https://orcid.org/0000-0002-6137-1273
Abstract
This study was undertaken to analyse outcomes of aortic valve repair using additional material and compare the results to those of cusp repair without the use of the pericardial patch.
All consecutive patients aged over 16 who underwent aortic valve repair with external ring annuloplasty for isolated aortic insufficiency, aortic insufficiency and tubular aortic aneurysm or aortic root aneurysm between May 2003 and November 2019 were included in a cohort study. Data were collected and analysed from the AVIATOR registry (AorticValve repair InternATiOnal Registry). Propensity score framework analysis (inverse probability of treatment weighting) was used to compare outcomes of the groups while controlling for confounders.
During the 16-year study period, 618 patients underwent aortic valve repair. Eight-year survival rate was 92% in the patch group and 90.2% in the no patch group without significant differences [P = 0.957 inverse probability of treatment weighting (IPTW) weighted]. Early valve-related reoperation was more frequent in the patch group as compared to the no patch group (6% vs 1%, P < 0.001 IPTW weighted), the freedom from aortic valve-related reintervention and from structural valve deterioration at 8 years was not significantly different between the patch and no patch groups (93.7% vs 94%, P = 0.968 IPTW weighted; and 99.3% vs 96.7%, P = 0.964 IPTW weighted).
Although a higher rate of early reintervention was observed, aortic valve repair using the pericardial patch, in a standardized approach using external annuloplasty, with effective coaptation height of at least 9 mm, was not associated with an increase in mid-term aortic valve-related reoperation or structural valve deterioration as compared to valve repair without the pericardial patch.
INTRODUCTION
Aortic valvuloplasty techniques for aortic insufficiency (AI) are becoming more and more standardized allowing good long-term results with low rates of valve-related events [1–3]. Thus, aortic valve repair is recommended as the first-line strategy in patients with tricuspid or bicuspid valves who have type I or II mechanism of AI [4, 5]. In previous studies, aortic valve repair techniques using pericardial patches were associated with high long-term valve-related reoperation rates and less successful surgical repair than an aortic valvuloplasty without the use of additional material [6]. In this complex situation, many surgical teams prefer to switch from a complex aortic valve repair to Ross procedure or aortic valve replacement (AVR) [7–9]. However, there is a considerable variety of repair techniques. Indeed, aortic valvuloplasty using pericardial patch has never been evaluated in standardized aortic valve repair procedures such as valve-sparing root replacement according to the remodelling root repair with a subvalvular annuloplasty or double sub- and supracoronary external aortic ring annuloplasty.
This study was undertaken to analyse short- and mid-term outcomes of aortic valve repair using additional material and compare the results to those of cusp repair without the use of the pericardial patch.
MATERIALS AND METHODS
Study design and ethics statement
All consecutive patients aged over 16 years who underwent aortic valve repair with aortic ring annuloplasty either for isolated AI, AI and tubular aortic aneurysm or aortic root aneurysm between May 2003 and November 2019 were included. Data were prospectively collected and retrospectively analysed from the AVIATOR registry (AorticValve repair InternATiOnal Registry) [10]. Interventions were performed by or under the proctorship of Dr Lansac (9 surgeons overall) in 4 French cardiac surgery departments (Institut Mutualiste Montsouris, Pitié-Salpêtrière hospital, Bichat hospital and Foch hospital, Paris, France). This study was approved by the institutional review boards for the multicentric AVIATOR (Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le Domaine de la Santé no. 13 738 Bis) and the multicentric Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root (CAVIAAR) trial (Comité de Protection des Personnes Ile de France VI A00362-49). The need for individual patient consent was waived.
Surgical techniques
The operative techniques of aortic valve repair for isolated AI, tubular aortic aneurysm or aortic root aneurysm were previously described [3, 11, 12]. In the case of aortic root aneurysm (sinus of Valsalva >45 mm), a valve-sparing root replacement according to the remodelling technique with a subvalvular annuloplasty was performed. In the case of isolated AI (all ascending aorta diameter <40 mm), a double sub- and supracoronary external aortic annuloplasty was performed. Finally, in the case of tubular aortic aneurysm (sinuses of Valsalva <40–45 mm), the root was preserved, a subvalvular annuloplasty was performed and the tubular aorta was replaced by a supracoronary graft.
Four different techniques of aortic valve repair using pericardial patch were used depending on the lesions: (i) in case of cusp retraction whatever the number of cusps, a valve extension at the belly after disinsertion of the cusp was performed with the pericardial patch was used to obtain an effective height of at least 9 mm [13]. However, in the case of extended calcification, the repair was aborded. (ii) Fenestrations that did not induce AI were not repaired. However, if fenestration (whatever the number of cusps) was involved in the mechanism of a cusp prolapse (elongation of the free margin of the cusp), the area of the fenestration was closed and reinforced using a pericardial patch. Multiple large fenestrations with thin cusp tissues particularly in elderly patients and restrictive AI without annular dilatation are a limitation/contraindication of the aortic valve repair. (iii) Defect or destruction at the nadir of a cusp like seen in infective endocarditis can be closed with a pericardial patch [14]. (iv) Unicuspid aortic valves were corrected by symmetric bicuspidization technique [15, 16]: after excision of the 2 rudimentary commissures, 2 triangular autologous treated pericardial patches were used to create a new commissure opposite to the preserved native commissure (Video 1). If necessary, alignment of cusp-free edges and correction of cusp prolapse through central plicating stitches were performed to obtain an effective height of 9 mm. Bicuspid valves are treated as follows: (i) restoring cusp configuration with central cusp plication, raphe closure; (ii) improving valve geometry, making it more symmetrical to a commissure orientation at 180° according to the remodelling technique with 2 symmetrical scallops in case of root replacement, or with sinus plication associated to an hemi-remodelling technique replacing supracoronary and non-coronary sinus or sinus plication in case of tubular aorta aneurysm or with sinus plication and sinotubular junction ring annuloplasty; and (iii) reducing the annulus with an external subvalvular annuloplasty to increase the surface of coaptation and protect the repair. If autologous pericardial patch was used, pericardium was tanned in a 0.2% glutaraldehyde solution for 1–2 min and then rinsed in physiological saline solution. Only CardioCel® (Admedus Ltd, Australia) was used as heterologous pericardial patch in this study. The surgical result was then checked intraoperatively by trans-oesophageal ultrasound. Residual AI ≤ mild (I) was considered satisfactory (if central and not eccentric).
Outcome variables
The main outcome variables were aortic valve-related reoperation at discharge (early) and follow-up. Second end points were early postoperative outcomes, mortality at discharge (early) and follow-up, freedom from structural valve deterioration (SVD), from AI ≥ II, from thrombosis and from infective endocarditis at follow-up. Definitions of outcomes are included in the Supplementary Material. Clinical and echocardiographic follow-ups were updated at the end of May 2020.
Statistical analysis
Categorical variables were expressed as percentages and were compared using chi-squared tests or Fischer’s exact tests, as appropriate. Continuous variables were expressed as means (standard deviations) or medians (interquartile range) and were compared using the Wilcoxon rank-sum test or Student’s t-test, as appropriate. To address confounding caused by the differing baseline patient characteristics, a propensity score with inverse probability of treatment weighting (IPTW) was generated [17]. Details of propensity score analyses are included in the statistical analysis plan (Supplementary Material). Comparison between the patch group and the no-patch group regarding survival, freedom from aortic valve-related reintervention, from infective endocarditis, from SVD, from AI ≥ 3 and from AI ≥ 2 at follow-up was assessed using the Kaplan–Meier method (log-rank test was used for comparison between groups). Factors associated with reoperation were assessed by the Cox regression analysis, using a backward stepwise algorithm (based on likelihood-ratio test). Relevant variables significant at the 15% level on univariate analysis were included. Validity of the Cox models was done by testing proportional hazards assumption using global test and Schoenfeld residuals. Odds ratios were provided with 95% confidence intervals. A P-value of <0.05 was considered statistically significant. All calculations and figures were made using SPSS® v24.0 and R® v3.5.1.
RESULTS
Patients and operative data
During the 16-year study period, 643 patients underwent aortic valve repair for isolated AI, AI with tubular aortic aneurysm or AI with aortic root aneurysm. Eleven initial decisions of aortic valvuloplasty were intraoperatively switched to biological AVR (n = 2) or mechanical AVR (n = 9) because the aortic valve was too retracted and/or calcified. Five patients were intraoperatively switched to AVR (1 mechanical and 4 biological) because of failure of aortic valve repair. Characteristics of these 5 failures repair are presented in Supplementary Material, Table S1. These 5 patients had tricuspid valves and 3 patients had at least 1 cusp retracted. Baseline characteristics of the patch (n = 63) and no-patch (n = 580) groups before and after propensity score analysis are presented in Table 1. Clinical follow-up was completed in 94% of cases and echocardiographic follow-up was completed in 88% of cases. The mean clinical and echocardiography follow-ups were 55.6 (8.4–102.8) and 49.2 (6.5–91.9) months in the no-patch group and 40.8 (1.8–79.8) and 36 (6–66) months in the patch group. Preoperative echocardiography and operative data before and after propensity score analysis are presented in Supplementary Material, Table S2.
Baseline characteristics of entire study cohort before and after inverse probability treatment weighting
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | Standardized mean difference | |
| Age, years, median (IQR) | 46 (30.2–61.8) | 51.2 (35.9–66.5) | 0.022 | 51.6 (36.9–66.3) | 50.7 (35.3–66.1) | 0.065 |
| Male, n (%) | 50 (79) | 480 (83) | 0.46 | 51 (83) | 469 (83) | 0.001 |
| Weight, kg, median (IQR) | 78.6 (59.5–91.7) | 79.7 (62.9–96.5) | 0.403 | 81.5 (64.1–98.9) | 79.7 (62.9–96.5) | 0.10 |
| Height, cm, median (IQR) | 175 (166–184) | 175 (164–186) | 0.853 | 176 (165–187) | 175 (164–186) | 0.09 |
| NYHA, n (%) | 0.175 | 0.20 | ||||
| I | 25 (42) | 298 (54) | 28 (45) | 305 (54) | ||
| II | 28 (47) | 213 (39) | 28 (45) | 226 (40) | ||
| III | 6 (10) | 36 (6) | 6 (10) | 40 (7) | ||
| IV | 1 (2) | 3 (1) | 1 (1) | 6 (1) | ||
| EuroSCORE II, median (IQR) | 2 (0.1–3.9) | 2.3 (0.1–4.6) | 0.278 | 2.4 (0.6–4.2) | 2.3 (0.1–4.8) | 0.041 |
| COPD, n (%) | 0 (0) | 14 (2) | 0.382 | 0 (0) | 11 (2) | 0.14 |
| IDDM, n (%) | 1 (2) | 6 (1) | 0.512 | 1 (1) | 6 (1) | 0.001 |
| Extracardiac arteriopathy, n (%) | 1 (2) | 11 (2) | 0.612 | 0 (0) | 6 (1) | 0.09 |
| History of chronic renal failure requiring hemodialysis, n (%) | 0 (0) | 1 (0.2) | 1.000 | 0 (0) | 6 (1) | 0.09 |
| Preoperative creatinine value (µmol/l), median (IQR) | 0.97 (0.54–1.4) | 0.97 (0.62–1.32) | 0.076 | 0.94 (0.6–1.28) | 0.98 (0.6–1.36) | 0.10 |
| History of cardiac surgery, n (%) | 6 (10) | 30 (5) | 0.148 | 19 (31) | 217 (33) | 0.002 |
| Connective tissue disease, n (%) | 3 (5) | 59 (10) | 0.173 | 4 (6) | 56 (10) | 0.138 |
| Additional procedures, n (%) | 14 (22) | 147 (25) | 0.449 | 15 (25) | 158 (25) | 0.001 |
| CABG | 0 (0) | 29 (5) | 3 (5) | 0 (0) | ||
| Mitral valve | 2 (3) | 37 (6) | 2 (3) | 34 (6) | ||
| Tricuspid valve | 2 (3) | 8 (1) | 3 (5) | 11 (2) | ||
| MAZE | 4 (6) | 29 (5) | 6 (9) | 28 (5) | ||
| Aortic arch | 0 (0) | 15 (3) | 0 (0) | 17 (3) | ||
| Other | 6 (10) | 29 (5) | 11 (17) | 68 (12) | ||
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | Standardized mean difference | |
| Age, years, median (IQR) | 46 (30.2–61.8) | 51.2 (35.9–66.5) | 0.022 | 51.6 (36.9–66.3) | 50.7 (35.3–66.1) | 0.065 |
| Male, n (%) | 50 (79) | 480 (83) | 0.46 | 51 (83) | 469 (83) | 0.001 |
| Weight, kg, median (IQR) | 78.6 (59.5–91.7) | 79.7 (62.9–96.5) | 0.403 | 81.5 (64.1–98.9) | 79.7 (62.9–96.5) | 0.10 |
| Height, cm, median (IQR) | 175 (166–184) | 175 (164–186) | 0.853 | 176 (165–187) | 175 (164–186) | 0.09 |
| NYHA, n (%) | 0.175 | 0.20 | ||||
| I | 25 (42) | 298 (54) | 28 (45) | 305 (54) | ||
| II | 28 (47) | 213 (39) | 28 (45) | 226 (40) | ||
| III | 6 (10) | 36 (6) | 6 (10) | 40 (7) | ||
| IV | 1 (2) | 3 (1) | 1 (1) | 6 (1) | ||
| EuroSCORE II, median (IQR) | 2 (0.1–3.9) | 2.3 (0.1–4.6) | 0.278 | 2.4 (0.6–4.2) | 2.3 (0.1–4.8) | 0.041 |
| COPD, n (%) | 0 (0) | 14 (2) | 0.382 | 0 (0) | 11 (2) | 0.14 |
| IDDM, n (%) | 1 (2) | 6 (1) | 0.512 | 1 (1) | 6 (1) | 0.001 |
| Extracardiac arteriopathy, n (%) | 1 (2) | 11 (2) | 0.612 | 0 (0) | 6 (1) | 0.09 |
| History of chronic renal failure requiring hemodialysis, n (%) | 0 (0) | 1 (0.2) | 1.000 | 0 (0) | 6 (1) | 0.09 |
| Preoperative creatinine value (µmol/l), median (IQR) | 0.97 (0.54–1.4) | 0.97 (0.62–1.32) | 0.076 | 0.94 (0.6–1.28) | 0.98 (0.6–1.36) | 0.10 |
| History of cardiac surgery, n (%) | 6 (10) | 30 (5) | 0.148 | 19 (31) | 217 (33) | 0.002 |
| Connective tissue disease, n (%) | 3 (5) | 59 (10) | 0.173 | 4 (6) | 56 (10) | 0.138 |
| Additional procedures, n (%) | 14 (22) | 147 (25) | 0.449 | 15 (25) | 158 (25) | 0.001 |
| CABG | 0 (0) | 29 (5) | 3 (5) | 0 (0) | ||
| Mitral valve | 2 (3) | 37 (6) | 2 (3) | 34 (6) | ||
| Tricuspid valve | 2 (3) | 8 (1) | 3 (5) | 11 (2) | ||
| MAZE | 4 (6) | 29 (5) | 6 (9) | 28 (5) | ||
| Aortic arch | 0 (0) | 15 (3) | 0 (0) | 17 (3) | ||
| Other | 6 (10) | 29 (5) | 11 (17) | 68 (12) | ||
CABG: coronary artery bypass graft; COPD: chronic obstructive pulmonary disease; IDDM: insulin-dependent diabetes mellitus; IPTW: inverse probability treatment weighting; IQR: interquartile range.
Baseline characteristics of entire study cohort before and after inverse probability treatment weighting
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | Standardized mean difference | |
| Age, years, median (IQR) | 46 (30.2–61.8) | 51.2 (35.9–66.5) | 0.022 | 51.6 (36.9–66.3) | 50.7 (35.3–66.1) | 0.065 |
| Male, n (%) | 50 (79) | 480 (83) | 0.46 | 51 (83) | 469 (83) | 0.001 |
| Weight, kg, median (IQR) | 78.6 (59.5–91.7) | 79.7 (62.9–96.5) | 0.403 | 81.5 (64.1–98.9) | 79.7 (62.9–96.5) | 0.10 |
| Height, cm, median (IQR) | 175 (166–184) | 175 (164–186) | 0.853 | 176 (165–187) | 175 (164–186) | 0.09 |
| NYHA, n (%) | 0.175 | 0.20 | ||||
| I | 25 (42) | 298 (54) | 28 (45) | 305 (54) | ||
| II | 28 (47) | 213 (39) | 28 (45) | 226 (40) | ||
| III | 6 (10) | 36 (6) | 6 (10) | 40 (7) | ||
| IV | 1 (2) | 3 (1) | 1 (1) | 6 (1) | ||
| EuroSCORE II, median (IQR) | 2 (0.1–3.9) | 2.3 (0.1–4.6) | 0.278 | 2.4 (0.6–4.2) | 2.3 (0.1–4.8) | 0.041 |
| COPD, n (%) | 0 (0) | 14 (2) | 0.382 | 0 (0) | 11 (2) | 0.14 |
| IDDM, n (%) | 1 (2) | 6 (1) | 0.512 | 1 (1) | 6 (1) | 0.001 |
| Extracardiac arteriopathy, n (%) | 1 (2) | 11 (2) | 0.612 | 0 (0) | 6 (1) | 0.09 |
| History of chronic renal failure requiring hemodialysis, n (%) | 0 (0) | 1 (0.2) | 1.000 | 0 (0) | 6 (1) | 0.09 |
| Preoperative creatinine value (µmol/l), median (IQR) | 0.97 (0.54–1.4) | 0.97 (0.62–1.32) | 0.076 | 0.94 (0.6–1.28) | 0.98 (0.6–1.36) | 0.10 |
| History of cardiac surgery, n (%) | 6 (10) | 30 (5) | 0.148 | 19 (31) | 217 (33) | 0.002 |
| Connective tissue disease, n (%) | 3 (5) | 59 (10) | 0.173 | 4 (6) | 56 (10) | 0.138 |
| Additional procedures, n (%) | 14 (22) | 147 (25) | 0.449 | 15 (25) | 158 (25) | 0.001 |
| CABG | 0 (0) | 29 (5) | 3 (5) | 0 (0) | ||
| Mitral valve | 2 (3) | 37 (6) | 2 (3) | 34 (6) | ||
| Tricuspid valve | 2 (3) | 8 (1) | 3 (5) | 11 (2) | ||
| MAZE | 4 (6) | 29 (5) | 6 (9) | 28 (5) | ||
| Aortic arch | 0 (0) | 15 (3) | 0 (0) | 17 (3) | ||
| Other | 6 (10) | 29 (5) | 11 (17) | 68 (12) | ||
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | Standardized mean difference | |
| Age, years, median (IQR) | 46 (30.2–61.8) | 51.2 (35.9–66.5) | 0.022 | 51.6 (36.9–66.3) | 50.7 (35.3–66.1) | 0.065 |
| Male, n (%) | 50 (79) | 480 (83) | 0.46 | 51 (83) | 469 (83) | 0.001 |
| Weight, kg, median (IQR) | 78.6 (59.5–91.7) | 79.7 (62.9–96.5) | 0.403 | 81.5 (64.1–98.9) | 79.7 (62.9–96.5) | 0.10 |
| Height, cm, median (IQR) | 175 (166–184) | 175 (164–186) | 0.853 | 176 (165–187) | 175 (164–186) | 0.09 |
| NYHA, n (%) | 0.175 | 0.20 | ||||
| I | 25 (42) | 298 (54) | 28 (45) | 305 (54) | ||
| II | 28 (47) | 213 (39) | 28 (45) | 226 (40) | ||
| III | 6 (10) | 36 (6) | 6 (10) | 40 (7) | ||
| IV | 1 (2) | 3 (1) | 1 (1) | 6 (1) | ||
| EuroSCORE II, median (IQR) | 2 (0.1–3.9) | 2.3 (0.1–4.6) | 0.278 | 2.4 (0.6–4.2) | 2.3 (0.1–4.8) | 0.041 |
| COPD, n (%) | 0 (0) | 14 (2) | 0.382 | 0 (0) | 11 (2) | 0.14 |
| IDDM, n (%) | 1 (2) | 6 (1) | 0.512 | 1 (1) | 6 (1) | 0.001 |
| Extracardiac arteriopathy, n (%) | 1 (2) | 11 (2) | 0.612 | 0 (0) | 6 (1) | 0.09 |
| History of chronic renal failure requiring hemodialysis, n (%) | 0 (0) | 1 (0.2) | 1.000 | 0 (0) | 6 (1) | 0.09 |
| Preoperative creatinine value (µmol/l), median (IQR) | 0.97 (0.54–1.4) | 0.97 (0.62–1.32) | 0.076 | 0.94 (0.6–1.28) | 0.98 (0.6–1.36) | 0.10 |
| History of cardiac surgery, n (%) | 6 (10) | 30 (5) | 0.148 | 19 (31) | 217 (33) | 0.002 |
| Connective tissue disease, n (%) | 3 (5) | 59 (10) | 0.173 | 4 (6) | 56 (10) | 0.138 |
| Additional procedures, n (%) | 14 (22) | 147 (25) | 0.449 | 15 (25) | 158 (25) | 0.001 |
| CABG | 0 (0) | 29 (5) | 3 (5) | 0 (0) | ||
| Mitral valve | 2 (3) | 37 (6) | 2 (3) | 34 (6) | ||
| Tricuspid valve | 2 (3) | 8 (1) | 3 (5) | 11 (2) | ||
| MAZE | 4 (6) | 29 (5) | 6 (9) | 28 (5) | ||
| Aortic arch | 0 (0) | 15 (3) | 0 (0) | 17 (3) | ||
| Other | 6 (10) | 29 (5) | 11 (17) | 68 (12) | ||
CABG: coronary artery bypass graft; COPD: chronic obstructive pulmonary disease; IDDM: insulin-dependent diabetes mellitus; IPTW: inverse probability treatment weighting; IQR: interquartile range.
Early postoperative outcomes
Postoperative echocardiography and early surgery-related outcomes before and after propensity score are presented in Table 2. Hospital survival was 100% in the patch group and 98.9% in the no-patch group without significant difference (P = 0.584). The early related valve reoperation rate was more frequent in the patch group as compared to the no-patch group (6% vs 1%, P < 0.001). Seven patients in the patch group were reoperated during hospitalization: 6 of them were treated for recurrent AI (patch dehiscence): 4 underwent an AVR and 2 a new aortic valve repair. The remaining patient underwent a supracoronary ring repositioning for compression of the right coronary (Supplementary Material, Fig. S1). Six patients in the no-patch group were reoperated during hospitalization for recurrent AI: 4 underwent an AVR, 1 patient a new repair for subvalvular dehiscence and 1 a new repair for recurrent AI.
Postoperative echocardiography and early surgery-related outcomes before and after inverse probability treatment weighting in patients treated by aortic valve repair with or without pericardial patch
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
| Postoperative aortic insufficiency, n (%) | 0.046 | 0.009 | ||||
| 0 (none or trivial) | 38 (62) | 380 (72) | 42 (68) | 371 (73) | ||
| I (mild) | 20 (33) | 137 (26) | 17 (27) | 133 (26) | ||
| II (mild to moderate) | 3 (5) | 7 (1) | 3 (5) | 8 (2) | ||
| III (moderate to severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| IV (severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Mean aortic valve gradient, mmHg, median (IQR) | 9.2 (4.8-13.6) | 7.8 (3.9-11.7) | 0.043 | 7.9 (3.9-11.9) | 7.9 (3.9-11.9) | 0.901 |
| Effective height, median (IQR) | 10.2 (7.8-12.6) | 10.7 (7.6-13.2) | 0.667 | 10.2 (8-12.4) | 10.6 (7.8-13.4) | 0.107 |
| Coaptation height, median (IQR) | 8.4 (6.3-10.5) | 8.3 (6.3-10.3) | 0.934 | 8.6 (6.9-10.5) | 8.3 (6.3-10.3) | 0.115 |
| Postoperative LVEF, median (IQR) | 53.8 (41.4-66.2) | 55.1 (46.7-63.5) | 0.662 | 55.9 (44.1-67.7) | 55.4 (45.8-65) | 0.43 |
| Aortic annular base internal diameter (mm), median (IQR) | 22.7 (20.3-25.1) | 22.6 (20.2-25) | 0.899 | 22.7 (20.5-24.9) | 22.7 (20.4-25) | 0.672 |
| Aortic sinus diameter (mm), median (IQR) | 33 (28.3-37.7) | 33.2 (29.4-37) | 0.818 | 32.7 (28.7-26.7) | 33.2 (29.4-37) | 0.14 |
| Sino-tubular junction diameter (mm), median (IQR) | 28.5 (24-33) | 29.5 (25.5-33.5) | 0.483 | 29.4 (25.6-33.2) | 29.5 (25.5-33.5) | 0.109 |
| Aortic ascending tubular diameter (mm), median (IQR) | 31.1 (26.4-35.8) | 31.4 (27.4-35.4) | 0.505 | 31.2 (27.3-35.1) | 31.4 (27.4-35.4) | 0.268 |
| Hospital survival | 100 | 98.4 | 0.786 | 100 | 98.9 | 0.584 |
| Early aortic valve-related reoperation, n (%) | 7 (11) | 6 (1) | <0.001 | 4 (6) | 6 (1) | <0.001 |
| Reoperation for bleeding or tamponade, n (%) | 5 (8) | 25 (4) | 0.198 | 6 (10) | 23 (4) | <0.001 |
| Infection, n (%) | 4 (6) | 38 (7) | 1.000 | 2 (3) | 35 (6) | 0.026 |
| Mediastinitis | 1 (2) | 7 (1) | 0.559 | 1 (1) | 7 (1) | 0.824 |
| Other | 3 (5) | 31 (5) | 1.000 | 2 (3) | 28 (5) | 0.028 |
| Stroke, n (%) | 1 (2) | 3 (0.5) | 0.337 | 1 (1) | 1 (0.2) | 0.233 |
| Acute renal failure, n (%) | 2 (3) | 23 (4) | 1.000 | 2 (3) | 23 (4) | 0.301 |
| Acute respiratory failure, n (%) | 3 (5) | 50 (9) | 0.302 | 4 (6) | 50 (9) | 0.073 |
| Myocardial infarction, n (%) | 3 (5) | 20 (4) | 0.48 | 2 (3) | 20 (3) | 0.789 |
| New pacemaker implantation, n (%) | 1 (2) | 12 (2) | 1.000 | 2 (3) | 11 (2) | 0.212 |
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
| Postoperative aortic insufficiency, n (%) | 0.046 | 0.009 | ||||
| 0 (none or trivial) | 38 (62) | 380 (72) | 42 (68) | 371 (73) | ||
| I (mild) | 20 (33) | 137 (26) | 17 (27) | 133 (26) | ||
| II (mild to moderate) | 3 (5) | 7 (1) | 3 (5) | 8 (2) | ||
| III (moderate to severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| IV (severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Mean aortic valve gradient, mmHg, median (IQR) | 9.2 (4.8-13.6) | 7.8 (3.9-11.7) | 0.043 | 7.9 (3.9-11.9) | 7.9 (3.9-11.9) | 0.901 |
| Effective height, median (IQR) | 10.2 (7.8-12.6) | 10.7 (7.6-13.2) | 0.667 | 10.2 (8-12.4) | 10.6 (7.8-13.4) | 0.107 |
| Coaptation height, median (IQR) | 8.4 (6.3-10.5) | 8.3 (6.3-10.3) | 0.934 | 8.6 (6.9-10.5) | 8.3 (6.3-10.3) | 0.115 |
| Postoperative LVEF, median (IQR) | 53.8 (41.4-66.2) | 55.1 (46.7-63.5) | 0.662 | 55.9 (44.1-67.7) | 55.4 (45.8-65) | 0.43 |
| Aortic annular base internal diameter (mm), median (IQR) | 22.7 (20.3-25.1) | 22.6 (20.2-25) | 0.899 | 22.7 (20.5-24.9) | 22.7 (20.4-25) | 0.672 |
| Aortic sinus diameter (mm), median (IQR) | 33 (28.3-37.7) | 33.2 (29.4-37) | 0.818 | 32.7 (28.7-26.7) | 33.2 (29.4-37) | 0.14 |
| Sino-tubular junction diameter (mm), median (IQR) | 28.5 (24-33) | 29.5 (25.5-33.5) | 0.483 | 29.4 (25.6-33.2) | 29.5 (25.5-33.5) | 0.109 |
| Aortic ascending tubular diameter (mm), median (IQR) | 31.1 (26.4-35.8) | 31.4 (27.4-35.4) | 0.505 | 31.2 (27.3-35.1) | 31.4 (27.4-35.4) | 0.268 |
| Hospital survival | 100 | 98.4 | 0.786 | 100 | 98.9 | 0.584 |
| Early aortic valve-related reoperation, n (%) | 7 (11) | 6 (1) | <0.001 | 4 (6) | 6 (1) | <0.001 |
| Reoperation for bleeding or tamponade, n (%) | 5 (8) | 25 (4) | 0.198 | 6 (10) | 23 (4) | <0.001 |
| Infection, n (%) | 4 (6) | 38 (7) | 1.000 | 2 (3) | 35 (6) | 0.026 |
| Mediastinitis | 1 (2) | 7 (1) | 0.559 | 1 (1) | 7 (1) | 0.824 |
| Other | 3 (5) | 31 (5) | 1.000 | 2 (3) | 28 (5) | 0.028 |
| Stroke, n (%) | 1 (2) | 3 (0.5) | 0.337 | 1 (1) | 1 (0.2) | 0.233 |
| Acute renal failure, n (%) | 2 (3) | 23 (4) | 1.000 | 2 (3) | 23 (4) | 0.301 |
| Acute respiratory failure, n (%) | 3 (5) | 50 (9) | 0.302 | 4 (6) | 50 (9) | 0.073 |
| Myocardial infarction, n (%) | 3 (5) | 20 (4) | 0.48 | 2 (3) | 20 (3) | 0.789 |
| New pacemaker implantation, n (%) | 1 (2) | 12 (2) | 1.000 | 2 (3) | 11 (2) | 0.212 |
IPTW: inverse probability treatment weighting; IQR: interquartile range; LVEF: left ventricular ejection fraction; OR: Odds Ratio; HR; Heart Rythm; NYHA; New York Heart Association
Postoperative echocardiography and early surgery-related outcomes before and after inverse probability treatment weighting in patients treated by aortic valve repair with or without pericardial patch
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
| Postoperative aortic insufficiency, n (%) | 0.046 | 0.009 | ||||
| 0 (none or trivial) | 38 (62) | 380 (72) | 42 (68) | 371 (73) | ||
| I (mild) | 20 (33) | 137 (26) | 17 (27) | 133 (26) | ||
| II (mild to moderate) | 3 (5) | 7 (1) | 3 (5) | 8 (2) | ||
| III (moderate to severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| IV (severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Mean aortic valve gradient, mmHg, median (IQR) | 9.2 (4.8-13.6) | 7.8 (3.9-11.7) | 0.043 | 7.9 (3.9-11.9) | 7.9 (3.9-11.9) | 0.901 |
| Effective height, median (IQR) | 10.2 (7.8-12.6) | 10.7 (7.6-13.2) | 0.667 | 10.2 (8-12.4) | 10.6 (7.8-13.4) | 0.107 |
| Coaptation height, median (IQR) | 8.4 (6.3-10.5) | 8.3 (6.3-10.3) | 0.934 | 8.6 (6.9-10.5) | 8.3 (6.3-10.3) | 0.115 |
| Postoperative LVEF, median (IQR) | 53.8 (41.4-66.2) | 55.1 (46.7-63.5) | 0.662 | 55.9 (44.1-67.7) | 55.4 (45.8-65) | 0.43 |
| Aortic annular base internal diameter (mm), median (IQR) | 22.7 (20.3-25.1) | 22.6 (20.2-25) | 0.899 | 22.7 (20.5-24.9) | 22.7 (20.4-25) | 0.672 |
| Aortic sinus diameter (mm), median (IQR) | 33 (28.3-37.7) | 33.2 (29.4-37) | 0.818 | 32.7 (28.7-26.7) | 33.2 (29.4-37) | 0.14 |
| Sino-tubular junction diameter (mm), median (IQR) | 28.5 (24-33) | 29.5 (25.5-33.5) | 0.483 | 29.4 (25.6-33.2) | 29.5 (25.5-33.5) | 0.109 |
| Aortic ascending tubular diameter (mm), median (IQR) | 31.1 (26.4-35.8) | 31.4 (27.4-35.4) | 0.505 | 31.2 (27.3-35.1) | 31.4 (27.4-35.4) | 0.268 |
| Hospital survival | 100 | 98.4 | 0.786 | 100 | 98.9 | 0.584 |
| Early aortic valve-related reoperation, n (%) | 7 (11) | 6 (1) | <0.001 | 4 (6) | 6 (1) | <0.001 |
| Reoperation for bleeding or tamponade, n (%) | 5 (8) | 25 (4) | 0.198 | 6 (10) | 23 (4) | <0.001 |
| Infection, n (%) | 4 (6) | 38 (7) | 1.000 | 2 (3) | 35 (6) | 0.026 |
| Mediastinitis | 1 (2) | 7 (1) | 0.559 | 1 (1) | 7 (1) | 0.824 |
| Other | 3 (5) | 31 (5) | 1.000 | 2 (3) | 28 (5) | 0.028 |
| Stroke, n (%) | 1 (2) | 3 (0.5) | 0.337 | 1 (1) | 1 (0.2) | 0.233 |
| Acute renal failure, n (%) | 2 (3) | 23 (4) | 1.000 | 2 (3) | 23 (4) | 0.301 |
| Acute respiratory failure, n (%) | 3 (5) | 50 (9) | 0.302 | 4 (6) | 50 (9) | 0.073 |
| Myocardial infarction, n (%) | 3 (5) | 20 (4) | 0.48 | 2 (3) | 20 (3) | 0.789 |
| New pacemaker implantation, n (%) | 1 (2) | 12 (2) | 1.000 | 2 (3) | 11 (2) | 0.212 |
| Before IPTW | After IPTW | |||||
|---|---|---|---|---|---|---|
| Patch group, n = 63 (%) | No-patch group, n = 580 (%) | P-Value | Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
| Postoperative aortic insufficiency, n (%) | 0.046 | 0.009 | ||||
| 0 (none or trivial) | 38 (62) | 380 (72) | 42 (68) | 371 (73) | ||
| I (mild) | 20 (33) | 137 (26) | 17 (27) | 133 (26) | ||
| II (mild to moderate) | 3 (5) | 7 (1) | 3 (5) | 8 (2) | ||
| III (moderate to severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| IV (severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Mean aortic valve gradient, mmHg, median (IQR) | 9.2 (4.8-13.6) | 7.8 (3.9-11.7) | 0.043 | 7.9 (3.9-11.9) | 7.9 (3.9-11.9) | 0.901 |
| Effective height, median (IQR) | 10.2 (7.8-12.6) | 10.7 (7.6-13.2) | 0.667 | 10.2 (8-12.4) | 10.6 (7.8-13.4) | 0.107 |
| Coaptation height, median (IQR) | 8.4 (6.3-10.5) | 8.3 (6.3-10.3) | 0.934 | 8.6 (6.9-10.5) | 8.3 (6.3-10.3) | 0.115 |
| Postoperative LVEF, median (IQR) | 53.8 (41.4-66.2) | 55.1 (46.7-63.5) | 0.662 | 55.9 (44.1-67.7) | 55.4 (45.8-65) | 0.43 |
| Aortic annular base internal diameter (mm), median (IQR) | 22.7 (20.3-25.1) | 22.6 (20.2-25) | 0.899 | 22.7 (20.5-24.9) | 22.7 (20.4-25) | 0.672 |
| Aortic sinus diameter (mm), median (IQR) | 33 (28.3-37.7) | 33.2 (29.4-37) | 0.818 | 32.7 (28.7-26.7) | 33.2 (29.4-37) | 0.14 |
| Sino-tubular junction diameter (mm), median (IQR) | 28.5 (24-33) | 29.5 (25.5-33.5) | 0.483 | 29.4 (25.6-33.2) | 29.5 (25.5-33.5) | 0.109 |
| Aortic ascending tubular diameter (mm), median (IQR) | 31.1 (26.4-35.8) | 31.4 (27.4-35.4) | 0.505 | 31.2 (27.3-35.1) | 31.4 (27.4-35.4) | 0.268 |
| Hospital survival | 100 | 98.4 | 0.786 | 100 | 98.9 | 0.584 |
| Early aortic valve-related reoperation, n (%) | 7 (11) | 6 (1) | <0.001 | 4 (6) | 6 (1) | <0.001 |
| Reoperation for bleeding or tamponade, n (%) | 5 (8) | 25 (4) | 0.198 | 6 (10) | 23 (4) | <0.001 |
| Infection, n (%) | 4 (6) | 38 (7) | 1.000 | 2 (3) | 35 (6) | 0.026 |
| Mediastinitis | 1 (2) | 7 (1) | 0.559 | 1 (1) | 7 (1) | 0.824 |
| Other | 3 (5) | 31 (5) | 1.000 | 2 (3) | 28 (5) | 0.028 |
| Stroke, n (%) | 1 (2) | 3 (0.5) | 0.337 | 1 (1) | 1 (0.2) | 0.233 |
| Acute renal failure, n (%) | 2 (3) | 23 (4) | 1.000 | 2 (3) | 23 (4) | 0.301 |
| Acute respiratory failure, n (%) | 3 (5) | 50 (9) | 0.302 | 4 (6) | 50 (9) | 0.073 |
| Myocardial infarction, n (%) | 3 (5) | 20 (4) | 0.48 | 2 (3) | 20 (3) | 0.789 |
| New pacemaker implantation, n (%) | 1 (2) | 12 (2) | 1.000 | 2 (3) | 11 (2) | 0.212 |
IPTW: inverse probability treatment weighting; IQR: interquartile range; LVEF: left ventricular ejection fraction; OR: Odds Ratio; HR; Heart Rythm; NYHA; New York Heart Association
Survival and reoperation during follow-up
The 8-year survival rate in the IPTW population was 92% in the patch group and 90.2% in the no-patch group without significant difference (P = 0.957) (Supplementary Material, Fig. S2). Mid-term survival comparison analysis showed no significant difference between the 2 groups in the entire cohort (90.8% in the patch group and 90.2% in the no-patch group, P = 0.867) (Supplementary Material, Fig. S3).
In the IPTW population, freedom from aortic valve-related reintervention at 8 years was 93.7% in the patch group and 94% in the no-patch group without significant difference (P = 0.968) (Fig. 1). In the entire cohort, freedom from aortic valve-related reintervention at 8 years was lower in the patch group as compared to the no-patch group (83.3% vs 93%, P = 0.001) (Supplementary Material, Fig. S4).
Kaplan–Meier freedom from aortic valve-related reintervention estimate in the inverse probability treatment weighting population treated by aortic valve repair with or without pericardial patch.
Risk factors associated with reoperation according to multivariable Cox model analysis were postoperative mean aortic valve gradient (per 1-mmHg increase) [OR = 1.21 confidence interval (CI) [1.046–1.4], P = 0.01] and postoperative AI ≥ I (mild) (OR = 4.034 CI [1.449–11.23], P = 0.008). Postoperative effective height (per 1-mm increase) (OR = 0.639 CI [0.419–0.975], P = 0.038) was an independent protector factor of reoperation (Supplementary Material, Table S3). Regarding the number of cusps, valve-related 8-year freedom from reoperation was 88.9% for unicuspid valve, 95.2% for bicuspid valve and 93.7% for tricuspid valve without significant difference (P = 0.697) (Supplementary Material, Fig. S5). No patient treated with cusp nadir reconstruction or cusp extension or commissural reconstruction was reoperated at last follow-up. Only 1 patient in the patch group was reoperated at the last follow-up. This patient was operated on for an aortic root aneurysm with an AI grade III (tricuspid valve). We performed a root remodelling reconstruction with fenestration reconstruction using an autologous pericardial patch. Mid-term aortic valve-related reintervention details are presented in Supplementary Material, Table S4.
Structural valve deterioration
Freedom from SVD at 8-year in IPTW population was 99.3% in the patch group and 96.7% in the no-patch group without significant difference (P = 0.964) (Fig. 2). Freedom from AI ≥ III at 8-year in the IPTW population was 99.3% in the patch group and 96.7% in the no-patch group without significant difference (P = 0.964) (Fig. 3A). Freedom from AI ≥ II at 8 years in IPTW population was significantly lower in the patch group as compared to the no-patch group (56.6% vs 80.3%, P = 0.02) (Fig. 3B). Regarding the number of cusps, freedom from SVD at 8-year was 100% for unicuspid valve, 93.9% for bicuspid valve and 97.3% for tricuspid valve without significant difference (P = 0.68) (Supplementary Material, Fig. S6). Freedom from mean aortic valve gradient ≥20 and <40 mmHg at 8 years in IPTW population was significantly lower in the patch group as compared to the no-patch group (75% vs 81.8%, P = 0.047). Summary of 8-year Kaplan–Meier estimates of freedom from main clinical and echocardiography events data after IPTW in patients treated by aortic valve repair with or without pericardial patch are presented in Table 3.
Kaplan–Meier freedom from structural valve deterioration estimate in the inverse probability treatment weighting population treated by aortic valve repair with or without pericardial patch. SVD: structural valve deterioration.
Kaplan–Meier freedom from aortic insufficiency ≥ III (A) and aortic insufficiency ≥ II (Structural valve deterioration) estimate in the inverse probability treatment weighting population treated by aortic valve repair with or without pericardial patch.
Valve-sparing root replacement according to the remodelling with a subvalvular annuloplasty and implantation of a pericardial patch to correct a fenestration rupture. See Supplementary Material for video legend.
Summary of 8-year Kaplan–Meier estimates of freedom from main clinical and echocardiography events data after inverse probability of treatment weighting in patients treated by aortic valve repair with or without pericardial patch
| Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
|---|---|---|---|
| AI | |||
| Freedom from AI ≥ I (mild) | 14.7 | 36 | <0.001 |
| Freedom from AI ≥ II (mild to moderate) | 56.6 | 80.3 | 0.02 |
| Freedom from AI ≥ III (moderate to severe) | 99.3 | 96.7 | 0.964 |
| Freedom from AI ≥ IV (severe) | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥40 mmHg | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥20 and <40 mmHg | 75 | 81.1 | 0.047 |
| Freedom from severe structural valve deterioration | 99.3 | 96.7 | 0.964 |
| Freedom from aortic valve related reintervention | 93.7 | 94 | 0.968 |
| Survival | |||
| Freedom from infective endocarditis | 100 | 99.2 | 0.587 |
| Freedom from aortic valve thrombosis | 100 | 100 | >0.99 |
| Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
|---|---|---|---|
| AI | |||
| Freedom from AI ≥ I (mild) | 14.7 | 36 | <0.001 |
| Freedom from AI ≥ II (mild to moderate) | 56.6 | 80.3 | 0.02 |
| Freedom from AI ≥ III (moderate to severe) | 99.3 | 96.7 | 0.964 |
| Freedom from AI ≥ IV (severe) | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥40 mmHg | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥20 and <40 mmHg | 75 | 81.1 | 0.047 |
| Freedom from severe structural valve deterioration | 99.3 | 96.7 | 0.964 |
| Freedom from aortic valve related reintervention | 93.7 | 94 | 0.968 |
| Survival | |||
| Freedom from infective endocarditis | 100 | 99.2 | 0.587 |
| Freedom from aortic valve thrombosis | 100 | 100 | >0.99 |
AI: aortic insufficiency.
Summary of 8-year Kaplan–Meier estimates of freedom from main clinical and echocardiography events data after inverse probability of treatment weighting in patients treated by aortic valve repair with or without pericardial patch
| Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
|---|---|---|---|
| AI | |||
| Freedom from AI ≥ I (mild) | 14.7 | 36 | <0.001 |
| Freedom from AI ≥ II (mild to moderate) | 56.6 | 80.3 | 0.02 |
| Freedom from AI ≥ III (moderate to severe) | 99.3 | 96.7 | 0.964 |
| Freedom from AI ≥ IV (severe) | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥40 mmHg | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥20 and <40 mmHg | 75 | 81.1 | 0.047 |
| Freedom from severe structural valve deterioration | 99.3 | 96.7 | 0.964 |
| Freedom from aortic valve related reintervention | 93.7 | 94 | 0.968 |
| Survival | |||
| Freedom from infective endocarditis | 100 | 99.2 | 0.587 |
| Freedom from aortic valve thrombosis | 100 | 100 | >0.99 |
| Patch group, n = 62 (%) | No-patch group, n = 565 (%) | P-Value | |
|---|---|---|---|
| AI | |||
| Freedom from AI ≥ I (mild) | 14.7 | 36 | <0.001 |
| Freedom from AI ≥ II (mild to moderate) | 56.6 | 80.3 | 0.02 |
| Freedom from AI ≥ III (moderate to severe) | 99.3 | 96.7 | 0.964 |
| Freedom from AI ≥ IV (severe) | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥40 mmHg | 100 | 100 | >0.99 |
| Freedom from mean aortic valve gradient ≥20 and <40 mmHg | 75 | 81.1 | 0.047 |
| Freedom from severe structural valve deterioration | 99.3 | 96.7 | 0.964 |
| Freedom from aortic valve related reintervention | 93.7 | 94 | 0.968 |
| Survival | |||
| Freedom from infective endocarditis | 100 | 99.2 | 0.587 |
| Freedom from aortic valve thrombosis | 100 | 100 | >0.99 |
AI: aortic insufficiency.
Infective endocarditis and thrombosis
Eight-year freedom from infective endocarditis in the IPTW population was 100% in the patch group and 99.2% in the no-patch group (P = 0.587) (Supplementary Material, Fig. S7). In the entire cohort, no significant difference in freedom from infective endocarditis at 8 years between the 2 groups was noted (100% in the patch group and 99.2% in the no-patch group, P = 0.902). No valve thrombosis was noted during follow-up in the entire cohort.
DISCUSSION
Aortic valvuloplasty is increasingly used to treat isolated AI or associated with an aortic root aneurysm or a tubular aortic aneurysm. It became the gold standard for type I or II mechanism of AR in expert centers [4]. However, when complex aortic valve lesions require additional material to restore the valvular function, many surgeons prefer to switch from aortic valvuloplasty to AVR or the Ross procedure regarding disappointing mid-term outcomes of the pericardial patch, which has been identified as a risk factor of reoperation [18]. To our knowledge, this is the first study analysing outcomes of aortic valve repair using pericardial patch in a standardized approach of aortic valve repair such as valve-sparing root replacement according to the remodelling root repair with an external subvalvular annuloplasty or double sub- and supracoronary external aortic annuloplasty. Although early valve-related reoperations were more frequent with the use of the pericardial patch in this study, freedom from aortic valve-related reintervention and freedom from SVD at 8 years were not increased compared to the no-patch group. For both groups, postoperative mean aortic valve gradient (per 1-mmHg increase) and postoperative AI ≥ I were independent risk factors of mid-term aortic valve-related reintervention, postoperative effective height (per 1-mm increase) was an independent protector factor of mid-term aortic valve-related reintervention and pericardial patch was not a risk factor of reoperation.
Postoperative grade II AI and early related valve reoperation rate were more frequent in the patch group as compared to the no-patch group (5% vs 2%, P = 0.009, and 6% vs 1%, P < 0.001, respectively). It underlines the fact that aortic valvuloplasty techniques using the pericardial patch are more challenging (commissural reconstruction above all). Indeed, among the 7 patients re-operated for residual grade II AI in the patch group, 5 of them underwent unicuspid valve repair by commissural reconstruction (Supplementary Material, Fig. S1). However, despite higher early related valve reoperation rate and longer cross-clamp times, aortic valvuloplasty using the pericardial patch did not result in excess mortality or surgery-related complications compared to valvuloplasty without the use of pericardial patch (Table 3). Moreover, the incidence of myocardial infarction is roughly 3% in both groups, it can be explained mainly because the coronary ostia and their proximal segments are mobilized/reimplanted and thus can be injured in case of valve-sparing root replacement with aortic valve repair.
The mean result of this study was that the use of the pericardial patch was not associated with mid-term aortic valve-related reoperation after aortic valve repair standardized with external ring annuloplasty when compared to cusp repair without the use of the pericardial patch. This finding contrasts with the results of other studies focusing on the durability of aortic valve repair using the pericardial patch [19–21]. Diana et al. [20] found that the use of a pericardial patch had a negative effect on repair durability and was an independent risk factor for reoperation (HR = 5.16 CI [2.100–12.753], P < 0.001). Karliova et al. [19] found that 10-year freedom from reoperation was 73% for fenestrations repair, 67% for defects repair, 44% for cusp augmentation (44%), 39% for central cusp replacement (39%) and 16% for commissural reconstruction (P = 0.001). This could be explained by the fact that annuloplasty was performed in only 1 quarter of the patients in these studies, whereas a standardized approach of aortic valve repair with the systematic adjunct of an external annuloplasty was applied according to the aorta phenotype using a double sub- and supracoronary aortic annuloplasty for isolated AI, or a subvalvular annuloplasty for AI associated with a tubular aortic aneurysm or aortic root aneurysm (see Table 2). In fact, in our study, no patient treated with cusp nadir reconstruction or cusp extension or commissural reconstruction was reoperated at the last follow-up. Only 1 patient from the patch group was reoperated at the distance of the surgery. Thus, the quality of aortic valve repair in the long term could depend on technical standardization [22] with the systematic adjunct of an external annuloplasty [23], absence of postoperative AI > I, low postoperative mean aortic valve gradient and good effective height. Moreover, even if freedom from AI ≥ III at 8 years in the IPTW population was 99.3% in the patch group and 96.7% in the no-patch group without significant difference (P = 0.964), the significant appearance of AI grade II and increased mean aortic valve gradient in the patch group might be related to retraction scaring process of the pericardial patch. The question remains whether it represents a risk of reoperation or death on longer-term follow-up than 8 years. Finally, in the case of the unrepairable aortic valve (too retracted or too large fenestration), 2 alternatives can be discussed: aortic valve neocuspidization using glutaraldehyde-treated autologous pericardium which showed excellent midterm clinical and haemodynamic outcomes; and the Ross procedure. No studies directly compared aortic valve repair with the pericardial patch and the Ross procedure in young adults. In children, Danial et al. [15] showed that in patients aged under 18 treated for complex aortic valve lesions (aortic stenosis and/or insufficiency), aortic valvuloplasty using a pericardial patch is a reliable method resulting in similar freedom from reintervention and 8-year survival compared to the Ross procedure. Aortic valvuloplasty tended to be associated with fewer cases of infective endocarditis at 8 years, and the early postoperative outcome was in favour of aortic valve repair. Moreover, aortic valvuloplasty avoids transforming a univalvular pathology into a bi-valvular pathology.
Limitations
This study has certain limitations. First, all procedures were substantially under the proctorship of Dr Lansac. This fact probably limits surgical bias, but external validation may be an issue. Moreover, longer-term follow-up (over 8 years) is needed to assess the efficiency and durability of aortic valve repair using the pericardial patch.
CONCLUSION
In conclusion, although a higher rate of early reintervention was observed due to the complexity of the repair, the present study shows that aortic valve repair using the pericardial patch, in a standardized approach using external annuloplasty, with effective coaptation height of at least 9 mm, was not associated with an increase in mid-term aortic valve-related reoperation or SVD as compared to valve repair without the use of the pericardial patch. These results are encouraging to extend indications of aortic valve repair including cusp reconstruction, particularly in young patients.
SUPPLEMENTARY MATERIAL
Supplementary material is available at EJCTS online.
Conflictof interest: Emmanuel Lansac has consultant agreements with CORONEO, Inc (www.coroneo.com). The other authors report no conflicts of interest.
Data Availability Statement
The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study. The data will be shared on reasonable request to the corresponding author.
Author contributions
Pichoy Danial: Conceptualization; Data curation; Formal analysis; Methodology; Validation; Writing—original draft; Writing—review & editing. Alexander Moiroux-Sahraoui: Conceptualization; Data curation; Validation. Mathieu Debauchez: Conceptualization; Methodology; Validation; Writing—review & editing. Jean-Luc Monin: Conceptualization; Methodology; Validation; Writing—review & editing. Alain Berrebi: Conceptualization; Methodology; Validation; Writing—review & editing. Nathanael Shraer: Conceptualization; Data curation; Formal analysis; Validation; Writing—review & editing. Emmanuel Lansac: Conceptualization; Methodology; Supervision; Validation; Writing—review & editing.
Reviewer information
European Journal of Cardio-Thoracic Surgery thanks Mirko Doss and the other, anonymous reviewer(s) for their contribution to the peer review process of this article.
REFERENCES
ABBREVIATIONS
- AI
Aortic insufficiency
- AVR
Aortic valve replacement
- IPTW
Inverse probability of treatment weighting
- SVD
Structural valve deterioration
