Search

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist. (DOC 123 kb)

AIMS: To compare early and late mortality of acute isolated tricuspid valve infective endocarditis (TVIE) treated with valve repair or replacement.METHODS: Patients who were surgically treated for TVIE from 1983 to 2018 were retrieved from the Italian Registry for Surgical Treatment of Valve and Prosthesis Infective Endocarditis. All the patients were followed up by means of phone interview or calling patient referral physicians or cardiologists. Kaplan-Meier method was used to assess late survival and survival free from TVIE recurrence with log-rank test for univariate comparison. The primary end points were early mortality (30 days after surgery) and long-term survival free from TVIE recurrence.RESULTS: A total of 4084 patients were included in the registry. Among them, 149 patients were included in the study. Overall, 77 (51.7%) underwent TV repair and 72 (48.3%) TV replacement. Early mortality was 9% (13 patients). Expected early mortality according to EndoSCORE was 12%. The TV repair showed lower mortality and major complication rate (7% and 16%), compared with TV replacement (11% and 25%), but statistical significance was not reached. Median follow-up was 19.1 years (14.3-23.8). Late deaths were 30 and IE recurrences were 5. No difference in cardiac survival free from IE was found between the two groups after 20 years (80 ± 6% Repair Group vs 59 ± 13% Replacement Group, P = 0.3).CONCLUSIONS: Overall results indicate that once surgically addressed, TVIE has a low recurrence rate and excellent survival, apparently regardless of the type of surgery used to treat it.

OBJECTIVES Patients with recurrent mitral regurgitation after surgical repair are currently treated with a re-repair procedure or valve replacement. The aim of this study was to compare outcomes of our series of patients who underwent re-repair versus replacement in this setting. METHODS From 2003 to 2017, a total of 79 patients with recurrent mitral regurgitation underwent re-repair, group A (39), or replacement, group B (40). Mean follow-up was 7.4 ± 3.27 years (max 14.4). Inverse Probability of Treatment Weighting was used to create comparable distributions of the covariates; the Kaplan–Meier method was used for survival and competing risk analysis for time to cardiac death, time to recurrence of MR ≥3+ and MR ≥2+. RESULTS A re-repair was possible in 49.4% of patients (39/79). At hospital discharge, residual MR ≥2+ was present in 5 patients in group A, and none in group B (P CONCLUSIONS Recurrent significant mitral regurgitation after re-repair is not rare already at 8 years, but the survival tends to be worse after replacement. This finding calls for a very selective approach in pursuing a re-repair only when the intraoperative findings and the immediate results are very reassuring as far as long-term durability is concerned.

Objectives: To report mid-term results after MitraClip repair, according to mitral regurgitation (MR) mechanism, in a real-world single-center experience. Background: Mid-term outcomes of percutaneous edge-to-edge mitral repair in the real world are still limited. Methods: We assessed the follow-up results of patients treated with MitraClip at a single high-volume mitral center from 2008 to 2016. All patients underwent Heart-Team discussion, prospective data collection and enrolment in a dedicated outpatient clinic. Functional (FMR, n = 242, 68.6%) and degenerative (DMR, n = 97, 27.5%) MR patients were separately analyzed. Results: 5-Year survival was 53.5 ± 4.5% in FMR vs 57.1 ± 7.5% in DMR (P = 0.18). Reduced survival was strongly associated with worse left ventricle remodeling (ESV HR 1.01, CI 1.01–1.02, P < 0.001) in FMR, and with worse symptoms (New York Heart Association IV HR 6.72, CI 1.78–25.45, P = 0.005) in DMR. 5-Year cumulative incidence function for MR ≥ 3 was 23.7 ± 3.4% in FMR vs 27.9 ± 5.9% in DMR (P = 0.39), being associated with residual MR = 2 both in FMR (HR 4.67, CI 2.49–8.74, P < 0.001) and DMR (HR 7.15, CI 2.72–18.75, P < 0.001). At 5-year, patients in NYHA class I-II increased from 17.9% to 45.3% in FMR (P < 0.001) and from 33.3% to 51.3% in DMR (P < 0.001). Conclusions: In this single-center real-world experience, 5-year after MitraClip, half of the patients were alive and 3/4 were free from MR, both in FMR and DMR. Symptoms benefit was sustained in both groups. Advanced ventricular remodeling, advanced symptoms, and suboptimal MR reduction were associated with worse results. Refined patient selection, improved efficacy and more data will be all required to improve long-term outcomes.

Background Lung dysfunction commonly occurs after cardiopulmonary bypass (CPB). Randomized evidence suggests that the presence of expiratory flow limitation (EFL) in major abdominal surgery is associated with postoperative pulmonary complications. Appropriate lung recruitment and a correctly set positive end-expiratory pressure (PEEP) level may prevent EFL. According to the available data in the literature, an adequate ventilation strategy during cardiac surgery is not provided. The aim of this study is to assess whether a mechanical ventilation strategy based on optimal lung recruitment with a best PEEP before and after CPB and with a continuous positive airway pressure (CPAP) during CPB would reduce the incidence of respiratory complications after cardiac surgery. Methods/design This will be a single-center, single-blind, parallel-group, randomized controlled trial. Using a 2-by-2 factorial design, high-risk adult patients undergoing elective cardiac surgery will be randomly assigned to receive either a best PEEP (calculated with a PEEP test) or zero PEEP before and after CPB and CPAP (equal to the best PEEP) or no ventilation (patient disconnected from the circuit) during CPB. The primary endpoint will be a composite endpoint of the incidence of EFL after the weaning from CPB and postoperative pulmonary complications. Discussion This study will help to establish a correct ventilatory strategy before, after, and during CPB. The main purpose is to establish if a ventilation based on a simple and feasible respiratory test may preserve lung function in cardiac surgery. Trial registration ClinicalTrials.gov, ID: NCT02633423. Registered on 6 December 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3046-0) contains supplementary material, which is available to authorized users.

OBJECTIVES After mitral repair for degenerative mitral regurgitation (MR), no or mild (≤1+/4+) residual MR should remain. Occasionally patients are left with more than mild residual MR (>1+/4+) for a number of reasons. The aim of this study was to assess the late implications of such a suboptimal repair in a matched cohort study. METHODS From 2006 to 2013, a total of 2158 patients underwent mitral repair for degenerative MR in our institution. Fifty patients (2.3%) with residual MR >1+ at hospital discharge (study group) were matched up to 1:2 with 91 patients operated on during the same period who were discharged with MR ≤1+ (control group). The median follow-up was 8 years (interquartile range 6.3–10.1, longest 12.7 years). A comparative analysis of the outcomes in the 2 groups was performed. RESULTS Overall survival at 8 years was 87 ± 8% in the study group and 92 ± 3% in the control group (P = 0.23). There were 3 late deaths (6.0%) in the study group and 6 deaths (6.6%) in the control group. Freedom from reoperation was similar (P = 1.0). At 8 years the prevalence of MR ≥3+ was significantly higher in the study group (15.6% vs 2.1%, P CONCLUSIONS Residual MR more than mild at hospital discharge is associated with lower durability of mitral repair and the need for more medical therapy in the long term. However, even an initial optimal result does not completely arrest the progression of the degenerative process.

Background The aim of the study was to evaluate whether the type of ring used had an impact on the long-term results of mitral repair for degenerative mitral regurgitation (MR), due to posterior leaflet prolapse, treated with quadrangular or triangular resection. Methods From January 2002 to December 2008, 1406 patients with severe MR due to posterior leaflet prolapse underwent mitral repair. Of these patients, we selected 452 consecutive patients treated with the same repair approach. Mitral annuloplasty to complete the repair was performed with a posterior flexible band (n = 260) or a complete semi-rigid ring (n = 192). The 2 groups were comparable at baseline, and their clinical and echocardiographic outcomes were compared at long-term follow-up. Results Overall survival at 14 years was similar (P = .29). The cumulative incidence function of cardiac death, with noncardiac death as competing risk, showed no difference (P = .71). At 14 years, probability of recurrence of MR greater than or equal to 3+ was 1.11% in the flexible band group and 3.25% in the semi-rigid ring group (P = .073). At 14 years, probability of recurrence of MR greater than or equal to 2 was 13.49% in the band group vs 10.78% in the semi-rigid ring group (P = .897). Conclusions In patients requiring mitral valve repair for posterior leaflet prolapse, treated with the same repair approach, the type of annuloplasty ring has no impact on the incidence of cardiac death and recurrence of MR at 14 years. Whether these findings remain stable at longer follow-up should be further investigated.

The study sought to assess the long-term outcomes of the stand-alone Cox-Maze IV procedure in symptomatic patients with refractory, persistent, or long-standing persistent atrial fibrillation (AF).Fifty-nine consecutive patients (mean age 52 ± 10.5 years, previous catheter ablation 80%, left ventricular ejection fraction 55% ± 3.4%, median left atrial volume index 41 [interquartile range, 34-47] mL/mNo hospital deaths occurred and 1 (1.7%) patient required postoperative pacemaker implantation. Follow-up was 97% complete (median 5.8 [interquartile range, 3.92-7.11] years). The overall survival at 7 years was 97% ± 2.3%. The 7-year cumulative incidence function of AF recurrence and of AF recurrence off class I or III antiarrhythmic drugs (AADs), with death as competing risk, was 14.2% ± 5.6% (95% confidence interval [CI], 5.5%-26.8%) and 26.5% ± 6.9% (95% CI, 14.2%-40.4%), respectively. Multivariate analysis identified the duration of AF as the only predictor of AF recurrence (hazard ratio, 1.01; 95% CI, 1.01-1.02; P.001). At 7 years, the proportion of patients in sinus rhythm was 84%, of whom 74% were off class I or III AADs. At the last follow-up, 75% of patients were in European Heart Rhythm Association functional class I, no stroke and thromboembolic events were documented, and 70% of patients were off anticoagulation therapy. Left ventricular ejection fraction improved from 53% ± 3.4% at baseline to 59% ± 3.4% at follow-up (P = .003).This study confirmed the safety and efficacy in the long term (7 years) of the stand-alone Cox-Maze IV surgical procedure for persistent or long-standing persistent AF. Indeed, more than 70% of the patients were in sinus rhythm off class I or III AADs and off oral anticoagulation.

Mycobacterium chimaera infections have mainly been associated with the heater-cooler unit (HCU) and, ultimately, linked to contaminated aerosols in the operation room. The contamination status of HCUs seems to be influenced by the maintenance, therefore, according to the manufacturer’s recommendations, peracetic acid (Puristeril) was introduced to increase HCU cleaning and disinfection protocol maintenance. Aerosol dispersion from Puristeril during maintenance can cause adverse effects to nearby workers. We aim to describe our technique to reduce the impact of Puristeril on operating room staff and to limit dispersion of its aerosol in the environment by performing the cleaning procedure through a closed circuit.

Objectives Scanty data are available on 'second cross-clamping' following mitral valve repair in contemporary practice. The aim of this study was to evaluate the incidence, causes and outcomes of this event in patients referred for mitral repair for severe degenerative mitral regurgitation (MR). Methods The study population included 2318 patients with severe degenerative MR referred for mitral repair. A second cross-clamping was performed in 94 (4%) patients. Causes of the second cross-clamping, revising repair procedures, immediate echocardiographic outcomes and postoperative course were assessed and compared with the 'single cross-clamping cases' (2224 patients used as control). Clinical and echocardiographic follow-up information was available for 91 of the 94 second cross-clamping patients (97% complete) (median time 6 years, interquartile range 3-11). Results The most frequent causes of the second cross-clamping were residual MR >1+/4+ and systolic anterior motion. A residual prolapse was identified in 41 (43.5%) patients, systolic anterior motion in 22 (23.5%), untreated clefts in 14 (15%) and other mechanisms in 17 (18%). Second cardiopulmonary bypass and aortic cross-clamping times were 36 (range 28-50) and 23 (range 17-34) min, respectively. Hospital mortality was 0% in the second cross-clamping and 0.3% in the control group (P = 0.2). Postoperative complications and length of hospital stay were similar. At discharge, residual MR ≥2+/4+ was 2.1% in the second cross-clamping and 2.7% in the control group (P = 0.99). In the second cross-clamping, at 12 years, the cumulative incidence function of reoperation, recurrent MR ≥3+ and MR ≥2+ with death as competing risk were 5.7 ± 2.5% (95% confidence interval 2-12), 10.3 ± 4.3% (95% confidence interval 3.8-20) and 17 ± 5.2% (95% confidence interval 8-29), respectively. Conclusions In a large volume centre for mitral repair, a second cross-clamping is still performed in 3-5% of the patients. Because suboptimal immediate results are associated with impaired late outcomes of mitral reconstruction, a low threshold for a second cross-clamping seems to be justified. If the second repair is carried out with a relatively shorter additional cross-clamping time, mortality and morbidity are not increased and immediate and long-term results are very satisfactory.

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 moderatelysevere 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.