ORIGINAL ARTICLE – ADULT CARDIAC
Interactive CardioVascular and Thoracic Surgery 18 (2014) 432–437 doi:10.1093/icvts/ivt530 Advance Access publication 6 January 2014
Long-term results of aortic valve resuspension in patients with aortic valve insufficiency and aortic root aneurysm† Nadejda Monsefi* a, Andreas Zierera, Petar Risteskia, Patrick Primbsa, Aleksandra Miskovica, Afsaneh Karimian-Tabrizia, Sandra Folkmannb and Anton Moritza a b
Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany Department of Cardiovascular Surgery, Hietzing Hospital, Vienna, Austria
* Corresponding author. Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University Hospital, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. Tel: +49-69-63014071; fax: +49-69-63015849; e-mail: [email protected] (N. Monsefi). Received 14 September 2013; received in revised form 12 November 2013; accepted 18 November 2013
Abstract OBJECTIVES: ‘The David technique’ may provide an alternative to conduit implantation in patients with an aneurysm of the ascending aorta and aortic valve insufficiency. METHODS: From 1991 to 2013, the David technique was performed in 249 consecutive patients in our department. The patient mean age was 58 ± 14 years; 71 (29%) were female and 178 (71%) male. A modification of the David technique was performed by creating a pseudosinus in 43 patients (17%) and by creating a neosinus in 123 patients (49%). The mean follow-up was 6 ± 4.5 years. RESULTS: There were six in-hospital (2.4%) and 30 late deaths (2.4%/patient-year). Cardiac-related events were the cause of death in three patients. The Kaplan–Meier estimate for 10 years survival was 77%. Four patients had perioperative neurological events, and only eight neurological events occurred during follow-up (0.6%/patient-year). Ten patients (0.8%/patient-year) required aortic valve replacement; one because of combined aortic valve stenosis and insufficiency and nine because of severe aortic valve insufficiency as a result of leaflet prolapse (n = 3), leaflet perforation (n = 1), abridgement of the right coronary leaflet (n = 1) and because of endocarditis (n = 4). Three cases of bleeding were observed (0.24%/patient-year). Freedom from reoperation or aortic valve insufficiency ≥2° was 80% at 10 years. CONCLUSIONS: Aortic valve sparing to treat patients with an ascending aortic aneurysm with aortic valve insufficiency is a durable procedure. Aortic valve function remains stable for many years. Valve-related complications are rare, and the rate of reoperations is not increased in comparison to conduit root replacement. Keywords: Aortic valve repair • Aortic root
INTRODUCTION
PATIENTS AND METHODS
Aortic valve-sparing operations for the treatment of aortic insufficiency (AI) or aortic root dilatation with aneurysm of the aorta have been performed by many institutions, with outstanding longterm results [1–3]. Several modifications have been presented over the years [4, 5]. The advantages of aortic valve-preserving procedures seem obvious, because no anticoagulation is necessary, in contrast to the use of mechanical valves, and there is no limit to durability as is the case for bioprosthetic valves. Over the past 22 years, we have performed 249 David procedures and developed modifications, such as a technique for creation of sinuses. In the present study, we focused on the postoperative and follow-up results and compared patients without (group 1) and those with deterioration of valve function defined as reoperation or AI ≥ 2° (group 2). We tried to identify risk factors and their impact on late outcome.
From 1991 to 2013, 249 consecutive patients with an ascending aortic aneurysm and aortic valve insufficiency underwent replacement of the ascending aorta and resuspension of the aortic valve in our department. Their mean age was 58 ± 14 years (range 18– 87 years). Table 1 summarizes the characteristics of the patients. The operative technique has been described in former publications [6]. Until 2004, we performed the standard David technique [7]. Later, we modified the procedure, initially by creating a pseudosinus to reduce leaflet stress [6]. For this, we took a graft size with a diameter twice the leaflet height. In patients with a normal, non-dilated annulus, the size of graft was caculated by the annular diameter, adding about 2 mm for aortic wall thickness and an additional 5 mm in order to create the pseudosinus. At the base of each commissure, 5 mm triangular bites were passed parallel and perpendicular to the lower edge of the prosthesis. In a previous publication, we showed that the valve opening velocity could be reduced in patients who received the pseudosinus procedure in comparison to the standard David technique in our institution.
*Presented at the 27th Annual Meeting of the European Association for CardioThoracic Surgery, Vienna, Austria, 5-9 October 2013.
© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
N. Monsefi et al. / Interactive CardioVascular and Thoracic Surgery
are expressed as frequencies. Continuous variables are expressed as means ± SD. Long-term survival, freedom from reoperation and freedom from moderate or severe AI were calculated according to the Kaplan–Meier method and compared by log-rank test between patient groups. Logistic regression models were used to analyse independent associations with postoperative AI ≥ 2° or reoperation; univariate analysis was performed with the log-rank test (Peto–Pike/Cox–Mantel) between the patient groups (Tables 1–4). There were few adverse events in our series, and the number of patients in some subgroups was also too small for generating significant multivariate analysis.
RESULTS Perioperative outcome The in-hospital mortality was 2.4% (n = 6) in total. Three patients died of multiorgan failure, two of low-output syndrome (one of them belonged to group 2) and one of rupture of an abdominal aneurysm. We noticed four neurological events perioperatively; all of these patients belonged to group 1. One patient had temporary and three permanent neurological deficits (two with critical illness polyneuropathy and one focal event). Table 2 illustrates the perioperative results and surgical procedures. There were no relevant differences in cardiopulmonary bypass time, myocardial ischaemic time, intensive care unit stay or ventilation time between the two groups; however, there were significant differences in operative techniques. In group 1, more operations made use of the neosinus technique (118 vs 5, P = 0.03) and more supra-annular stitches (48 vs 0, P = 0.02) were performed. Performance of the neosinus technique or of the supra-annular stitch emerged as protective against the development of postoperative AI ≥ 2° or reoperation by univariate analysis.
Follow-up Statistical analysis All statistical analyses were performed with BIAS 9.05 software (Epsilon Publishing, Darmstadt, Germany). Categorical variables
We registered 29 late deaths in group 1 and one in group 2. One patient died of rupture of the descending aorta and three had rupture of the abdominal aorta. One patient suffered from respiratory failure, two from gastrointestinal bleeding and another one from lung cancer. Two patients died of sepsis and one of acute
Table 1: Patient characteristics Characteristic
All
Group 1
Group 2
P-value
Number of patients Age (years) Male [n (%)] Hypertension [n (%)] Marfan syndrome [n (%)] Diameter of ascending aorta (cm) Type A dissection [n (%)] Aortic valve morphology: bicuspid/tricuspid (n)
249 58 ± 14 178 (71%) 115 (46%) 20 (8%) 5.7 ± 1 28 (11%)
227 59 ± 14 162 (71%) 103 (45%) 20 (9%) 5.7 ± 1 23 (10%)
22 56 ± 13 16 (73%) 12 (55%) 0 5.8 ± 1 5 (25%)
0.5 0.6 0.7 0.2 0.4 0.2
25/224
22/205
3/19
0.8
Group 1: event-free patients; group 2: patients with following event of AI ≥ 2° or reoperation.
ORIGINAL ARTICLE
As a next step, we created a neosinus [4] to optimize the aortic cusp dynamics by lowering the valve opening velocity compared with the pseudosinus technique and reducing leaflet stress [8]. We plicated the base and the sinotubular junction of the graft with three 4–0 braided polyester sutures. At the base of each commissure, 5–7 mm bites were passed parallel to the lower edge of the prosthesis. The second bite of the same suture was passed perpendicularly to the first, in order to catch 5 mm of prosthesis height. Placing three stitches at the base in this fashion reduces the diameter and local height of the base and creates a more physiological protrusion of the graft. Bites for resuspension of the commissures were taken 5–7 mm wider at the prostheses. This created the anatomical diameter reduction of the sinotubular junction. Again, three 4–0 stitches were placed at the outside to reinforce the diameter reduction, and the perpendicular bites again reduced the height at the commissures to increase the bulge of the sinuses. In cases of bicuspid aortic valves, we modified the David procedure, mainly by augmenting the fused leaflet with a patch [9]. To avoid distortion of the right coronary cusp, the deepest or ‘central’ stitch at the right sinus was placed in a supra-annular position, because the prostheses cannot be brought down below the annulus owing to the septal muscle shelf [10]. We performed this step in 48 patients (all in group 1). The function of the aortic valve was determined intraoperatively with transoesophageal echocardiography. Transthoracic echocardiograms were performed before discharge from the hospital and at follow-up. Patients did not receive oral anticoagulants except when indicated by additional disease. Ten patients were lost to follow-up (95% complete). The mean follow-up was 5.7 ± 4.5 years, with 1239 cumulative patient-years. We compared patients without (group 1, n = 227) and those with deterioration of valve function defined as reoperation or AI ≥ 2° (group 2, n = 22). We tried to identify risk factors and their impact on late outcome using univariate analysis between the two groups. The study was approved by our institutional ethics committee.
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Table 2: Perioperative results and surgical procedures Procedure/result Surgical procedures Neosinus/pseudosinus/standard (n) Isolated ascending aorta replacement [n (%)] Ascending aorta and hemiarch replacement [n (%)] Complete arch replacement or elephant trunk [n (%)] Concomitant procedures Coronary artery bypass grafting [n (%)] Atrial septal defect closure [n (%)] Mitral valve repair [n (%)] Tricuspid valve repair [n (%)] Leaflet plication of the aortic valve [n (%)] Supra-annular stitch [n (%)] Perioperative data Cardiopulmonary bypass time (min) Myocardial ischaemic time (min) Intensive care unit stay (days) Ventilation time (h) Need for re-exploration [n (%)] Temporary neurological deficit [n (%)] Permanent neurological deficit [n (%)] In-hospital mortality [n (%)]
All (n = 249)
Group 1 (n = 227)
Group 2 (n = 22)
P-value
123/43/83 167 (67%) 58 (23%) 24 (10%)
118/36/73 151 (67%) 53 (23%) 23 (10%)
5/7/10 16 (73%) 5 (23%) 1 (4%)
0.03/0.8/0.3 0.9 0.5 0.3
40 (16%) 5 (2%) 12 (5%) 5 (2%) 82 (33%) 48 (19%)
34 (15%) 5 (2%) 10 (4%) 5 (2%) 76 (33%) 48 (21%)
6 (27%) 0 2 (9%) 0 6 (27%) 0
0.4 0.5 0.6 0.5 0.3 0.02
197 ± 45 145 ± 31 2.4 ± 5 33 ± 70 29 (12%) 1 (0.4%) 3 (1.2%) 6 (2.4%)
196 ± 44 145 ± 31 2.4 ± 5 33 ± 91 26 (11%) 1 (0.4%) 3 (1.3%) 5 (2%)
198 ± 45 146 ± 30 2.3 ± 3 32 ± 51 3 (14%) 0 0 1 (5%)
0.5 0.4 0.7 0.9 0.7 0.7 0.6 0.5
Group 1: event-free patients; group 2: patients with following event of AI ≥ 2° or reoperation.
Table 3: Follow-up data (group 1: 1106 patient-years, mean 5.7 ± 4.6 years follow-up; and group 2: 133 patient-years, mean 6.1 ± 4 years follow-up) Event [n (%/patient-year)]
Late mortality Endocarditis Late neurological events Total Stroke, TIA Cerebral bleeding All cases of bleeding Anticoagulation-related bleeding Reoperation
All
Group 1
30 (2.4) 4 (0.3)
29 (2.6) 0
8 (0.6) 7 (0.6) 1 (0.08) 3 (0.24) 1 (0.08) 10 (0.8)
6 (0.5) 5 (0.45) 1 (0.09) 3 (0.27) 1 (0.09) 0
Group 2
P-value
1 (0.75) 4 (3)
0.2
Interactive CardioVascular and Thoracic Surgery 18 (2014) 432–437 doi:10.1093/icvts/ivt530 Advance Access publication 6 January 2014
Long-term results of aortic valve resuspension in patients with aortic valve insufficiency and aortic root aneurysm† Nadejda Monsefi* a, Andreas Zierera, Petar Risteskia, Patrick Primbsa, Aleksandra Miskovica, Afsaneh Karimian-Tabrizia, Sandra Folkmannb and Anton Moritza a b
Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany Department of Cardiovascular Surgery, Hietzing Hospital, Vienna, Austria
* Corresponding author. Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University Hospital, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. Tel: +49-69-63014071; fax: +49-69-63015849; e-mail: [email protected] (N. Monsefi). Received 14 September 2013; received in revised form 12 November 2013; accepted 18 November 2013
Abstract OBJECTIVES: ‘The David technique’ may provide an alternative to conduit implantation in patients with an aneurysm of the ascending aorta and aortic valve insufficiency. METHODS: From 1991 to 2013, the David technique was performed in 249 consecutive patients in our department. The patient mean age was 58 ± 14 years; 71 (29%) were female and 178 (71%) male. A modification of the David technique was performed by creating a pseudosinus in 43 patients (17%) and by creating a neosinus in 123 patients (49%). The mean follow-up was 6 ± 4.5 years. RESULTS: There were six in-hospital (2.4%) and 30 late deaths (2.4%/patient-year). Cardiac-related events were the cause of death in three patients. The Kaplan–Meier estimate for 10 years survival was 77%. Four patients had perioperative neurological events, and only eight neurological events occurred during follow-up (0.6%/patient-year). Ten patients (0.8%/patient-year) required aortic valve replacement; one because of combined aortic valve stenosis and insufficiency and nine because of severe aortic valve insufficiency as a result of leaflet prolapse (n = 3), leaflet perforation (n = 1), abridgement of the right coronary leaflet (n = 1) and because of endocarditis (n = 4). Three cases of bleeding were observed (0.24%/patient-year). Freedom from reoperation or aortic valve insufficiency ≥2° was 80% at 10 years. CONCLUSIONS: Aortic valve sparing to treat patients with an ascending aortic aneurysm with aortic valve insufficiency is a durable procedure. Aortic valve function remains stable for many years. Valve-related complications are rare, and the rate of reoperations is not increased in comparison to conduit root replacement. Keywords: Aortic valve repair • Aortic root
INTRODUCTION
PATIENTS AND METHODS
Aortic valve-sparing operations for the treatment of aortic insufficiency (AI) or aortic root dilatation with aneurysm of the aorta have been performed by many institutions, with outstanding longterm results [1–3]. Several modifications have been presented over the years [4, 5]. The advantages of aortic valve-preserving procedures seem obvious, because no anticoagulation is necessary, in contrast to the use of mechanical valves, and there is no limit to durability as is the case for bioprosthetic valves. Over the past 22 years, we have performed 249 David procedures and developed modifications, such as a technique for creation of sinuses. In the present study, we focused on the postoperative and follow-up results and compared patients without (group 1) and those with deterioration of valve function defined as reoperation or AI ≥ 2° (group 2). We tried to identify risk factors and their impact on late outcome.
From 1991 to 2013, 249 consecutive patients with an ascending aortic aneurysm and aortic valve insufficiency underwent replacement of the ascending aorta and resuspension of the aortic valve in our department. Their mean age was 58 ± 14 years (range 18– 87 years). Table 1 summarizes the characteristics of the patients. The operative technique has been described in former publications [6]. Until 2004, we performed the standard David technique [7]. Later, we modified the procedure, initially by creating a pseudosinus to reduce leaflet stress [6]. For this, we took a graft size with a diameter twice the leaflet height. In patients with a normal, non-dilated annulus, the size of graft was caculated by the annular diameter, adding about 2 mm for aortic wall thickness and an additional 5 mm in order to create the pseudosinus. At the base of each commissure, 5 mm triangular bites were passed parallel and perpendicular to the lower edge of the prosthesis. In a previous publication, we showed that the valve opening velocity could be reduced in patients who received the pseudosinus procedure in comparison to the standard David technique in our institution.
*Presented at the 27th Annual Meeting of the European Association for CardioThoracic Surgery, Vienna, Austria, 5-9 October 2013.
© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
N. Monsefi et al. / Interactive CardioVascular and Thoracic Surgery
are expressed as frequencies. Continuous variables are expressed as means ± SD. Long-term survival, freedom from reoperation and freedom from moderate or severe AI were calculated according to the Kaplan–Meier method and compared by log-rank test between patient groups. Logistic regression models were used to analyse independent associations with postoperative AI ≥ 2° or reoperation; univariate analysis was performed with the log-rank test (Peto–Pike/Cox–Mantel) between the patient groups (Tables 1–4). There were few adverse events in our series, and the number of patients in some subgroups was also too small for generating significant multivariate analysis.
RESULTS Perioperative outcome The in-hospital mortality was 2.4% (n = 6) in total. Three patients died of multiorgan failure, two of low-output syndrome (one of them belonged to group 2) and one of rupture of an abdominal aneurysm. We noticed four neurological events perioperatively; all of these patients belonged to group 1. One patient had temporary and three permanent neurological deficits (two with critical illness polyneuropathy and one focal event). Table 2 illustrates the perioperative results and surgical procedures. There were no relevant differences in cardiopulmonary bypass time, myocardial ischaemic time, intensive care unit stay or ventilation time between the two groups; however, there were significant differences in operative techniques. In group 1, more operations made use of the neosinus technique (118 vs 5, P = 0.03) and more supra-annular stitches (48 vs 0, P = 0.02) were performed. Performance of the neosinus technique or of the supra-annular stitch emerged as protective against the development of postoperative AI ≥ 2° or reoperation by univariate analysis.
Follow-up Statistical analysis All statistical analyses were performed with BIAS 9.05 software (Epsilon Publishing, Darmstadt, Germany). Categorical variables
We registered 29 late deaths in group 1 and one in group 2. One patient died of rupture of the descending aorta and three had rupture of the abdominal aorta. One patient suffered from respiratory failure, two from gastrointestinal bleeding and another one from lung cancer. Two patients died of sepsis and one of acute
Table 1: Patient characteristics Characteristic
All
Group 1
Group 2
P-value
Number of patients Age (years) Male [n (%)] Hypertension [n (%)] Marfan syndrome [n (%)] Diameter of ascending aorta (cm) Type A dissection [n (%)] Aortic valve morphology: bicuspid/tricuspid (n)
249 58 ± 14 178 (71%) 115 (46%) 20 (8%) 5.7 ± 1 28 (11%)
227 59 ± 14 162 (71%) 103 (45%) 20 (9%) 5.7 ± 1 23 (10%)
22 56 ± 13 16 (73%) 12 (55%) 0 5.8 ± 1 5 (25%)
0.5 0.6 0.7 0.2 0.4 0.2
25/224
22/205
3/19
0.8
Group 1: event-free patients; group 2: patients with following event of AI ≥ 2° or reoperation.
ORIGINAL ARTICLE
As a next step, we created a neosinus [4] to optimize the aortic cusp dynamics by lowering the valve opening velocity compared with the pseudosinus technique and reducing leaflet stress [8]. We plicated the base and the sinotubular junction of the graft with three 4–0 braided polyester sutures. At the base of each commissure, 5–7 mm bites were passed parallel to the lower edge of the prosthesis. The second bite of the same suture was passed perpendicularly to the first, in order to catch 5 mm of prosthesis height. Placing three stitches at the base in this fashion reduces the diameter and local height of the base and creates a more physiological protrusion of the graft. Bites for resuspension of the commissures were taken 5–7 mm wider at the prostheses. This created the anatomical diameter reduction of the sinotubular junction. Again, three 4–0 stitches were placed at the outside to reinforce the diameter reduction, and the perpendicular bites again reduced the height at the commissures to increase the bulge of the sinuses. In cases of bicuspid aortic valves, we modified the David procedure, mainly by augmenting the fused leaflet with a patch [9]. To avoid distortion of the right coronary cusp, the deepest or ‘central’ stitch at the right sinus was placed in a supra-annular position, because the prostheses cannot be brought down below the annulus owing to the septal muscle shelf [10]. We performed this step in 48 patients (all in group 1). The function of the aortic valve was determined intraoperatively with transoesophageal echocardiography. Transthoracic echocardiograms were performed before discharge from the hospital and at follow-up. Patients did not receive oral anticoagulants except when indicated by additional disease. Ten patients were lost to follow-up (95% complete). The mean follow-up was 5.7 ± 4.5 years, with 1239 cumulative patient-years. We compared patients without (group 1, n = 227) and those with deterioration of valve function defined as reoperation or AI ≥ 2° (group 2, n = 22). We tried to identify risk factors and their impact on late outcome using univariate analysis between the two groups. The study was approved by our institutional ethics committee.
433
N. Monsefi et al. / Interactive CardioVascular and Thoracic Surgery
434
Table 2: Perioperative results and surgical procedures Procedure/result Surgical procedures Neosinus/pseudosinus/standard (n) Isolated ascending aorta replacement [n (%)] Ascending aorta and hemiarch replacement [n (%)] Complete arch replacement or elephant trunk [n (%)] Concomitant procedures Coronary artery bypass grafting [n (%)] Atrial septal defect closure [n (%)] Mitral valve repair [n (%)] Tricuspid valve repair [n (%)] Leaflet plication of the aortic valve [n (%)] Supra-annular stitch [n (%)] Perioperative data Cardiopulmonary bypass time (min) Myocardial ischaemic time (min) Intensive care unit stay (days) Ventilation time (h) Need for re-exploration [n (%)] Temporary neurological deficit [n (%)] Permanent neurological deficit [n (%)] In-hospital mortality [n (%)]
All (n = 249)
Group 1 (n = 227)
Group 2 (n = 22)
P-value
123/43/83 167 (67%) 58 (23%) 24 (10%)
118/36/73 151 (67%) 53 (23%) 23 (10%)
5/7/10 16 (73%) 5 (23%) 1 (4%)
0.03/0.8/0.3 0.9 0.5 0.3
40 (16%) 5 (2%) 12 (5%) 5 (2%) 82 (33%) 48 (19%)
34 (15%) 5 (2%) 10 (4%) 5 (2%) 76 (33%) 48 (21%)
6 (27%) 0 2 (9%) 0 6 (27%) 0
0.4 0.5 0.6 0.5 0.3 0.02
197 ± 45 145 ± 31 2.4 ± 5 33 ± 70 29 (12%) 1 (0.4%) 3 (1.2%) 6 (2.4%)
196 ± 44 145 ± 31 2.4 ± 5 33 ± 91 26 (11%) 1 (0.4%) 3 (1.3%) 5 (2%)
198 ± 45 146 ± 30 2.3 ± 3 32 ± 51 3 (14%) 0 0 1 (5%)
0.5 0.4 0.7 0.9 0.7 0.7 0.6 0.5
Group 1: event-free patients; group 2: patients with following event of AI ≥ 2° or reoperation.
Table 3: Follow-up data (group 1: 1106 patient-years, mean 5.7 ± 4.6 years follow-up; and group 2: 133 patient-years, mean 6.1 ± 4 years follow-up) Event [n (%/patient-year)]
Late mortality Endocarditis Late neurological events Total Stroke, TIA Cerebral bleeding All cases of bleeding Anticoagulation-related bleeding Reoperation
All
Group 1
30 (2.4) 4 (0.3)
29 (2.6) 0
8 (0.6) 7 (0.6) 1 (0.08) 3 (0.24) 1 (0.08) 10 (0.8)
6 (0.5) 5 (0.45) 1 (0.09) 3 (0.27) 1 (0.09) 0
Group 2
P-value
1 (0.75) 4 (3)
0.2
