Systolic anterior motion after mitral valve repair: a predictive computational model.

OBJECTIVES: Systolic anterior motion (SAM) can be an insidious complication after mitral repair. Predicting SAM represents a challenge, even for very experienced mitral valve surgeons. The goal of this pilot work was to illustrate for the first time, a computational software able to calculate and prevent SAM during mitral repair. METHODS: Using MATLAB graphical user interface, a clinical software to predict SAM, we tested the performances of the software on 136 patients with degenerative mitral valves undergoing repair with standard techniques. A combination of 6 key echocardiographic parameters was used to calculate the SAM risk score. The discriminative performance of the model was assessed by the area under the receiver-operating characteristic curve. The receiver-operating characteristic was used to divide patients into low, medium and high risk for SAM. Simulation of virtual mitral repair (posterior leaflet resection and mitral ring annuloplasty) was also tested to reduce the risk of SAM. RESULTS: The incidence of SAM was 8.1%; 73% were detected as high risk by the software. The area under the receiver-operating characteristic model discriminant performance was 0.87 (95% confidence interval: 0.78-0.95). Simulating a posterior leaflet resection with the leaflet length fixed at 15 mm, the estimated SAM risk was updated, and all patients were then classified at low risk. CONCLUSIONS: This software is the first computational model designed to predict SAM during mitral repair to show excellent discrimination. This software has the potential to predict SAM risk preoperatively and, after a virtual step-by-step mitral repair simulation, depending on the technique adopted, to always achieve a low-risk SAM profile.

Interventions affecting mortality in critically ill and perioperative patients: A systematic review of contemporary trials.

PURPOSE: Confounders in randomized controlled trials (RCTs) reporting significant effects on mortality in critically ill patients using non-surgical techniques have not been systematically explored. We aimed to identify factors unrelated to the reported intervention that might have affected the findings and robustness of such trials. METHODS: We searched Pubmed/MEDLINE for all RCTs on any non-surgical interventions reporting an effect on unadjusted mortality in critically ill patients between 1/1/2000 and 1/12/2015. We assessed: the number needed to treat/harm (NNT or NNH), sample size, trial design (blinded/unblinded, single or multinational, single or multicenter (sRCT or mRCT)), intention to treat (ITT) analysis, and countries of origin. RESULTS: Almost half of RCTs were sRCTs. Median sample size was small, and 1/3 were not analyzed according to ITT principle. Lack of ITT analysis was associated with greater effect size (p=0.0028). Harm was more likely in mRCTs (p=0.002) and/or in blinded RCTs (p=0.003). Blinded RCTs had double sample size (p=0.007) and an increased NNT/NNH (p=0.002). Finally, mRCTs had higher NNT (p=0.005) and NNH (p=0.02), and harm was only detected in studies from Western countries (p=0.007). CONCLUSIONS: These observations imply that major systematic biases exist and affect trial findings irrespective of the intervention being studied.

Minimally invasive or conventional edge-to-edge repair for severe mitral regurgitation due to bileaflet prolapse in Barlow's disease: does the surgical approach have an impact on the long-term results?

OBJECTIVES: To evaluate whether the adoption of a right minithoracotomy operative approach had an impact on the long-term results of edge-to-edge (EE) repair compared to conventional sternotomy in patients with Barlow's disease and bileaflet prolapse. METHODS: We assessed the long-term results of 104 patients with Barlow's disease treated with a minimally invasive EE technique. An equal number of patients had a conventional median sternotomy EE repair for the same disease and were used as a control group. The inverse probability of treatment weighting was used to create comparable distributions of the covariates that were significantly different at baseline in the two groups. We performed a comparative analysis of the groups. RESULTS: No hospital deaths were observed. Follow-up was 99.5% complete (median 11.3 years). The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk, showed no difference between the two groups ( P = 0.87). At 12 years, the CIF of recurrent MR ≥ 3+, with death as the competing risk, was 7% in the sternotomy group and 5% in the minimally invasive group ( P = 0.30), and the CIF of recurrence of MR ≥ 2+ was 15 and 14%, respectively ( P = 0.63). The type of surgical approach was not a predictor of cardiac death, reoperation, recurrent MR ≥ 3+ or recurrent MR ≥ 2+. CONCLUSIONS: A minimally invasive approach does not have a negative impact on the effectiveness and long-term durability of the EE repair for bileaflet prolapse in Barlow's disease. Long-term outcomes are excellent, and valvular performance remains stable over time with no evidence of mitral stenosis.

Long-term results (up to 14 years) of the clover technique for the treatment of complex tricuspid valve regurgitation.

OBJECTIVES: To report the long-term results of the clover technique for the treatment of complex forms of tricuspid regurgitation (TR). METHODS: Ninety-six consecutive patients (mean age 60 ± 16.4, left ventricular ejection fraction 58 ± 8.8%) with severe or moderately-severe TR due to important leaflets prolapse/flail (81 patients), tethering (13 patients) or mixed (2 patients) lesions underwent clover repair combined with annuloplasty. The aetiology of TR was degenerative in 74 cases (77.1%), post-traumatic in 9 (9.4%) and secondary to dilated cardiomyopathy in 13 (13.5%). All patients but 3 (96.8%) underwent ring (59 patients, 61.5%) or suture (34 patients, 35.4%) annuloplasty. Concomitant procedures (mainly mitral surgery) were performed in 82 patients (85.4%). RESULTS: Hospital mortality was 7.2%. At hospital discharge 92 (95.8%) patients had no or mild TR. Follow-up was 98% complete (median 9 years, interquartile range 5.1; 10.9). At 12 years the overall survival was 71.6 ± 7.22% and the cumulative incidence function of cardiac death with non-cardiac death as competing risk 16 ± 4.1% [95% confidence interval (95% CI) 9.5-25.7]. At 12 years the cumulative incidence function of TR ≥ 3+ and TR ≥ 2+ with death as competing risk were 1.2 ± 1.2% (95% CI 0.1-5.8) and 28 ± 7.7% (95% CI 14.3-43.5), respectively. Preoperative left ventricular ejection fraction (hazard ratio 0.9, CI 0.9-1, P = 0.05) and previous cardiac surgery (hazard ratio 2.7, 95% CI 1-7.1, P = 0.03) were predictors of recurrent TR ≥ 2+ at univariable but not at multivariable analysis. CONCLUSIONS: Complex forms of TR due to severe prolapse or tethering of the leaflets can be effectively treated with the clover technique with very satisfactory long-term results and extremely low recurrence of severe TR.

Mid-term outcomes of concomitant surgical ablation of atrial fibrillation in patients undergoing cardiac surgery for hypertrophic cardiomyopathy†.

OBJECTIVES: Atrial fibrillation (AF) is common in patients with hypertrophic cardiomyopathy (HCM) and it is often poorly tolerated because of loss of atrial contraction and reduced filling time with rapid ventricular rates. Restoring sinus rhythm is of great clinical benefit to HCM patients. Very few data exist regarding surgical ablation of concomitant AF in this setting. The aim of this study was to evaluate the mid-term outcome of surgical AF ablation in patients who underwent cardiac surgery due to HCM. METHODS: Thirty-one consecutive patients with primary HCM and drug-refractory symptomatic AF underwent surgical ablation with concomitant septal myectomy (77%) and/or mitral valve repair/replacement (39%). Follow-up was 97% complete with a median of 6.4 years [3.8-9.1]. RESULTS: Hospital mortality was 6% and the overall survival at 7 years was 87 ± 6.1%. No stroke and thromboembolic events were documented at follow-up. The arrhythmia-free survival off antiarrhythmic drugs was 82 ± 7.3% at 1 year and 52 ± 10.2% at 6 years. The 1- and 6-year arrhythmia control (maintenance of sinus rhythm with or without antiarrhythmic drugs) was 96 ± 3.5 and 80 ± 8.1%, respectively. The recurrent arrhythmia was AF in all patients. No predictors of AF recurrence were detected. CONCLUSIONS: Concomitant surgical ablation of AF is a reasonable treatment option for drug refractory AF in patients with HCM undergoing surgical myectomy and/or mitral valve surgery. However, chronic antiarrhythmic drugs are needed to achieve a satisfactory mid-term arrhythmia control.

Can Perceval sutureless valve reduce the rate of patient-prosthesis mismatch?†.

OBJECTIVES: The aim of this study is to compare the theoretical incidence of patient-prosthesis mismatch (PPM) in patients undergoing a sutureless or a sutured aortic valve replacement using an exact statistical matching. METHODS: Between May 2012 and March 2016, 65 patients with severe symptomatic aortic stenosis underwent a sutureless aortic valve replacement with the Perceval bioprosthesis in 2 centres. Moreover, 177 aortic valve replacements with conventional sutured bioprosthesis were performed between August 2003 and September 2015. Perceval and sutured patients were 1:1 exactly matched for sex and body surface area (BSA), resulting in 62 couples (sutureless: BSA 1.77 ± 0.16 m 2 , female 62.9% vs sutured: BSA 1.77 ± 0.15 m 2 , female 62.9%). RESULTS: After matching, the indexed effective orifice area was 1.50 ± 0.18 cm 2 /m 2 and 0.81 ± 0.19 cm 2 /m 2 in the sutureless and the sutured group, respectively ( P < 0.001). No PPM occurred in patients who received a Perceval bioprosthesis ( n = 62). In the sutured group ( n = 62), 38 patients (61.3%) developed a PPM, which was moderate in 41.9% ( n = 26) and severe in 19.4% ( n = 12) ( P < 0.001). CONCLUSIONS: The indexed effective orifice area of the sutureless group was significantly larger than in the sutured one. The incidence of PPM with the conventional sutured biprosthesis was 61.3%, while it decreases to 0% in the sutureless group. No PPM was reported in the sutureless valve group. Therefore, the Perceval sutureless valve provides larger effective orifice areas compared to the sutured conventional bioprosthesis and could be considered as a good option to reduce the risk of a PPM.