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1.
J Heart Valve Dis ; 23(6): 795-802, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25790630

RESUMO

BACKGROUND AND AIM OF THE STUDY: Aortic stenosis (AS) is the most frequent heart valve disease in western countries, and its prevalence increases with age. Sutureless valves have recently become available that allow the surgical procedures to be shortened. The study aim was to assess clinical outcome after sutureless aortic valve replacement (SAVR) performed with the Perceval S bioprosthesis at the authors' institution. METHODS: Between June 2007 and November 2011, a total of 143 patients (78 females, 65 males; mean age 79.4 +/- 5.9 years) was prospectively enrolled and followed at the authors' center. The median preoperative logistic EuroSCORE was 12.04 +/- 10.7. Preoperatively, 58.8% of patients were in NYHA class III or IV, and the mean gradient and effective orifice area (EOA) were 38.8 +/- 17 mmHg and 0.76 +/- 0.24 cm2, respectively. Isolated SAVR was performed in 95 patients (66.4%), while associated procedures were necessary in 48 patients (33.6%). The follow up was 100% complete (mean 13.4 +/- 11.6 months; range: 0-5 years; total cumulative follow up 155 patient-years). RESULTS: The procedural success rate was 99.3%. The mean cross-clamp and cardiopulmonary bypass times were 32.0 +/- 14.9 min and 44.7 +/- 18.6 min, respectively. In-hospital mortality was 4.9% (n=7). Pacemaker implantation was required in seven patients (4.9%). Survival at five years was 85.5%. Reoperation was necessary in seven patients (4.9%); early reoperations were due to paravalvular leak (n = 3; 2.0%) and intra-prosthetic regurgitation (n=3; 2.0%). One late reoperation (at 29 months) was required, due to fibrous pannus overgrowth. One late endocarditis (0.7%) occurred at 26 months and was medically treated. No structural valve deterioration occurred during the follow up. At 12 months, 94.4% of survivors were in NYHA class I-II, and the mean pressure gradient and EOA were 9.0 +/- 3.4 mmHg and 1.60 +/- 0.3 cm2, respectively. CONCLUSION: The Perceval S valve appears to be a safe option for SAVR, though further follow up is needed to evaluate the long-term outcome with this bioprosthesis.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Ecocardiografia , Feminino , Seguimentos , França/epidemiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar , Humanos , Masculino , Assistência Perioperatória/métodos , Complicações Pós-Operatórias/classificação , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/mortalidade , Desenho de Prótese , Reoperação/métodos , Reoperação/estatística & dados numéricos , Índice de Gravidade de Doença , Análise de Sobrevida , Resultado do Tratamento
2.
Artigo em Inglês | MEDLINE | ID: mdl-38914371

RESUMO

OBJECTIVES: In remodeling valve sparing root replacement with external annuloplasty, we compare long-term outcomes of calibrated expansible Extra-Aortic Ring to homemade Dacron ring. METHODS: All patients (2003-2020) operated for root aneurysm with/without AI were included. The standardized CAVIAAR technique was root remodeling and external annuloplasty ring, with Extra-Aortic Ring or homemade Dacron ring. RESULTS: Among 486 patients (age: 52.3±14.0 years) operated for root aneurysm, 375 (repair rate: 77.1%) underwent root remodeling with annuloplasty (Extra-Aortic Ring (n=289) vs Dacron ring (n=86)). At 10 years (median follow-up: 4.08 years, IQR [1.95,7.61]), unmatched and matched analysis showed that patients with Extra-Aortic Ring had higher survival, similar to the general population (93.3% vs 79.9%, p=0.097), lower reoperation incidence (2.0% vs 9.7%, p=0.0098) and lower AI grade>2 recurrence (1.9% vs 11.2%, p=0.0042), compared to patients with Dacron ring. Mixed-effect model showed that with Extra-Aortic Ring annuloplasty, annular dilation over time (p=0.0033) was prevented and, compared to homemade Dacron ring, root expansibility was better preserved (3.22% vs 2.12%, p=0.002) and mean transvalvular gradient was lower (6.58mmHg vs 7.94mmHg, p=0.001). Tricuspid and bicuspid valves with Extra-Aortic Ring had similar reoperation (4.3% vs 0.85%, p=0.65) and AI grade>2 incidence (2.7% vs 1.2%, p=0.61), expansibility (p=0.29) and diameter (p=0.47), while mean transvalvular gradient was lower for tricuspid valves (5.58mmHg vs 7.60mmHg, p=0.004). CONCLUSIONS: Valve sparing root remodeling with calibrated expansible Extra-Aortic Ring annuloplasty improves outcomes of reoperation and recurrent AI, compared to homemade Dacron ring. It prevents dilation and maintains physiological root dynamics for durable valve repair.

3.
Arch Cardiovasc Dis ; 116(10): 453-459, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37640626

RESUMO

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.

4.
Eur J Cardiothorac Surg ; 62(4)2022 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-35165701

RESUMO

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.


Assuntos
Insuficiência da Valva Aórtica , Anuloplastia da Valva Cardíaca , Idoso , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/métodos , Estudos de Coortes , Humanos , Reoperação , Resultado do Tratamento
5.
Artigo em Inglês | MEDLINE | ID: mdl-36535821

RESUMO

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.

6.
Eur J Cardiothorac Surg ; 62(1)2022 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-35438171

RESUMO

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.


Assuntos
Insuficiência da Valva Aórtica , Anuloplastia da Valva Cardíaca , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/métodos , Humanos , Reoperação , Respeito , Resultado do Tratamento
7.
Eur J Cardiothorac Surg ; 62(2)2022 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-35583290

RESUMO

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.


Assuntos
Aneurisma Aórtico , Insuficiência da Valva Aórtica , Anuloplastia da Valva Cardíaca , Implante de Prótese de Valva Cardíaca , Humanos , Pessoa de Meia-Idade , Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/efeitos adversos , Aneurisma Aórtico/cirurgia , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Reoperação/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Estudos Retrospectivos
8.
J Cardiovasc Surg (Torino) ; 62(1): 12-18, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33185078

RESUMO

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.


Assuntos
Aneurisma Aórtico/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca , Implante de Prótese de Valva Cardíaca , Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/mortalidade , Aneurisma Aórtico/fisiopatologia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Anuloplastia da Valva Cardíaca/efeitos adversos , Anuloplastia da Valva Cardíaca/instrumentação , Anuloplastia da Valva Cardíaca/mortalidade , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Hemodinâmica , Humanos , Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Risco , Resultado do Tratamento
9.
Eur J Cardiothorac Surg ; 57(2): 308-316, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31292613

RESUMO

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.


Assuntos
Aneurisma Aórtico , Insuficiência da Valva Aórtica , Anuloplastia da Valva Cardíaca , Próteses Valvulares Cardíacas , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/efeitos adversos , Humanos , Resultado do Tratamento
10.
Arch Cardiovasc Dis ; 113(3): 168-175, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32067947

RESUMO

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.


Assuntos
Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca , Terapia por Exercício , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca , Adulto , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Anuloplastia da Valva Cardíaca/efeitos adversos , Anuloplastia da Valva Cardíaca/instrumentação , Terapia por Exercício/efeitos adversos , Tolerância ao Exercício , Estudos de Viabilidade , Feminino , França , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Risco , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
11.
Ann Cardiothorac Surg ; 8(3): 401-410, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31240187

RESUMO

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.

12.
BMJ Open ; 9(6): e026929, 2019 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-31213447

RESUMO

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.


Assuntos
Anti-Infecciosos Locais/administração & dosagem , Antissepsia/métodos , Procedimentos Cirúrgicos Cardíacos , Cuidados Pré-Operatórios/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , 2-Propanol/administração & dosagem , Administração Tópica , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Clorexidina/administração & dosagem , Protocolos Clínicos , Etanol/administração & dosagem , Humanos , Povidona-Iodo/administração & dosagem , Resultado do Tratamento
14.
J Cardiovasc Surg (Torino) ; 59(5): 746-752, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29786406

RESUMO

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.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Falha de Prótese , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Intervalo Livre de Doença , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Paris , Modelos de Riscos Proporcionais , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
J Thorac Cardiovasc Surg ; 153(5): 1033-1042, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28187973

RESUMO

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.


Assuntos
Aorta/cirurgia , Aneurisma Aórtico/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Valva Aórtica/anormalidades , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Anuloplastia da Valva Cardíaca/instrumentação , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aorta/diagnóstico por imagem , Aorta/fisiopatologia , Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/mortalidade , Aneurisma Aórtico/fisiopatologia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Doença da Válvula Aórtica Bicúspide , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Anuloplastia da Valva Cardíaca/efeitos adversos , Anuloplastia da Valva Cardíaca/mortalidade , Ecocardiografia Doppler em Cores , Feminino , França , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Polietilenotereftalatos , Complicações Pós-Operatórias/etiologia , Intervalo Livre de Progressão , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Adulto Jovem
16.
Eur J Cardiothorac Surg ; 50(2): 350-60, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27440158

RESUMO

OBJECTIVES: An untreated dilated aortic annulus is a major risk factor for failure of aortic valve-sparing operations or repair of either bicuspid or tricuspid valve. Aortic annuloplasty efficiently reduces the annulus and increases the coaptation height, thus protecting the repair. This study analyses long-term results of 232 consecutive patients operated on with a standardized and physiological approach to aortic valve repair according to each phenotype of the dystrophic ascending aorta. Subvalvular aortic annuloplasty was systematically added using an external aortic ring to reduce annulus diameter when ≥25 mm. METHODS: Data were collected into the multicentric international AVIATOR registry (AorticValve repair InternATiOnal Registry): 149 patients with root aneurysm underwent remodelling with an external ring; 21 patients with tubular aortic aneurysm underwent supracoronary grafts with an external open ring and 62 patients with isolated aortic insufficiency (AI) underwent double sub- and/or supravalvular external open ring annuloplasty. Preoperative AI ≥ Grade III was present in 58.6% (133), and the valve was bicuspid in 37.9% (88). RESULTS: Cusp repair was performed in 75.4% (175) patients. The 30-day operative mortality rate was 1.4% (3). The mean follow-up was 40.1 ± 37.8 months (0-145.5). The actuarial survival rate at 7 years was 89.9%. The rate of freedom from reoperation at 7 years was similar among each phenotype, being 90.5% for root aneurysms, 100% for tubular aortic aneurysms and 97.5% for isolated AI with no difference between the bicuspid and tricuspid valve. The rates of freedom from AI ≥ Grade 2 and from AI ≥ Grade 3 at 7 years were, respectively, 76.0 and 93.1% for root aneurysms, 92.9 and 100% for tubular aortic aneurysms and 57.3 and 82.2% for isolated AI. Eye balling repair achieved suboptimal valve competency when compared with systematic cusp effective height assessment, which tended to improve the rate freedom from reoperation, respectively, from 85.8 ± 5.5% to 98.9 ± 1.1% and the rate of freedom from AI ≥ Grade 3 from 89.8 ± 4.9% to 100%. For isolated AI, an additional sinotubular junction ring (double sub- and supravalvular annuloplasty) tended to reduce recurrent AI when compared with single subvalvular annuloplasty. CONCLUSIONS: External aortic ring annuloplasty provides a reproducible technique for aortic valve repair with satisfactory long-term results for each ascending aorta phenotype with bicuspid or tricuspid valve. Longer follow-up is ongoing with the AVIATOR registry.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/mortalidade , Ecocardiografia Transesofagiana , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
17.
Ann Thorac Surg ; 99(4): 1220-6, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25728963

RESUMO

BACKGROUND: Although reduction of a dilated aortic annulus is becoming an essential parameter for durable valve repair, anatomical descriptions of the annulus and surgical landmarks of the subvalvular plane for an external aortic annuloplasty remain to be defined. METHODS: Twenty hearts with normal anatomy with tricuspid aortic valves were studied. Annulus diameter, cusp geometric height, and interleaflet triangles heights were measured. The aortic root was dissected externally down to the subvalvular plane as to perform an external aortic annuloplasty or reimplantation procedure proximal anastomosis. Tissue thickness and dissection heights relative to the annulus were measured at each cusp nadir and at the middle of each interleaflet triangle. RESULTS: The mean annulus diameter, cusp geometric height, and interleaflet triangle heights were, respectively, 24.9 ± 0.2 mm, 19.7 ± 0.3 mm, and 20.1 ± 0.5 mm. External dissection of the aortic root reached the subvalvular plane below the nadir of left coronary cusp (-2.7 ± 0.4 mm), noncoronary (NC) cusp (-3.1 ± 0.3 mm), and the base of left-NC interleaflet triangle (-2.1 ± 0.4 mm). External dissection remained above the nadir of the right coronary cusp (+1.4 ± 0.4 mm), base of left-right interleaflet triangle (+2.4 ± 0.6 mm), and right-NC interleaflet triangle (+3.4 ± 0.3 mm). Mean tissue thickness between the inner and external side of the subvalvular plane was 2.5 ± 0.1 mm. CONCLUSIONS: External dissection of the aortic annulus allows subvalvular placement of an external aortic ring below the left and NC cusps and below or within 3 mm of the right cusp nadir in 80% of cases. An external aortic annuloplasty would induce at least a 5-mm reduction of annulus diameter, corresponding to tissue thickness. Precise anatomical landmarks are important to standardize aortic valve annuloplasty.


Assuntos
Valva Aórtica/anatomia & histologia , Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/métodos , Pontos de Referência Anatômicos , Cadáver , Dissecação , Educação Médica Continuada , Feminino , Humanos , Masculino , Valores de Referência , Valva Tricúspide/anatomia & histologia , Valva Tricúspide/cirurgia
18.
Eur J Cardiothorac Surg ; 47(3): 482-90; discussion 490, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24755102

RESUMO

OBJECTIVES: Aortic annuloplasty and preservation of root dynamics have been described as factors for durability of aortic valve repair. The objective of this study is to document the first clinical analysis of root dynamics after a standardized valve-sparing procedure for root aneurysms associating a calibrated expansible external aortic ring annuloplasty with a physiological remodelling of the aortic root (CAVIAAR technique: Conservative Aortic Valve surgery for aortic Insufficiency and Aneurysm of the Aortic Root). METHODS: Of the 600 patients operated on with the CAVIAAR technique, 60 consecutive patients from a single team underwent double independent reading of the echocardiographic analysis performed in the operative period and yearly after discharge until a maximum of 5-year follow-up. Forty-four patients had preoperative aortic insufficiency (AI) ≥grade 2 (73.3%) and 29 patients (48%) had bicuspid valves. RESULTS: The expansible aortic ring (median size 27 (25-27) mm) significantly reduced the aortic annular base diameter (from 28 (25-29) mm to 23 (21-24) mm) (P < 0.001) without a significant median transvalvular gradient increase (P = 0.545). Cusp repair was performed in 55 patients (91.7%). Operative mortality was 1.7% (1). During the median 19-month (95% confidential interval [11-26]) follow-up, annular diameter and cusp effective height remained stable. There were no valve-related reoperations. One patient died at 6 months postoperatively from congestive heart failure. Freedom from AI ≥grade 2 was 100% at 1-year follow-up and 96.8% ± 3.2% at 3-year follow-up. Systolic root expansibility of the four echocardiographic diameters (aortic annular base, sinuses of Valsalva level, sino tubular junction and tubular aorta) was maintained, throughout the follow-up period with the aortic annular base expansibility coefficient having consistently higher values than the three other levels. CONCLUSIONS: The expansible aortic ring achieved a complete calibrated external annuloplasty and maintained dynamics of the aortic root at mid-term follow-up. Whether this could be a factor for durability of aortic valve repair is currently under evaluation through the CAVIAAR study 10-year follow-up.


Assuntos
Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/instrumentação , Anuloplastia da Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Tratamentos com Preservação do Órgão/instrumentação , Tratamentos com Preservação do Órgão/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Aórtico/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Anuloplastia da Valva Cardíaca/efeitos adversos , Ecocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tratamentos com Preservação do Órgão/efeitos adversos , Complicações Pós-Operatórias , Desenho de Prótese , Adulto Jovem
19.
J Thorac Cardiovasc Surg ; 149(2 Suppl): S37-45, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25240525

RESUMO

OBJECTIVE: The study objective was to compare the 30-day outcomes of a standardized aortic valve repair technique (REPAIR group) associating root remodeling with an expansible aortic ring annuloplasty versus mechanical composite valve and graft (CVG group) replacement in treating aortic root aneurysms. METHODS: A total of 261 consecutive patients with aortic root aneurysm were enrolled in this multicentric prospective cohort (131 in the CVG group, 130 in the REPAIR group) in 20 centers. The main end point is a composite criterion including mortality; reoperation; thromboembolic, hemorrhagic, or infectious events; and heart failure. Secondary end points were major adverse valve-related events. Crude and propensity score adjusted estimates are provided. RESULTS: The mean age was 56.1 years, and the valve was bicuspid in 115 patients (44.7%). The median (interquartile range) preoperative aortic insufficiency grade was 2.0 (1.0-3.0) in the REPAIR group and 3.0 (2.0-3.0) in the CVG group (P = .0002). Thirty-day mortality was 3.8% (n = 5) in both groups (P = 1.00). Despite a learning curve and longer crossclamp times for valve repair (147.7 vs 99.8 minutes, P < .0001), the 2 groups did not differ significantly for the main criterion (odds ratio, 1.31; 95% confidence interval, 0.72-2.40; P = .38) or 30-day mortality (odds ratio, 0.99; 95% confidence interval, 0.28-3053; P = .99), with a trend toward more frequent major adverse valve-related events in the CVG group (odds ratio, 2.52; 95% confidence interval, 0.86-7.40; P = .09). At discharge, 121 patients (96.8%) in the REPAIR group had grade 0 or 1 aortic insufficiency. CONCLUSIONS: A new standardized approach to valve repair, combining an expansible aortic annuloplasty ring with the remodeling technique, presented similar 30-day results to mechanical CVG with a trend toward reducing major adverse valve-related events. Analysis of late outcomes is in process for 3- and 10-year follow-ups.


Assuntos
Aneurisma Aórtico/cirurgia , Valva Aórtica/anormalidades , Implante de Prótese Vascular , Anuloplastia da Valva Cardíaca , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Aórtico/diagnóstico , Aneurisma Aórtico/mortalidade , Valva Aórtica/cirurgia , Doença da Válvula Aórtica Bicúspide , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Anuloplastia da Valva Cardíaca/efeitos adversos , Anuloplastia da Valva Cardíaca/mortalidade , Distribuição de Qui-Quadrado , Intervalo Livre de Doença , Feminino , França , Doenças das Valvas Cardíacas/diagnóstico , Doenças das Valvas Cardíacas/mortalidade , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Preferência do Paciente , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Pontuação de Propensão , Estudos Prospectivos , Desenho de Prótese , Reoperação , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
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