutureless prosthesis, which features elastic Nitinol structure. Stented aortic prostheses are lacking annular distensibility, and may impede physiologic aortic root expansion after AVR. Substantial aortic root dilation occurs before the native cusps begin to open, which alone is thought to contribute 20% of cusp opening,17 thus sutureless valves may contribute to lower gradients and patient-prosthesis mismatch incidence. There are several limitations to our study. As a retrospective study without a control group, there may be biases that could confound our findings, which were not adjusted for. Small sample size and extremely heterogeneous study population may account for skewness of continuous data and abnormal distribution of dichotomous ones. The follow-up period was relatively short. REFERENCES 1. Folliguet TA, Laborde F, Zannis K, et al: Sutureless Perceval aortic valve replacement: Results of two European centers. Ann Thorac Surg 2012;93:1483–1488. 2. Miceli A, Santarpino G, Pfeiffer S, et al: Minimally invasive aortic valve replacement with Perceval S sutureless valve: Early outcomes and one-year survival from two European centers. J Thorac Cardiovasc Surg. 2014;148:2838–43. 3. Gilmanov D, Miceli A, Ferrarini M, et al.: Aortic valve replacement through right anterior minithoracotomy: Can sutureless technology improve clinical outcomes. Ann Thorac Surg 2014;98:1585–1592. 4. Santarpino G, Pfeiffer S, Schmidt J, et al: Sutureless aortic valve replacement: First-year single-center experience. Ann Thorac Surg 2012;94:504–509. 5. Gilmanov D, Miceli A, Bevilacqua S, et al: Sutureless implantation of the Perceval S aortic valve prosthesis
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