10 Years of SYNTAX: Closing an Era of Clinical Research After Identifying New Outcome Determinants.

The SYNTAX trial randomized patients equally eligible for coronary artery bypass grafting or percutaneous coronary intervention using the Heart Team approach. The SYNTAXES study achieved a follow-up rate of 93.8% and reported the 10-year vital status. Factors associated with increased mortality at 10 years were pharmacologically treated diabetes mellitus, increased waist circumference, reduced left ventricular function, prior cerebrovascular and peripheral vascular disease, western Europe and North American descent, current smoking, chronic obstructive pulmonary disease, elevated C-reactive protein, anemia, and an increase in HbA1c. Procedural factors associated with higher 10 years mortality include periprocedural myocardial infarction, extensive stenting, small stents, ≥1 heavily calcified lesion, ≥1 bifurcation lesion, residual SYNTAX score >8, and staged percutaneous coronary intervention. Optimal medical therapy at 5 years, use of statins, on-pump coronary artery bypass grafting, multiple arterial grafts, and higher physical component score and mental component score were associated with lower mortality at 10 years. Numerous scores and prediction models were developed to help individualize risk assessment. Machine learning has emerged as a novel approach for developing risk models.

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification.

OBJECTIVES: The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). BACKGROUND: Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization. METHODS: This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG). RESULTS: The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (Pinteraction = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264). CONCLUSIONS: At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).

Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization.

AIMS: To evaluate the impact of various smoking status on 10-year all-cause mortality and to examine a relative treatment benefit of coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) according to smoking habits. METHODS AND RESULTS: The SYNTAX Extended Survival study evaluated vital status up to 10 years in 1800 patients with de novo three-vessel disease and/or left main coronary artery disease randomized to CABG or PCI in the SYNTAX trial. In the present analysis, patients were divided into three groups (current, former, or never smokers), and the primary endpoint of 10-year all-cause mortality was assessed according to smoking status. Smoking status was available in 1793 (99.6%) patients at the time of randomization, of whom 363 were current smokers, 798 were former smokers, and 632 were never smokers. The crude rates of 10-year all-cause mortality were 29.7% in current smokers, 25.3% in former smokers, and 25.9% in never smokers (Log-rank P = 0.343). After adjustment for imbalances in baseline characteristics, current smokers had a significantly higher risk of 10-year all-cause mortality than never smokers [adjusted hazard ratio (aHR): 2.29; 95% confidence interval (CI): 1.60-3.27; P < 0.001], whereas former smokers did not. PCI was associated with a higher risk of all-cause mortality than CABG among current smokers (HR: 1.60; 95% CI: 1.09-2.35; P = 0.017), but it failed to show a significant interaction between revascularization strategies and smoking status (Pinteraction = 0.910). CONCLUSION: Current smokers had a higher adjusted risk of 10-year all-cause mortality, whereas former smokers did not. The treatment effect of CABG vs. PCI did not differ significantly according to smoking status. CLINICAL TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972; SYNTAX Extended Survival. ClinicalTrials.gov reference: NCT03417050.

Long-term survival after coronary bypass surgery with multiple versus single arterial grafts.

OBJECTIVES: This study sought to evaluate the long-term differences in survival between multiple arterial grafts (MAG) and single arterial grafts (SAG) in patients who underwent coronary artery bypass grafting (CABG) in the SYNTAX study. METHODS: The present analysis included the randomized and registry-treated CABG patients (n = 1509) from the SYNTAX Extended Survival study (SYNTAXES). Patients with only venous (n = 42) or synthetic grafts (n = 1) were excluded. The primary end point was all-cause death at the longest follow-up. Multivariable Cox regression was used to adjust for differences in baseline characteristics. Sensitivity analysis using propensity matching with inverse probability for treatment weights was performed. RESULTS: Of the 1466 included patients, 465 (31.7%) received MAG and 1001 (68.3%) SAG. Patients receiving MAG were younger and at lower risk. At the longest follow-up of 12.6 years, all-cause death occurred in 23.6% of MAG and 40.0% of SAG patients [adjusted hazard ratio (HR) 0.74, 95% confidence interval (CI) (0.55-0.98); P = 0.038], which was confirmed by sensitivity analysis. MAG in patients with the three-vessel disease was associated with significant lower unadjusted and adjusted all-cause death at 12.6 years [adjusted HR 0.65, 95% CI (0.44-0.97); P = 0.033]. In contrast, no significance was observed after risk adjustment in patients with the left main disease, with and without diabetes, or among SYNTAX score tertiles. CONCLUSIONS: In the present post hoc analysis of all-comers patients from the SYNTAX trial, MAG resulted in markedly lower all-cause death at 12.6-year follow-up compared to a SAG strategy. Hence, this striking long-term survival benefit of MAG over SAG encourages more extensive use of multiple arterial grafting in selected patients with reasonable life expectancy. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050; SYNTAX ClinicalTrials.gov reference: NCT00114972.

Single or multiple arterial bypass graft surgery vs. percutaneous coronary intervention in patients with three-vessel or left main coronary artery disease.

AIM: The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). METHODS AND RESULTS: The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P < 0.001). Multiple arterial grafting [adjusted hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.49-0.89], but not SAG (adjusted HR 0.83, 95% CI 0.67-1.03), was associated with significantly lower all-cause mortality compared with PCI. In patients with 3VD, both MAG (adjusted HR 0.55, 95% CI 0.37-0.81) and SAG (adjusted HR 0.68, 95% CI 0.50-0.91) were associated with significantly lower mortality than PCI, whereas in LMCAD patients, no significant differences between PCI and MAG (adjusted HR 0.90, 95% CI 0.56-1.46) or SAG (adjusted HR 1.11, 95% CI 0.81-1.53) were observed. In patients with revascularization of all three major myocardial territories, a positive correlation was observed between the number of myocardial territories receiving arterial grafts and survival (Ptrend = 0.003). CONCLUSION: Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. TRIAL REGISTRATION: Registered on clinicaltrial.gov. SYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050); SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization.

BACKGROUND: The benefit of optimal medical therapy (OMT) on 5-year outcomes in patients with 3-vessel disease and/or left main disease after percutaneous coronary intervention or coronary artery bypass grafting (CABG) was demonstrated in the randomized SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial. OBJECTIVES: The objective of this analysis is to assess the impact of the status of OMT at 5 years on 10-year mortality after percutaneous coronary intervention or CABG. METHODS: This is a subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which evaluated for up to 10 years the vital status of patients who were originally enrolled in the SYNTAX trial. OMT was defined as the combination of 4 types of medications: at least 1 antiplatelet drug, statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. After stratifying participants by the number of individual OMT agents at 5 years and randomized treatment, a landmark analysis was conducted to assess the association between treatment response and 10-year mortality. RESULTS: In 1,472 patients, patients on OMT at 5 years had a significantly lower mortality at 10 years compared with those on ≤2 types of medications (13.1% vs 19.9%; adjusted HR: 0.470; 95% CI: 0.292-0.757; P = 0.002) but had a mortality similar to those on 3 types of medications. Furthermore, patients undergoing CABG with the individual OMT agents, antiplatelet drug and statin, at 5 years had lower 10-year mortality than those without. CONCLUSIONS: In patients with 3-vessel and/or left main disease undergoing percutaneous coronary intervention or CABG, medication status at 5 years had a significant impact on 10-year mortality. Patients on OMT with guideline-recommended pharmacologic therapy at 5 years had a survival benefit. (Synergy Between PCI With Taxus and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study.

BACKGROUND: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). METHODS: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR. RESULTS: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15-1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0-4 versus 28.9% for rSS>4-8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13-5.43]). CONCLUSIONS: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS<8) revascularization can be achieved with PCI in patients with 3-vessel disease, CABG should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03417050.

Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions.

BACKGROUND: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified. OBJECTIVES: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG. METHODS: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization. RESULTS: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837). CONCLUSIONS: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study.

BACKGROUND: Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear. METHODS AND RESULTS: The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04-1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54-2.40; p < 0.001). The risk of 10 year all-cause death was similar between patients receiving PCI or CABG irrespective of the presence of prior CEVD (p-interaction = 0.624). CONCLUSION: Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

Deep sternal wound infection - latissimus dorsi flap is a reliable option for reconstruction of the thoracic wall.

BACKGROUND: At present, data describing patients' long-term outcomes, quality of life, and survival after deep sternal wound infection are rarely available. The purpose of our study was to evaluate functional outcome and patient well-being after debridement and reconstruction of the sternal defect using a pedicled latissimus dorsi flap following deep sternal wound infection (DSWI). METHODS: This retrospective analysis reviewed 106 cases of DSWI after open-heart surgery treated between May 1, 2012, and May 31, 2015. The parameters of interest were demographic and medical data, including comorbidity and mortality. Follow-up consisted of physical examination of the patients using a specific shoulder assessment, including strength tests and measurements of pulmonary function. RESULTS: The population consisted of 69 (65%) male and 37 (35%) female patients. Their average age at the time of plastic surgery was 69 years (range: 35-85). The 30-day mortality was 20% (n = 21); after one-year, mortality was 47% (n = 50), and at follow-up, it was 54% (n = 58). Heart surgery was elective in 45 cases (42%), urgent in 31 cases (29%) and for emergency reasons in 30 cases (28%). The preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE) averaged 16.3 (range: 0.88-76.76). On the dynamometer assessment, a value of 181 Newton (N) (±97) could be achieved on the donor side, in contrast to 205 N (±91) on the contralateral side. The inspiratory vital capacity of the lung was reduced to an average of 70.58% (range: 26-118), and the forced expiratory volume in 1 s was decreased to an average of 69.85% (range: 38.2-118). CONCLUSIONS: Given that only small adverse effects in shoulder function, strength, and pulmonary function were observed, the latissimus dorsi flap appears to be a safe and reliable option for the reconstruction of the sternal region after DSWI.

Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial.

BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 248 (28%) patients had died after PCI and 212 (24%) after CABG (hazard ratio 1·19 [95% CI 0·99-1·43], p=0·066). Among patients with three-vessel disease, 153 (28%) of 546 had died after PCI versus 114 (21%) of 549 after CABG (hazard ratio 1·42 [95% CI 1·11-1·81]), and among patients with left main coronary artery disease, 95 (27%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·92 [0·69-1·22], pinteraction=0·023). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0·60) and no linear trend across SYNTAX score tertiles (ptrend=0·20). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

Dynamic mitral valve geometry in patients with primary and secondary mitral regurgitation: implications for mitral valve repair†.

OBJECTIVES: The goal of this study was to quantify the mitral valve (MV) annulus, the MV shape and the anatomical MV orifice area throughout the cardiac cycle using 4-dimensional MV analysis software in patients with primary mitral regurgitation (PMR) and secondary mitral regurgitation (SMR) in comparison to a healthy control group. METHODS: Three-dimensional transoesophageal echocardiograms of the MV were acquired for 29 patients with PMR, for 28 patients with SMR and for 18 healthy control subjects. The MV was quantified with regards to anterior-posterior and lateromedial diameter, annular area and circumference, intertrigonal (IT) distance, annular sphericity index, annular height to commissural width ration, and anatomical MV orifice area throughout the cardiac cycle using 3-dimensional transoesophageal echocardiography-based 4-dimensional MV advanced analysis software. RESULTS: Normal annulus dynamics display a systolic enlargement followed by an early-diastolic plateau phase and a late-diastolic contraction. The IT distance showed a linear association with the anterior-posterior diameter (= 1.11 × IT distance) and lateromedial diameter (= 1.44 × IT distance) in the control subjects. Mitral regurgitation is associated with a less dynamic, planar and dilated annulus with small variations between PMR and SMR. The IT distance was less affected by mitral regurgitation compared to the control subjects. CONCLUSIONS: The novel 4-dimensional MV analysis allows new insights into the dynamic MV geometry in patients with PMR and SMR compared to the control subjects. The IT distance may be used to predict annuloplasty ring sizing.

Aortic root enlargement to mitigate patient-prosthesis mismatch: do early adverse events justify reluctance?†.

OBJECTIVES:: Concomitant aortic root enlargement (ARE) at the time of surgical aortic valve replacement can be performed to avoid patient-prosthesis mismatch, an important predictor of adverse long-term outcome. METHODS:: We performed a single-centre, retrospective analysis of 4120 patients receiving isolated aortic valve replacement, of whom 171 (4%) had concomitant ARE between January 2005 and December 2015. The analysis of postoperative outcome and early mortality was performed. Owing to inequality of the groups, patients were matched 1:1. RESULTS:: The mean age of all 4120 patients was 68.8 ± 10.5 years, and comorbidities were equally balanced after matching. The mean aortic cross-clamp time, cardiopulmonary bypass time and total operative time were prolonged by 19, 20 and 27 min in the ARE group, respectively. Early mortality was not statistically significantly different with 1.4% in the surgical aortic valve replacement and 1.8% in the ARE group. Postoperative complications were <5% in all matched 338 patients: bleeding (3% vs 3%), pericardial effusion (3.0% vs 4.2%), sternal instability (1.8% vs 0%) and sternal wound infection (3.0% vs 1.2%). A significant higher number of patients had respiratory failure after ARE (unmatched: 17.1% vs 9.9%, P < 0.001; matched: 18.3% vs 9.5%, P = 0.028). Factors independently associated with overall mortality were age [hazard ratio (HR) 1.71], chronic obstructive pulmonary disease (HR 1.47), diabetes (HR 1.82), atrial fibrillation (HR 2.14) and postoperative respiratory failure (HR 2.84). CONCLUSIONS:: ARE can be performed safely in experienced centres with no significant increase in the risk of early postoperative surgical complications and early mortality. However, the surgeon and the intensive care unit team should be aware of an increased risk for postoperative respiratory failure in ARE patients.

Acute Effect of Mitral Valve Repair on Mitral Valve Geometry.

BACKGROUND: The aim of this study was to quantify acute mitral valve (MV) geometry dynamic changes throughout the cardiac cycle using three-dimensional transesophageal echocardiography (3D TEE) in patients undergoing surgical MV repair (MVR) with ring annuloplasty and optional neochord implantation. METHODS: Twenty-nine patients (63 ± 10 years) with severe primary mitral regurgitation underwent surgical MVR using ring annuloplasty with or without neochord implantation. We recorded 3D TEE data throughout the cardiac cycle before and after MVR. Dynamic changes (4D) in the MV annulus geometry and anatomical MV orifice area (AMVOA) were measured using a novel semiautomated software (Auto Valve, Siemens Healthcare). RESULTS: MVR significantly reduces the anteroposterior diameter by up to 38% at end-systole (36.8-22.7 mm; p < 0.001) and the lateromedial diameter by up to 31% (42.7-30.3 mm; p < 0.001). Moreover, the annular circumference was reduced by up to 31% at end-systole (129.6-87.6 mm, p < 0.001), and the annular area was significantly decreased by up to 52% (12.8-5.7 cm2; p < 0.001). Finally, the AMVOA experienced the largest change, decreasing from 1.1 to 0.2 cm2 during systole (at midsystole; p < 0.001) and from 4.1 to 3.2 cm2 (p < 0.001) during diastole. CONCLUSIONS: MVR reduces the annular dimension and the AMVOA, contributing to mitral competency, but the use of annuloplasty rings reduces annular contractility after the procedure. Surgeons can use 4D imaging technology to assess MV function dynamically, detecting the acute morphological changes of the mitral annulus and leaflets before and after the procedure.

Changes in dynamic mitral valve geometry during percutaneous edge-edge mitral valve repair with the MitraClip system.

BACKGROUND: The aim of this study was to quantify the acute dynamic changes of mitral valve (MV) geometry throughout the cardiac cycle-during percutaneous MV repair with the MitraClip system by 3-dimensional transesophageal echocardiography (3D TEE). METHODS: The MV was imaged throughout the cardiac cycle (CC) before and after the MitraClip procedure using 3D TEE in 28 patients (mean age, 77 ± 8 years) with functional mitral regurgitation (FMR). Dynamic changes in the MV annulus geometry and anatomical MV orifice area (AMVOA) were quantified using a novel semi-automated software. RESULTS: Percutaneous MV repair decreased anterior-posterior diameter by up to 9% (at 50% of CC; from 34.5 to 31.9 mm; p < 0.001) throughout the CC and increased the diastolic lateral-medial diameter by up to 7% (at 60% of the CC; from 39.7 to 42.3 mm; p < 0.001), whereas the annular circumference and area were not significantly affected. Annulus sphericity index was reduced up to 13% (at 50% of the CC; from 0.89 to 0.78, p < 0.001). The AMVOA also decreased during systole, the maximum decrease being from 0.6 to 0.2 mm2 (at 0% of CC; p = 0.007), and during diastole the maximum decrease being from 4.6 to 1.6 cm2 (at 50% of CC; p < 0.001). CONCLUSIONS: Percutaneous MV repair reduces the MR by an improved coaptation of MV leaflets joint with a simultaneous indirect reduction of anterior-posterior diameter. Further, the MitraClip procedure leads to a reduction of AMVOA of more than 60% during diastole.

Good 5-Year Durability of Transapical Beating Heart Off-Pump Mitral Valve Repair With Neochordae.

BACKGROUND: Transapical, beating heart, off-pump implantation of neochordae for repair of mitral valve (MV) prolapse is of increasing interest. The aim of this study was to evaluate long term results for MV repair using the NeoChord system (NeoChord, St. Louis Park, MN). METHODS: Six patients underwent treatment for severe primary mitral regurgitation (MR) with the NeoChord DS1000 system as part of the initial device safety and feasibility Transapical Artificial Chordae Tendinae (TACT) trial at our institution (University of Leipzig-Heart Center, Leipzig, Germany). The primary pathology in all patients was isolated posterior leaflet prolapse of the P2 or P3 segment, or both. RESULTS: Successful repair resulting in no or trace MR was achieved in 5 of 6 patients by implantation of three neochordae under transesophageal echocardiographic guidance and normal left ventricular loading conditions. One patient underwent intraoperative conversion to an open MV replacement as a result of leaflet injury. The early postoperative course was uneventful in all remaining patients. Two patients had to undergo reoperation for recurrent MR at 3 and 16 months postoperatively. The remaining 3 patients were followed up for a period of 5 years. These patients were free of cardiac symptoms, and transthoracic examination showed trace or mild to moderate MR at 1-, 2-, and 5-year follow-up. A trend toward reverse remodeling of the left ventricle with no increase in mitral annular dilatation over 5 years was observed. CONCLUSIONS: In select patients, MV repair using the NeoChord system results in very good long-term results without recurrent prolapse, MR, or annular dilatation.

Reversibility of severe mitral valve regurgitation after left ventricular assist device implantation: single-centre observations from a real-life population of patients.

OBJECTIVES: This study evaluates the impact of untreated preoperative severe mitral valve regurgitation (MR) on outcomes after left ventricular assist device (LVAD) implantation. METHODS: Of the 234 patients who received LVAD therapy in our centre during a 6-year period, we selected those who had echocardiographic images of good quality and excluded those who underwent mitral valve replacement prior to or mitral valve repair during LVAD placement. The 128 patients selected were divided into 2 groups: Group A with severe MR (n = 65) and Group B with none to moderate MR (n = 63, 28 with moderate MR). We evaluated transthoracic echocardiography preoperatively [15 (7-28) days before LVAD implantation; median (interquartile range)] and postoperatively up to the last available follow-up [501 (283-848) days after LVAD]. We collected mortality, complications and clinical status indicators of the patient cohort. RESULTS: We observed a significant decrease in the severity of MR after LVAD implantation (severe MR 51% pre- vs 6% post-LVAD implantation, P < 0.001). There was no difference between groups in terms of right heart failure, rate of urgent heart transplantation, pump thrombosis or ventricular arrhythmias. There was no difference in 1-year survival and 3-year survival (87.7% vs 88.4% and 71.8% vs 66.6% for Groups A and B, respectively, P = 0.97). CONCLUSIONS: Preoperative severe MR resolves in the majority of patients early on after LVAD implantation and is not associated with worse clinical outcomes or intermediate-term survival.

[Pedicled Omentum Flaps in the Management of Deep Sternal Wound Infections]. / Der gefäßgestielte Omentumlappen zur Behandlung tiefer sternaler Wundinfekte.

AIM: Coverage of a deep sternal wound infection with a greater omentum flap. Due to a persistent infection caused by an infected aortic prosthesis, the primarily performed reconstruction with a latissimus dorsi flap had to be revised, and an alternative solution had to be found. INDICATION: A deep sternal wound infection is a rare but devastating complication following median sternotomy. If the commonly used muscle flap is not sufficient and artificial material is still present in the wound, for instant drivelines or a vascular prosthesis, the greater omentum flap is a useful option due to its immunologic capacity. METHOD: After an exploration of the persisting infected deep sternal wound, a radical debridement is performed followed by a jet lavage. The soft tissue from the greater omentum is prepared via median laparotomy and transferred through a tunnel created in the diaphragm. Then it is pulled into the wound cavity and can be used for tension-free sheathing of the aortic prosthesis. The previously used muscle flap can additionally be used for superficial soft tissue coverage. CONCLUSION: Due to its immunologic competence, the greater omentum flap is a good treatment alternative to the commonly used muscle flaps in defects with infected artificial material.