Outcomes of aortic valve-sparing root replacement with cusp repair in connective tissue disease.

BACKGROUND: Although, valve sparing is commonly performed in patients with Marfan syndrome, feasibility and results of cusp repair for aortic insufficiency have not been studied. AIM: To report on the outcomes and durability of aortic cusp repair in valve sparing in patients with Marfan syndrome. METHODS: All consecutive adult patients with Marfan syndrome who underwent remodelling and annuloplasty with aortic valve repair for aortic insufficiency between May 2005 and December 2020 were included. Patients with Marfan syndrome treated for aortic aneurysm, but without aortic insufficiency, were excluded. Data were collected prospectively and reviewed retrospectively from the Aorticvalve repair International Registry (AVIATOR). RESULTS: During the study period, 71 patients with Marfan syndrome were referred to surgery. Fifty-five patients with connective tissue disease and aortic insufficiency with aorta aneurysm were treated: 46 underwent aortic valve repair and nine underwent aortic valve replacement (five mechanical aortic valve replacements and four biological aortic valve replacements). The mean age was 42.9±15.4 years, and the mean EuroScore II was 2.5±2.2. No patient died, and no patient had significant aortic insufficiency (grade≥II) at discharge. The 5-year survival rate estimate was 94.4%, which seems statistically similar to that of the age- and sex-matched general population. At 5 years, freedom from reoperation was 94.6%, and the incidence of infective endocarditis was 2.6%. No valve thrombosis, aortic dissection, major bleeding events, thromboembolic events (stroke) or myocardial infarctions were noted during follow-up. CONCLUSION: Remodelling and aortic valve repair showed excellent durability at 5 years, even in connective tissue disorders.

Bicuspid valve repair outcomes are improved with reduction and stabilization of sinotubular junction and annulus with external annuloplasty.

OBJECTIVE: We investigated long-term outcomes of bicuspid aortic valve (BAV) repair, with external annuloplasty, according to aorta phenotype. METHODS: Between 2003 and 2020, all patients with BAV operated on for aortic insufficiency (AI) and/or aneurysm were included. Repairs included isolated AI repair with subvalvular with or without sinotubular junction (STJ) (single or double) annuloplasty, supracoronary aorta replacement (with or without hemiroot remodeling), and root remodeling with external subvalvular ring annuloplasty. RESULTS: Among 343 patients operated, reparability rate was 81.3% (n = 279; age 46 ± 13.3 years). At 10 years (median follow-up: 3.42 years; interquartile range, 1.1, 5.8), survival was 93.9% (n = 8 deaths, similar to general population), cumulative incidence of reoperation was 6.2% (n = 10), AI grade >2 was 5.8% (n = 9), and grade >1 was 23.0% (n = 30). BAV repair stabilizing both the annulus and STJ with annuloplasty, compared with nonstabilized STJ repair (single annuloplasty), had lower incidence of reoperation (2.6% vs 22.5%, P = .0018) and AI grade >2 (1.2% vs 23.6%, P < .001) at 9 years. Initial commissural angle <160° was not a risk factor for reoperation, compared with angle ≥160° if symmetrical repair was achieved (2.7% and 4.1%, respectively, at 6 years, P = .85). Multivariable model showed that absence of STJ stabilization (odds ratio, 6.7; 95% confidence interval, 2.1-20, P = .001) increased recurrent AI, but not initial commissural angle <160° (odds ratio, 1.01; 95% confidence interval, 0.39-2.63, P = .98). Commissures adjusted symmetrically led to lower transvalvular gradient, compared with nonsymmetrical repair (8.7 mm Hg vs 10.2 mm Hg, P = .029). CONCLUSIONS: BAV repair, tailored to aorta phenotype, is associated with excellent durable outcomes if both annulus and STJ are reduced and stabilized with external ring annuloplasty. Commissural angle <160° is not associated with reoperation if symmetrical repair is achieved.

Aortic valve repair versus mechanical valve replacement for root aneurysm: the CAVIAAR multicentric study.

OBJECTIVES: Despite growing evidence that aortic valve repair improves long-term patient outcomes and quality of life, aortic valves are mostly replaced. We evaluate the effect of aortic valve repair versus replacement in patients with dystrophic aortic root aneurysm up to 4 years. METHODS: The multicentric CAVIAAR (Conservation Aortique Valvulaire dans les Insuffisances Aortiques et les Anévrismes de la Racine aortique) prospective cohort study enrolled 261 patients: 130 underwent standardized aortic valve repair (REPAIR) consisting of remodelling root repair with expansible aortic ring annuloplasty, and 131 received mechanical composite valve and graft replacement (REPLACE). Primary outcome was a composite criterion of mortality, reoperation, thromboembolic or major bleeding events, endocarditis or operating site infections, pacemaker implantation and heart failure, analysed with propensity score-weighted Cox model analysis. Secondary outcomes included major adverse valve-related events and components of primary outcome. RESULTS: The mean age was 56.1 years, and valve was bicuspid in 115 patients (44.7%). Up to 4 years, REPAIR did not significantly differ from REPLACE in terms of primary outcome [Hazard Ratio (HR) 0.66 (0.39; 1.12)] but showed significantly less valve-related deaths (HR 0.09 [0.02; 0.34]) and major bleeding events (HR 0.37 [0.16; 0.85]) without an increased risk of valve-related reoperation (HR 2.10 [0.64; 6.96]). When accounting for the occurrence of multiple events in a single patient, the REPAIR group had half the occurrence of major adverse valve-related events (HR 0.51 [0.31; 0.86]). CONCLUSIONS: Although the primary outcome did not significantly differ between the REPAIR and REPLACE groups, the trend is in favour of REPAIR by a significant reduction of valve-related deaths and major bleeding events. Long-term follow-up beyond 4 years is needed to confirm these findings.

Aortic valve fenestration: respect it or fix it?

OBJECTIVES: We investigated whether aortic valve fenestrations (respected or fixed) represent a factor associated with recurrent aortic insufficiency or reoperation after repair. METHODS: Between 2003 and 2019, patients who underwent aortic valve repair were included. Aortic insufficiency phenotypes were root aneurysm (repair: root remodelling + annuloplasty), ascending aorta aneurysm (repair: tubular aortic replacement + annuloplasty) and isolated regurgitation (repair: single/double annuloplasty). Fenestrations were either respected or fixed according to their features. RESULTS: A total of 618 patients (out of 798 operated on; 77.4%) had their valve repaired, with 167 cases of fenestrations (128 were respected, 39 fixed-32 with a patch, 6 with running suture and 1 with both). After conducting propensity score matching between no-fenestration (n = 167) and fenestration groups (n = 167), respectively, we noted the following: survival [90.3% (n = 7 deaths) vs 95.8% (n = 4)], cumulative incidence of reoperation [6.7% (n = 7) vs 5.2% (n = 4)], aortic insufficiency grade ≥ 3 [6.4% (n = 6) vs 4.4% (n = 4)] and grade ≥ 2 [28.9% (n = 28) vs 37.1% (n = 35)] were similar at 9 years [P = 0.94; median follow-up: 2.2, interquartile range: (0.8, 5.8)], whether fenestration was respected (P = 0.55) or fixed (P = 0.6, at 6 years). Standardization of the surgical approach (consisting of double annuloplasty in isolated regurgitation phenotype and expansible subvalvular annuloplasty with effective height assessment with remodelling repair for root aneurysm phenotype) reduced the risk of reoperation (era before standardization: hazard ratio: 5.4, 95% confidence interval: 1.9-15.7, P = 0.002). CONCLUSIONS: Fenestration, respected or fixed, is not a factor associated with reoperation or recurrence of significant aortic insufficiency after valve repair if the surgical approach is standardized.

Aortic valve repair using pericardial patch standardized with external ring annuloplasty.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Root repair with aortic ring annuloplasty using the standard approach.

Standardization of aortic valve repair techniques with use of a calibrated annuloplasty have led to improved long-term outcomes in dystrophic aortic insufficiency. It can also improve dissemination of techniques and rates of aortic valve repair. Dystrophic aortic insufficiency can be found in three aortic phenotypes: dilated aortic root, dilated ascending aorta and isolated aortic insufficiency. The aortic annulus is invariably dilated above 25 mm in the vast majority of cases of aortic insufficiency, regardless of whether the aorta is dilated or not. A dilated annulus is a risk factor for late failure of aortic valve repair if not addressed at the time of surgery. We perform a calibrated annuloplasty at both sub- and supra-valvular levels in order to restore the ratio of sinotubular junction and annulus. Current evidence shows aortic valve repair reduces valve-related mortality compared to prosthetic valve replacement, with an improved quality of life.

Early exercise training feasibility after aortic valve repair: A multicentre prospective French survey on behalf of the Aortic Valve repair International Registry (AVIATOR).

BACKGROUND: Standardization of aortic valve repair by the external ring annuloplasty approach is an alternative to valve replacement to avoid prosthetic valve-related events. Although the benefit of exercise training to improve postoperative exercise tolerance has been demonstrated in many conditions after cardiac surgery, it has never been described after aortic valve repair. OBJECTIVES: To evaluate the feasibility of an early exercise training programme after aortic valve repair. METHODS: Consecutive patients were prospectively included in 13 postoperative centres. Patients underwent an exercise training programme for approximately 3-5 weeks. Transthoracic echocardiography and a cardiopulmonary exercise test were performed before and after the exercise training programme. RESULTS: Fifty patients (mean±standard deviation [SD] age: 50±13 years) were included a mean of 13.6±12.0 days after aortic valve repair. The preoperative degree of aortic insufficiency was moderate to severe in 35 patients (70%) and the aortic valve was bicuspid in 24 patients (48%). Valve-sparing root replacement and isolated aortic valve repair (including 10% supracoronary aorta replacement) were performed in 64% and 36% of patients, respectively. We found no aortic insufficiency occurrence or worsening and no adverse clinical events after the exercise training programme. Mean left ventricular ejection fraction increased significantly (from 54%±8% to 57%±9%; P=0.0007). Mean peak oxygen consumption and first ventilatory threshold increased from 17.0±5.3 to 22.5±7.8mL/kg/min (32% increase) and from 12.0±3.9 to 14.3±5.2mL/kg/min (19% increase), respectively (both P<0.05). CONCLUSION: Exercise training early after aortic valve repair is safe and seems to significantly improve exercise capacity.

Isolated aortic insufficiency valve repair with external ring annuloplasty: a standardized approach.

OBJECTIVES: Aortic valve (AV) insufficiency with normal root and ascending aorta is most frequently treated by valve replacement with significant prosthetic-related complications and reduced life expectancy. We compared the outcomes of a new standardized isolated AV repair approach using an external aortic annuloplasty ring at the subvalvular level (single ring annuloplasty) and the role of an additional supravalvular ring at the sinotubular junction (double ring annuloplasty). METHODS: Single centre data were collected from the Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry (AVIATOR) between 2003 and 2017. A total of 93 patients (56 single ring and 37 double ring) underwent isolated AV repair. RESULTS: The overall 30-day mortality rate and the need for a permanent pacemaker were 1% and 2%, respectively. The overall survival rate at 6 years was similar for sex- and age-matched members of the general population (89% vs 95%; P = 0.1) and did not differ between the double and single ring groups (82% vs 93%; P = 0.4) at 6 years. There were no thromboembolic or bleeding events in the entire cohort. However, at 6 years, the cumulative incidence of valve-related reintervention was 26% in the single ring annuloplasty group compared to 3% in the double ring annuloplasty (P = 0.02) group. Similarly, at 6 years, the cumulative incidence of moderate-to-severe (>2) aortic insufficiency was 30% in the single ring annuloplasty group compared to 0% in the double ring annuloplasty group (P = 0.007). CONCLUSIONS: Standardized AV repair with external ring annuloplasty has a survival rate similar to that of the general population. The additional stabilization of the sinotubular junction with a second supravalvular ring (double ring annuloplasty) is associated with better outcomes compared to single subvalvular annuloplasty. It can be considered as a first line intervention for patients with isolated aortic insufficiency and pliable leaflets.

Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol.

INTRODUCTION: Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences.Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG-70% isopropanol is more effective than 5% PVI-69% ethanol in reducing the incidence of reoperation after cardiac surgery. METHODS AND ANALYSIS: The CLEAN 2 study is a multicentre, open-label, randomised, controlled clinical trial of 4100 patients undergoing cardiac surgery. Patients will be randomised in 1:1 ratio to receive either 2% CHG-70% isopropanol or 5% PVI-69% ethanol for perioperative skin preparation. The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery. Data will be analysed on the intention-to-treat principle. ETHICS AND DISSEMINATION: This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2017-005169-33 and NCT03560193.

Bicuspid aortic valve repair adapted to aortic phenotype.

The bicuspid aortic valve (BAV) is the most common congenital cardiovascular anomaly and may present with differing phenotypes including almost constant annular dilation. We have developed a standardized approach to BAV repair with a systematic adjunct of aortic annuloplasty according to the three phenotypes of the proximal aorta, which include a dilated aortic root, dilated ascending aorta and normal root and ascending aorta. In our cohort of 191 patients, freedom from AV-related re-intervention was 98% for remodeling with annuloplasty (n=100) and 100% for tubular aortic replacement with annuloplasty (n=31) at 8 years. In an isolated aortic insufficiency (AI) group, freedom from AV-related re-intervention varied from 72.4% with a single subvalvular annuloplasty ring (n=31) compared to 100% at 6 years when a double sub- and supra-valvular (STJ) annuloplasty ring was performed (n=29). Restoration of the annulus: sinotubular junction (STJ) ratio is a key factor to ensure longevity of the bicuspid valve repair and freedom from re-intervention.

Mitroflow LXA structural deterioration following aortic valve replacement: a single-center experience.

BACKGROUND: Concerns have been previously raised regarding the potential early degeneration of the Mitroflow (Sorin Group Italia, Saluggia, Vercelli, Italy) bioprostheses. We aimed to evaluate our clinical experience with the Mitroflow LXA prosthesis for aortic valve replacement. METHODS: We prospectively analyzed data from 227 consecutive patients (133 males, mean age 73.9±9.2 years) implanted with the Mitroflow LXA between February 2007 and October 2011. Follow-up data were obtained by contacting the referring cardiologists. Kaplan-Meier curves were constructed for all-cause mortality, valve related mortality and structural valve degeneration (SVD). Multivariable analysis was conducted to identify SVD predictors. RESULTS: Median follow-up time was 54.2±37.9 months and completeness of follow-up was 95%. Overall mortality in the entire series was at 31% (N.=71) and mortality from cardiac or unknown causes at 20% (N.=46). SVD occurred in 24 patients (10%) (median delay between implantation and diagnosis: 62.6 (36.5) months). Reintervention was required in 20 cases (13 redo surgery, 7 percutaneous transcatheter valve intervention). The 8 years actuarial global survival was 54.7±4.9%, freedom from valve related mortality 67.5±4.9% and freedom from SVD 72±8%. The estimated freedom from SVD was significantly (P=0.007) longer in larger prosthesis (diameter >21 mm, 77±11%) compared to the smaller devices (≤21 mm, 59±13%.). Multivariate analysis identified smaller prostheses and age at implantation as independent predictors of SVD. CONCLUSIONS: The Mitroflow LXA showed evidence of early SVD in this cohort. A close follow-up of these patients is strongly advised.

Remodeling root repair with an external aortic ring annuloplasty.

OBJECTIVE: Although the remodeling technique provides the most dynamic valve-sparing root replacement, a dilated annulus (>25 mm) is a risk factor for failure. Aortic annuloplasty aims to reduce the annulus diameter, thus increasing coaptation height to protect the repair. The results of 177 patients with remodeling and external aortic ring annuloplasty were studied. METHODS: Data were collected from the Aortic Valve repair InternATiOnal Registry. Preoperative aortic insufficiency grade 3 or greater was present in 79 patients (44.7%). The valve was bicuspid in 59 patients (33.3%). External annuloplasty was performed through a homemade Dacron ring (56) or a dedicated expansible aortic ring (121). RESULTS: Thirty-day mortality was 2.9% (5). Mean follow-up was 41.1 ± 36.4 months. For the whole series, freedom from valve-related reoperation, aortic insufficiency grade 3 or greater, aortic insufficiency grade 2 or greater, and major adverse valve-related events were 89.5%, 90.5%, 77.4%, and 86.6% at 7 years, respectively, with similar results for tricuspid and bicuspid valves. Since 2007, systematic use of calibrated expansible ring annuloplasty, followed 1 year later by systematic cusp effective height assessment, significantly increased 7-year freedom from valve-related reoperation, aortic insufficiency grade 3 or greater, and major adverse valve-related events up to 99.1% ± 0.9% (P = .017), 100% (P = .026), and 96.3% ± 1.8% (P = .035), respectively, whereas freedom from aortic insufficiency grade 2 or greater remained unaffected (78.1% ± 7.6%). Calibrated annuloplasty and effective height assessment were identified as protective factors from reoperation: hazard ratio, 0.13; 95% confidence interval, 0.02-1.06; P = .057 and hazard ratio, 0.11; 95% confidence interval, 0.01-0.95; P = .044, respectively. CONCLUSIONS: The standardization of remodeling root repair with calibrated expansible aortic ring annuloplasty and cusp effective height assessment improves valve repair outcomes.