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1.
Asian Cardiovasc Thorac Ann ; : 2184923241259510, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38831608

ABSTRACT

OBJECTIVE: Partial upper sternotomy is preferred for isolated aortic valve replacement because of its optimal surgical visibility and favorable cosmetic outcomes; however, it is not commonly used for aortic root surgery, and the conventional median sternotomy is still the preferred method for most surgeons. We aimed to compare the safety and effectiveness of a minimally invasive approach (partial sternotomy [PS]) and conventional approach (median sternotomy [FS]) for aortic root surgery. METHODS: Patients who underwent aortic root surgery at our hospital from 2016 to 2021 were retrospectively enrolled and divided into two groups. After propensity score matching, the conventional group included 156 patients and the minimally invasive group-57 patients. RESULTS: Bicuspid aortic valves were observed in 63 (40.4%) and 33 (57.9%) patients in the FS and PS groups, respectively. Valve-sparing surgery was performed on 69 (44.2%) and 30 (52.6%) patients in the FS and PS groups, respectively. The minimally invasive approach was beneficial in terms of blood loss during the first 24 h after surgery (p = 0.029) and postoperative blood transfusion (p = 0.023). The survival rates and freedom from reoperation or severe aortic regurgitation after the David procedure were comparable between the standard and minimally invasive groups (p = 0.25; p = 0.66) at mid-term follow-up. CONCLUSIONS: A minimally invasive approach for aortic root surgery can be safely performed as the standard approach. Partial upper sternotomy has the advantage of lower blood loss in the early postoperative period and does not negatively affect the results of valve-sparing root replacement.

2.
Eur J Heart Fail ; 26(4): 994-1003, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38374610

ABSTRACT

AIMS: Tricuspid regurgitation (TR) is commonly observed in patients with severe left-sided valvular heart disease (VHD). This study sought to assess TR frequency, management and outcome in this population. METHODS AND RESULTS: Among 6883 patients with severe native left-sided VHD or previous left-sided valvular intervention enrolled in the EURObservational Research Programme prospective VHD II survey, moderate or severe TR was very frequent in patients with severe mitral VHD (30% when mitral stenosis, 36% when mitral regurgitation [MR]), especially in patients with secondary MR (46%), and rare in patients with severe aortic VHD (4% when aortic stenosis, 3% when aortic regurgitation). An increase in TR grade was associated with a more severe clinical presentation and a poorer 6-month survival (p < 0.0001). Rates of concomitant tricuspid valve (TV) intervention at the time of left-sided heart valve surgery were high at the time of mitral valve surgery (50% when mitral stenosis, 41% when MR). Concordance between class I indications (patients with severe TR) for concomitant TV surgery at the time of left-sided valvular heart surgery according to guidelines and real-practice decision-making was very good (88% overall, 95% in patients operated on for MR). CONCLUSION: In this large international prospective survey among patients with severe left-sided VHD, moderate/severe TR was frequent in patients with mitral valve disease and was associated with a poorer outcome as TR grade increased. In patients with severe TR, compliance to guidelines for class I indications for concomitant TV surgery at the time of left-sided heart valve surgery was very good.


Subject(s)
Severity of Illness Index , Tricuspid Valve Insufficiency , Humans , Tricuspid Valve Insufficiency/epidemiology , Tricuspid Valve Insufficiency/diagnosis , Male , Female , Europe/epidemiology , Aged , Prospective Studies , Middle Aged , Mitral Valve Insufficiency/epidemiology , Mitral Valve Insufficiency/diagnosis , Mitral Valve Insufficiency/surgery , Heart Valve Diseases/epidemiology , Heart Valve Diseases/diagnosis , Tricuspid Valve
3.
Life (Basel) ; 14(1)2024 Jan 15.
Article in English | MEDLINE | ID: mdl-38255740

ABSTRACT

A 63-year-old symptomatic female with apical hypertrophic cardiomyopathy and diastolic disfunction was admitted to the hospital. What is the best way to manage this patient? This study is a literature review that was performed to answer this question. The following PubMed search strategy was used: 'Hypertrophic obstructive cardiomyopathy' [All Fields] OR 'apical myectomy' [All Fields], NOT 'animal [mh]' NOT 'human [mh]' NOT 'comment [All Fields]' OR 'editorial [All Fields]' OR 'meta-analysis [All Fields]' OR 'practice-guideline [All Fields]' OR 'review [All Fields]' OR 'pediatrics [mh]'. The natural history of the disease has a benign prognosis; however, a watchful strategy was associated with the risk of adverse cardiovacular events. Contrastingly, transapical myectomy was associated with low surgical risk and acceptable outcomes. In our case, the patient underwent transapical myectomy with an unconventional post-operative period. Control echocardiography showed marked left ventricular (LV) cavity enlargement: LV end-diastolic volume, 74 mL; LV ejection fraction, 65%; and LV stroke volume index increased to 27 mL/m2. The patient was discharged 7 days after myectomy. At 6 months post-operation, the patient was NYHA Class I, with a 6 min walk test score of 420 m. Therefore, transapical myectomy may be considered as a feasible procedure in patients with apical hypertrophic cardiomyopathy and progressive heart failure.

4.
Front Cardiovasc Med ; 10: 1306445, 2023.
Article in English | MEDLINE | ID: mdl-38155981

ABSTRACT

Background: Despite numerous advantages of the Ross procedure, it presents a risk of late autograft and right ventricular outflow tract conduit failure. This study aimed to analyze the outcomes of autograft dysfunction reoperations using autograft-sparing and root replacement techniques. Methods: Between 2015 and 2023, 49 patients underwent redo root surgery in our institution. Autograft valve-sparing procedures (VSP) were performed in 20 cases and the Bentall procedure (BP) in 29 patients. The short and long-term clinical outcomes along with echocardiographic results of VSP and BP were investigated. Results: Overall early mortality rate was 2.0% with no significant difference between the groups. Severe autograft valve insufficiency at the time of redo (OR 4.07, P = 0.03) and patient age (OR 1.07, P = 0.04) were associated with a valve replacement procedure instead of VSP. The median follow-up duration was 34 months. No late deaths occurred in either group. Freedom from VSP failure and aortic prosthesis dysfunction were 93.8% and 94.1% in the VSP and BP groups, respectively. No reoperations were necessary in either group. Conclusion: Redo aortic root surgery can be safely performed in patients with autograft failure. Both root replacement and autograft valve-sparing procedures demonstrated acceptable results at mid-term follow-up. Early redo surgery pre-empting severe aortic insufficiency increases the likelihood of preservation of the dilated autograft valve.

5.
Biomedicines ; 11(11)2023 Nov 20.
Article in English | MEDLINE | ID: mdl-38002101

ABSTRACT

Valved conduits are often required to replace pulmonary arteries (PA). A widely used Contegra device is made of bovine jugular vein (BJV), preserved with glutaraldehyde (GA) and iso-propanol. However, it has several drawbacks that may be attributed to its chemical treatment. We hypothesized that the use of an alternative preservation compound may significantly improve BJV conduit performance. This study aimed to compare the macroscopic and microscopic properties of the BJV treated with diepoxide (DE) and GA in a porcine model. Twelve DE-BJVs and four Contegra conduits were used for PA replacement in minipigs. To assess the isolated influence of GA, we included an additional control group-BJV treated with 0.625% GA (n = 4). The animals were withdrawn after 6 months of follow-up and the conduits were examined. Explanted DE-BJV had a soft elastic wall with no signs of thrombosis or calcification and good conduit integration, including myofibroblast germination, an ingrowth of soft connective tissue formations and remarkable neoangiogenesis. The inner surface of DE-BJVs was covered by a thin neointimal layer with a solid endothelium. Contegra grafts had a stiffer wall with thrombosis on the leaflets. Calcified foci, chondroid metaplasia, and hyalinosis were observed within the wall. The distal anastomotic sites had hyperplastic neointima, partially covered with the endothelium. The wall of GA-BJV was stiff and rigid with degenerative changes, a substantial amount of calcium deposits and dense fibrotic formations in adventitia. An irregular neointimal layer was presented in the anastomotic sites without endothelial cover in the GA BJV wall. These results demonstrate that DE treatment improves conduit integration and the endothelialization of the inner surface while preventing the mineralization of the BJV, which may reduce the risk of early conduit dysfunction.

6.
BMC Anesthesiol ; 23(1): 389, 2023 11 29.
Article in English | MEDLINE | ID: mdl-38030971

ABSTRACT

BACKGROUND: This study was conducted to test the hypothesis that phosphocreatine (PCr), administered intravenously and as cardioplegia adjuvant in patients undergoing cardiac surgery with prolonged aortic cross clamping and cardiopulmonary bypass (CPB) time, would decrease troponin I concentration after surgery. METHODS: In this randomized, double-blind, placebo-controlled pilot study we included 120 patients undergoing double/triple valve repair/replacement under cardiopulmonary bypass in the cardiac surgery department of a tertiary hospital. The treatment group received: intravenous administration of 2 g of PCr after anesthesia induction; 2.5 g of PCr in every 1 L of cardioplegic solution (concentration = 10 mmol/L); intravenous administration of 2 g of PCr immediately after heart recovery following aorta declamping; 4 g of PCr at intensive care unit admission. The control group received an equivolume dose of normosaline. RESULTS: The primary endpoint was peak concentration of troponin I after surgery. Secondary endpoints included peak concentration of serum creatinine, need for, and dosage of inotropic support, number of defibrillations after aortic declamping, incidence of arrhythmias, duration of Intensive Care Unit (ICU) stay, length of hospitalization. There was no difference in peak troponin I concentration after surgery (PCr, 10,508 pg/ml [IQR 6,838-19,034]; placebo, 11,328 pg/ml [IQR 7.660-22.894]; p = 0.24). There were also no differences in median peak serum creatinine (PCr, 100 µmol/L [IQR 85.0-117.0]; placebo, 99.5 µmol/L [IQR 90.0-117.0]; p = 0.87), the number of patients on vasopressor/inotropic agents (PCr, 49 [88%]; placebo, 57 [91%]; p = 0.60), the inotropic score on postoperative day 1 (PCr, 4.0 (0-7); placebo, 4.0 (0-10); p = 0.47), mean SOFA score on postoperative day 1 (PCr, 5.25 ± 2.33; placebo, 5,45 ± 2,65; p = 0.83), need for defibrillation after declamping of aorta (PCr, 22 [39%]; placebo, 25 [40%]; p = 0.9),, duration of ICU stay and length of hospitalization as well as 30-day mortality (PCr, 0 (0%); placebo,1 (4.3%); p = 0.4). CONCLUSION: PCr administration to patients undergoing double/triple valve surgery under cardiopulmonary bypass is safe but is not associated with a decrease in troponin I concentration. Phosphocreatine had no beneficial effect on clinical outcomes after surgery. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov with the Identifier: NCT02757443. First posted (published): 02/05/2016.


Subject(s)
Cardiac Surgical Procedures , Troponin I , Humans , Phosphocreatine , Creatinine , Treatment Outcome , Cardiopulmonary Bypass
7.
Article in English | MEDLINE | ID: mdl-37860854

ABSTRACT

A right anterior minithoracotomy is the least-frequently utilized approach in minimally invasive aortic valve surgery; moreover, this access is rarely used for aortic root procedures. With careful patient selection, some technical considerations, e.g. institution of peripheral cardiopulmonary bypass, and a sufficient learning curve, the right anterior minithoracotomy can become a convenient access for surgical interventions on the aortic root. We present the case of a 31-year-old female patient with Marfan syndrome and severe aortic regurgitation due to an aortic root aneurysm. We demonstrate a step-by-step guide through the David procedure via a right anterior minithoracotomy.


Subject(s)
Aortic Valve Insufficiency , Heart Valve Prosthesis Implantation , Female , Humans , Adult , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Treatment Outcome , Thoracotomy/methods , Aortic Valve Insufficiency/surgery , Minimally Invasive Surgical Procedures/methods
8.
J Am Heart Assoc ; 12(10): e028716, 2023 05 16.
Article in English | MEDLINE | ID: mdl-37183832

ABSTRACT

Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no-occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no-occlusion group, a mean difference of -$612 (95% CI, -$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of -$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Surgical Procedures , Stroke , United States/epidemiology , Humans , Aged , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Appendage/surgery , Medicare , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Stroke/prevention & control , Stroke/complications , Costs and Cost Analysis , Treatment Outcome
9.
Clin Case Rep ; 10(8): e04174, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36052022

ABSTRACT

Minimally invasive mitral valve repair and ablation of atrial fibrillation, combined with FVIII level-controlled replacement therapy, can be safely performed in patients with severe hemophilia.

10.
Article in English | MEDLINE | ID: mdl-35758623

ABSTRACT

OBJECTIVES: The appropriate approach for surgical repair of coarctation of the aorta with a ventricular septal defect (VSD) remains controversial. This study evaluated the outcomes of primary repair of VSDs with periventricular device closure without cardiopulmonary bypass through a left thoracotomy in patients without arch hypoplasia. METHODS: We selected 21 patients aged <1 year, including 7 neonates, who underwent repair of coarctation of the aorta with periventricular device closure of a VSD. RESULTS: The median occluder size was 6 (range, 5-8) mm. The median mechanical ventilation time was 14 (range, 2-68) h, and the median duration of hospital stay was 11 (range, 7-16) days. No reoperations were required to correct VSD shunting, and the median residual shunt size was 1 (range, 1-2) mm. The median follow-up period was 13 (range, 4-31) months. No late deaths were reported, and no haemodynamically significant pressure gradient at the anastomotic site was observed. The median distal aortic arch z-score was 0.39 (range, -0.1-to 0.9). Only 1 patient had a permanent pacemaker implanted towards the end of the follow-up period. CONCLUSIONS: Periventricular device closure can be used safely for closure of VSD in children with coarctation of the aorta without a hypoplastic aortic arch, even in neonates, to reduce the risk of prolonged cardiopulmonary bypass. This hybrid approach can be performed with a low incidence of rhythm disturbances and residual shunting. However, a meticulous assessment of the VSD anatomy is essential to avoid any unfavourable events.


Subject(s)
Aortic Coarctation , Cardiac Surgical Procedures , Heart Septal Defects, Ventricular , Aorta , Aorta, Thoracic/abnormalities , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Coarctation/complications , Aortic Coarctation/diagnostic imaging , Aortic Coarctation/surgery , Cardiopulmonary Bypass/adverse effects , Child , Heart Septal Defects, Ventricular/diagnostic imaging , Heart Septal Defects, Ventricular/surgery , Humans , Infant , Infant, Newborn , Treatment Outcome
11.
Article in English | MEDLINE | ID: mdl-35470990

ABSTRACT

A right anterior minithoracotomy is a surgical approach that can be an excellent alternative to a median sternotomy. However, for aortic root interventions, the median sternotomy is still the gold standard. Most surgeons are slow to master this method because the visualization is poor and less convenient. These problems can be solved by careful selection of patients and using some technical tricks. The patient is a male with a severe aortic valve lesion and an aneurysm of the ascending aorta involving the proximal arch. We demonstrate step-by- step how to perform a minimally invasive Bio-Bentall procedure with a "hemiarch" replacement through a right anterolateral thoracotomy.


Subject(s)
Heart Valve Prosthesis Implantation , Thoracotomy , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Humans , Male , Minimally Invasive Surgical Procedures/methods , Retrospective Studies , Sternotomy/methods , Thoracotomy/methods , Treatment Outcome
12.
Interact Cardiovasc Thorac Surg ; 34(4): 540-547, 2022 03 31.
Article in English | MEDLINE | ID: mdl-34791269

ABSTRACT

OBJECTIVES: Concomitant atrial fibrillation ablation during mitral valve (MV) surgery using radio frequency energy sources has been reported previously with excellent outcomes. However, data regarding the effectiveness of concomitant cryoablation remain limited. This study aimed to assess the efficacy of concomitant cryoablation in patients scheduled for MV surgery. METHODS: Between 2012 and 2020, 242 adult patients who underwent MV surgery and concomitant cryoablation were included. Data on rhythm, medication status and clinical events were assessed at 3, 6 and 12 months, then annually thereafter. RESULTS: Early mortality was 0.4%. The mean follow-up period duration was 43.9 months. The survival rates at 1, 3 and 5 years were 97.3%, 94.3% and 87.7%, respectively. The rates of freedom from atrial arrhythmia paroxysms at 1, 3 and 5 years were 79.0%, 64.0% and 60.5%, respectively. Atrial arrhythmia recurrence was associated with isolated left atrial lesion set (P = 0.038), large right atrial size (P = 0.002), lower surgeon experience (P = 0.003) and atrial fibrillation paroxysms in the early postoperative period (P = 0.002). CONCLUSIONS: Concomitant cryoablation during MV surgery is a safe and reproducible technique. The procedure provides acceptable freedom from atrial arrhythmias recurrences during long-term follow-up. The biatrial lesion set has advantages over the left atrium pattern in terms of atrial arrhythmias freedom. Surgeon experience significantly influences atrial fibrillation ablation success. Randomized trials are needed to compare radiofrequency and cryoablation.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Adult , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/methods , Cryosurgery/adverse effects , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Treatment Outcome
13.
Heart Lung Circ ; 30(12): 1949-1957, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34629244

ABSTRACT

BACKGROUND: Tricuspid valve repair for functional regurgitation is effectively performed with different annuloplasty devices. However, it remains unclear whether there are advantages associated with rigid rings compared to flexible bands. This prospective randomised study aimed to compare results of using a flexible band ring versus a rigid ring for functional tricuspid regurgitation in patients undergoing mitral valve surgery. METHODS: A single-centre randomised study was designed to allocate patients with functional tricuspid regurgitation undergoing mitral valve surgery to be treated with a flexible band or rigid ring. These patients were analysed by echocardiographic follow-up. The primary outcome was freedom from recurrent tricuspid regurgitation at 12-months follow-up. Secondary outcomes were 30-day mortality, survival, freedom from tricuspid valve reoperation, right ventricular reverse remodelling, and rate of major adverse events. RESULTS: A total of 308 patients were allocated to receive concomitant tricuspid valve annuloplasty with the flexible band or rigid ring. There was no between-group difference in freedom from recurrent tricuspid regurgitation: 97.3% in Rigid group (95% CI, 93.0-98.8) and 96.2% in the Flexible group (95% CI, 92.0-98.5) at 12-months follow-up (log-rank, p=0.261). Early mortality, survival, freedom from tricuspid valve reoperation, and global right ventricle systolic function were also comparable in both groups of patients. However, the flexible band had advantage in restoring regional right ventricle function (Doppler-derived systolic velocities of the annulus [S], tricuspid annular plane systolic excursion) at 12-months follow-up. CONCLUSION: Both the rigid ring and flexible band offered acceptable outcomes for functional tricuspid regurgitation correction without significant differences, as assessed at 12-months follow-up.


Subject(s)
Cardiac Valve Annuloplasty , Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency , Tricuspid Valve Insufficiency , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Neoplasm Recurrence, Local , Prospective Studies , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery
14.
World J Pediatr Congenit Heart Surg ; 12(5): 605-613, 2021 09.
Article in English | MEDLINE | ID: mdl-34597209

ABSTRACT

BACKGROUND: To assess the impact of diagnostic procedures in identifying residual lesions during extracorporeal membrane oxygenation (ECMO) on survival after pediatric cardiac surgery. METHODS: Between January 2012 and December 2017, 74 patients required postcardiotomy ECMO. Patients were retrospectively divided into 2 groups: Group I underwent only echocardiography ([echo only] 46 patients, 62.2%) and group II (echo+) underwent additional diagnostic tests (ie, computed tomography [CT] or cardiac catheterization; 28 patients, 37.8%). Propensity score matching was used to balance the 2 groups by baseline characteristics. RESULTS: Two equal groups (28 patients in each group) were formed by propensity score matching. Fourteen (50%) patients in the echo-only group and 20 (71%) patients in the echo+ group were successfully weaned from ECMO (P = .17). Four (14.3%) patients survived in the echo-only group and 15 (53.5%) patients survived in the echo+ group (P = .004). Patients in the echo+ group had a lower chance of dying compared to the echo-only group (odds ratio, 0.14.6; 95% CI, 0.039-0.52; P = .003). The residual lesions, which may have served as a mortality factor, were found by autopsy in 8 (40%) patients in the echo-only group, while none were found in the echo+ group (P = .014). CONCLUSIONS: The autopsies of patients who died despite postcardiotomy ECMO support showed that in 40% of cases that had been investigated by echo only, residual lesions that had not been detected by echocardiography were present. The cardiac catheterization and CT during ECMO are effective and safe for identifying residual lesions. Early detection and repair of residual lesions may increase the survival rate of pediatric cardiac patients on ECMO.


Subject(s)
Cardiac Surgical Procedures , Extracorporeal Membrane Oxygenation , Cardiac Catheterization/adverse effects , Cardiac Surgical Procedures/adverse effects , Child , Echocardiography , Extracorporeal Membrane Oxygenation/adverse effects , Humans , Retrospective Studies , Treatment Outcome
15.
BMJ Open ; 11(9): e046198, 2021 09 16.
Article in English | MEDLINE | ID: mdl-34531204

ABSTRACT

INTRODUCTION: In non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm. METHODS AND ANALYSIS: Ross for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18-60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented. ETHICS AND DISSEMINATION: REVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03798782 PROTOCOL VERSION: January 29, 2019 (Final Version 1.0).


Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Adult , Aortic Valve/surgery , Humans , Middle Aged , Pilot Projects , Treatment Outcome
17.
N Engl J Med ; 384(22): 2081-2091, 2021 06 03.
Article in English | MEDLINE | ID: mdl-33999547

ABSTRACT

BACKGROUND: Surgical occlusion of the left atrial appendage has been hypothesized to prevent ischemic stroke in patients with atrial fibrillation, but this has not been proved. The procedure can be performed during cardiac surgery undertaken for other reasons. METHODS: We conducted a multicenter, randomized trial involving participants with atrial fibrillation and a CHA2DS2-VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating greater risk of stroke) who were scheduled to undergo cardiac surgery for another indication. The participants were randomly assigned to undergo or not undergo occlusion of the left atrial appendage during surgery; all the participants were expected to receive usual care, including oral anticoagulation, during follow-up. The primary outcome was the occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism. The participants, research personnel, and primary care physicians (other than the surgeons) were unaware of the trial-group assignments. RESULTS: The primary analysis population included 2379 participants in the occlusion group and 2391 in the no-occlusion group, with a mean age of 71 years and a mean CHA2DS2-VASc score of 4.2. The participants were followed for a mean of 3.8 years. A total of 92.1% of the participants received the assigned procedure, and at 3 years, 76.8% of the participants continued to receive oral anticoagulation. Stroke or systemic embolism occurred in 114 participants (4.8%) in the occlusion group and in 168 (7.0%) in the no-occlusion group (hazard ratio, 0.67; 95% confidence interval, 0.53 to 0.85; P = 0.001). The incidence of perioperative bleeding, heart failure, or death did not differ significantly between the trial groups. CONCLUSIONS: Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it. (Funded by the Canadian Institutes of Health Research and others; LAAOS III ClinicalTrials.gov number, NCT01561651.).


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Embolism/prevention & control , Stroke/prevention & control , Administration, Oral , Aged , Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Cardiac Surgical Procedures , Combined Modality Therapy , Embolism/epidemiology , Female , Humans , Intraoperative Complications/epidemiology , Male , Middle Aged , Postoperative Complications/epidemiology , Risk , Severity of Illness Index , Stroke/epidemiology
18.
Heart Lung Circ ; 30(3): 438-445, 2021 Mar.
Article in English | MEDLINE | ID: mdl-32718898

ABSTRACT

BACKGROUND: To evaluate whether the Alfieri technique improves clinical and haemodynamic results and compare it with transaortic mitral valve secondary cord cutting in patients scheduled for septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. METHODS: Forty-eight (48) patients with moderate-to-severe systolic anterior motion (SAM)-mediated mitral regurgitation were randomly assigned to the Alfieri or Cutting groups in addition to septal myectomy. The primary endpoint was postoperative mean transmitral pressure gradient (TPG). The secondary endpoints were residual left ventricular outflow tract (LVOT) gradient after procedure, residual mitral regurgitation (MR), postoperative SAM, repeating bypass, and survival. RESULTS: There were no 30-day mortality and ventricular septal defects. The postoperative LVOT gradient was 15.4±7.6 mmHg and 11.1±4.9 mmHg (p=0.078) in the Alfieri and Cutting groups, respectively. The Alfieri technique was associated with higher peak (7.8±3.3 vs 4.7±2.8 mmHg; p=0.014) and mean (3.9±1.7 vs 2.1±1.6 mmHg; p=0.013) TPG. The Cutting group was associated with higher mild MR rate at discharge (six vs no patients; p=0.009). One (1) patient (4.2%) in the Alfieri group required pacemaker implantation owing to conduction disturbances (p=0.312). Two-year (2-year) freedom from late mortality and sudden cardiac death rates were 95.5%±4.4% and 100% for the Alfieri and Cutting groups, respectively (log rank, p=0.317). No patients had New York Heart Association functional class III or IV or moderate or severe MR. The maximum LVOT gradient was 20.4±15.2 mmHg and 16.7±10.4 mmHg, respectively (p=0.330). There were no reoperations during follow-up. CONCLUSIONS: Both techniques with septal myectomy effectively eliminated SAM-induced MR and LVOT obstructions in hypertrophic cardiomyopathy patients.


Subject(s)
Cardiac Surgical Procedures/methods , Cardiomyopathy, Hypertrophic/surgery , Heart Septum/surgery , Hemodynamics/physiology , Cardiomyopathy, Hypertrophic/physiopathology , Female , Humans , Male , Middle Aged , Pilot Projects , Treatment Outcome
19.
Eur J Cardiothorac Surg ; 59(1): 162-169, 2021 01 04.
Article in English | MEDLINE | ID: mdl-32864698

ABSTRACT

OBJECTIVES: Pulmonary allografts (AG) are the gold standard for right ventricular outflow tract (RVOT) reconstruction during the Ross procedure. However, there is limited availability of AG in some countries, and the use of alternative grafts for RVOT reconstruction remains controversial. This study aimed to compare the rates of freedom from RVOT graft dysfunction for AG and diepoxide-treated pericardial xenografts (DPXG). METHODS: Between 1998 and 2015, 793 adult patients underwent the Ross procedure in our centre. Using propensity score matching, the clinical outcomes and echocardiographic results of AG and DPXG were compared. RESULTS: Propensity score matching resulted in 2 groups (AG and DPXG) of 122 patients each. No difference was found in early mortality (2.5%) in both groups. The freedom from RVOT graft dysfunction curves were comparable between the AG and DPXG groups (P = 0.186) and the 8-year rates of freedom from graft dysfunction were 91.8% and 82.2%, respectively. The survival rates at 8 years were 90.5% and 90.1%, and the rates of freedom from RVOT reintervention at 8 years were 100% and 96.8% for the AG and DPXG groups, respectively. At discharge and follow-up, transprosthetic gradients were significantly higher in the DPXG group. The rate of the RVOT gradient progression was also higher in the DPXG group than in the AG group (1.80 ± 0.06 vs 1.39 ± 0.04 mmHg/year, P < 0.001). CONCLUSIONS: There was no difference in freedom from RVOT graft dysfunction by 8 years when using AG and DPXG in adult Ross patients, nor in survival and freedom from RVOT conduit reintervention. Long-term results need further evaluation.


Subject(s)
Heart Valve Prosthesis Implantation , Pulmonary Valve , Ventricular Outflow Obstruction , Adult , Allografts , Heart Ventricles/diagnostic imaging , Heart Ventricles/surgery , Heterografts , Humans , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/surgery , Treatment Outcome , Ventricular Outflow Obstruction/surgery
20.
Mater Sci Eng C Mater Biol Appl ; 118: 111473, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33255052

ABSTRACT

Bioprosthetic heart valves made from bovine pericardium (BP) and porcine pericardium (PP) preserved with glutaraldehyde (GA) are commonly used in valve surgeries but prone to calcification in many patients. In this study, we compared BP and PP preserved with GA, ethylene glycol diglycidyl ether (DE), and 1,2,3,4,6-penta-O-{1-[2-(glycidyloxy)ethoxy]ethyl}-d-glucopyranose (PE). We studied the stabilities of DE and PE in preservation media along with the amino acid (AA) compositions, Fourier-transform infrared spectra, mechanical properties, surface morphologies, thermal stability, calcification, and the cytocompatibility of BP and PP treated with 0.625% GA, 5% DE, 2% PE, and alternating 5% DE and 2% PE for 3 + 11 d and 10 + 10 d, respectively. Both epoxides were stable in the water-buffer solutions (pH 7.4). DE provided high linkage densities in BP and PP owing to reactions with Hyl, Lys, His, Arg, Ser, and Tyr. PE reacted weakly with these AAs but strongly with Met. High cross-linking density obtained using the 10 d + 10 d method provided satisfactory thermal stability of biomaterials. The epoxy preservations improved cytocompatibility and resistance to calcification. PE enhanced the stress/strain properties of the xenogeneic pericardia, perhaps by forming nanostructures that were clearly visualised in BP using scanning electron microscopy. The DE + PE combination, in an alternating cross-linking manner, thus constitutes a promising option for developing bioprosthetic pericardia.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis , Animals , Cattle , Cross-Linking Reagents , Glutaral , Humans , Pericardium , Swine
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