Purpose:To advance minimally invasive surgical techniques, we developed the sutureless ELANA® End-to-End anastomotic technique. This preclinical study aimed to evaluate the technical feasibility, hemostatic performance, and short-term patency of the new approach in a porcine model. Methods:Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis. Results:The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15-45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology. Conclusion:The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time.

OBJECTIVES:The impact of minimally invasive surgical aortic valve replacement (SAVR) on long-term quality of life (QoL) is uncertain. This randomized controlled trial compared QoL 5 years after SAVR through upper hemisternotomy (UHS) or full median sternotomy. METHODS:Patients undergoing SAVR were randomized to UHS or full median sternotomy. The primary outcome was postoperative cardiac-specific QoL during 5 years, assessed by the Kansas City Cardiomyopathy Questionnaire physical limitations domain. Secondary outcomes include survival, other QoL domains, and factors associated with declined QoL between 1 and 5 years. RESULTS:Surgical aortic valve replacement via UHS resulted in better QoL as indicated by more favourable physical limitation and total symptoms scores (estimated mean difference [95% confidence interval] -1.89 [-2.93 to -0.85; P-value ≤.001] and 2.96 [-4.71 to -1.22; P-value = .016], respectively). Quality of life improvement persisted for 5 years, despite a decline after 1 year postoperative. Age and valve size smaller than or equal to 21 were independent predictors of decline in physical functioning, while full median sternotomy independently predicted declined total symptoms score. Five-year survival was 91.9% and similar between approaches (P-value = .417). CONCLUSIONS:Minimally invasive SAVR was associated with a modest but statistically significant improvement in cardiac-specific QoL over 5 years compared to median sternotomy, driven by earlier recovery, with comparable outcomes at 5 years. Full median sternotomy independently predicted decline in QoL demonstrated by decreased total symptom scores. CLINICAL REGISTRATION NUMBER:The Limited access Aortic valve Replacement trial is registered at ClinicalTrials.gov, number NCT04012060. Available via https://clinicaltrials.gov/study/NCT04012060.

OBJECTIVE:Coronary artery bypass surgery (CABG) is the most common technique in cardiac surgery. Distal anastomoses are currently almost exclusively hand-sewn, which limits the widespread implementation of less-invasive approaches. The aim of this trial is to investigate the safety and effectiveness of the excimer laser-assisted nonocclusive anastomosis (ELANA) device to construct distal anastomoses in CABG. METHODS:This study is a single-center, single-arm, prospective trial. Eligible patients were included from June 2023 to August 2024. The left internal thoracic artery (LITA) to left anterior descending (LAD) anastomosis was constructed using the ELANA anastomotic system, with additional hand-sewn anastomoses if required. The primary outcome was device-related major adverse cardiac events (MACE; consisting of cardiac death, and myocardial infarction [MI] or repeat revascularization of the LAD territory) at 1 year. Secondary outcomes included 6-month LITA patency assessed by coronary angiography defined by FitzGibbon (FG) criteria and 1-year overall MACE (composite death, MI, and repeat revascularization of all coronary artery territories). RESULTS:In total, 71 patients (89% male, aged 71.0 ± 6.5 years) were included. One-year device-related MACE was 2.9%, consisting of cardiac death and MI due to LITA failure, whereas overall MACE was 8.7%. Six-month LITA patency was 92.5%: FG criteria A 40.6%, B 51.6%, and O 7.8%. Intravascular ultrasound was performed in 6 patients with FG B, which revealed no significant stenosis. CONCLUSIONS:This trial demonstrates the safety and effectiveness of the ELANA device, but long-term follow-up is needed to confirm this. Trials are needed to investigate whether this device facilitates less-invasive approaches in CABG.

OBJECTIVES: Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement. METHODS: In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively. RESULTS: Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups. CONCLUSIONS: Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.

OBJECTIVES: Thoracoscopic ablation has proven to be an effective and safe rhythm control strategy, especially for persistent atrial fibrillation. However, its impact on quality of life (QoL) and potential gender differences remains unclear. METHODS: This prospective, single-centre observational study included consecutive patients with symptomatic atrial fibrillation undergoing thoracoscopic ablation. QoL was measured using the Short Form 36 (SF-36) and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires and longitudinal trend analysis including linear mixed models was used to assess gender-specific differences. RESULTS: A total of 191 patients were included; mean age 63.9 +/- 8.6 years, 61 (31.9%) women and 148 (77.5%) with non-paroxysmal atrial fibrillation. Women were older, more symptomatic and reported lower baseline QoL. AFEQT summary scores substantially improved after three months (relative increase 51.5% from baseline; P < 0.001) and persisted up to 1-year (57.2%; P < 0.001). Women showed substantial QoL improvement, which was comparable to men at 1 year. Distinct gender-related trajectories for AFEQT were observed. Women showed more often clinically important decline over time, yet AF recurrence and age were predictive factors in both men and women. Patients with AF recurrence also experienced QoL improvements, albeit to a lesser extent than those in sinus rhythm (61.3% vs 26.9%, P < 0.001), with no differences between men and women. CONCLUSIONS: Thoracoscopic ablation for atrial fibrillation results in substantial QoL improvement and was comparable for men and women. Understanding sex-specific and age-related trajectories is important to further enhance patient-centred atrial fibrillation care.

Background:Primary cardiac diffuse large B-cell lymphoma (CDLBCL) is an exceptionally rare entity, estimated to represent less than 1% of all primary cardiac tumours. In this case report, we emphasize the diagnostic importance of multimodality imaging and the need for additional procedures, such as tissue biopsy, in a case with a primary cardiac lymphoma presenting with cardiac tamponade. Case summary:An 80-year-old male was admitted to the emergency department with a life-threatening tamponade demanding immediate sternotomy. Pre-operative echocardiography unveiled pericardial effusion and a thickened apex. While computed tomography ruled out an aortic dissection, surgery revealed an unexpected vascular-rich mass at the right ventricle and apex, too perilous for biopsy. Post-operative imaging misinterpreted this mass as a benign haematoma. Subsequently, the patient was admitted to the intensive care unit, but after a conservative treatment strategy, the patient died. An autopsy revealed a primary CDLBCL. Discussion:This case demonstrates the deceptive nature of primary CDLBCL, often complicated by cardiac tamponade. It underscores the pivotal role of pathologic assessment, even amidst the perils of sternotomy, to determine the origin of abnormal cardiac masses. A heightened awareness among physicians is imperative, for such elusive diagnoses may slip by, with potentially fatal outcomes.

Objectives The ELANA® Heart Bypass creates a standardized sutureless anastomosis. Hereby, we investigate the influence of arteriotomy and graft size on coronary hemodynamics. Methods A computational fluid dynamics (CFD) model was developed. Arteriotomy size (standard 1.43 mm 2 ; varied 0.94 – 3.6 mm 2 ) and graft diameter (standard 2.5 mm; varied 1.5 – 5.0 mm) were independent parameters. Outcome parameters were coronary pressure and flow, and fractional flow reserve (FFR). Results The current size ELANA (arteriotomy 1.43 mm 2 ) presented an estimated FFR 0.65 (39 mL/min). Enlarging arteriotomy increased FFR, coronary pressure, and flow. All reached a maximum once the arteriotomy (2.80 mm 2 ) surpassed the coronary cross-sectional area (2.69 mm 2 , i.e. 1.85 mm diameter), presenting an estimated FFR 0.75 (46 mL/min). Increasing graft diameter was positively related to FFR, coronary pressure, and flow. Conclusion The ratio between the required minimal coronary diameter for application and the ELANA arteriotomy size effectuates a pressure drop that could be clinically relevant. Additional research and eventual lengthening of the anastomosis is advised. Graphical abstract

Interventricular septum defects are a known complication after an aortic valve replacement, but not after mitral surgery. We present a case of a 65-year-old female who underwent unsuccessful mitral valvuloplasty through port-access surgery, followed by uneventful mechanical bioprosthesis replacement. Postoperatively, the patient experienced multiple arrhythmias and recovered poorly. A systolic murmur led to echocardiography, showing an interventricular septum rupture. This was closed with 2 polypropylene pledgeted mattress sutures, via the right atrium and tricuspid valve through midsternal access. The authors believe that the most likely cause is tearing of 2 deeply placed adjacent sutures in the septum, creating localized weakening of the septum susceptible to further rupture. We therefore underline the importance of adequate exposure, especially at the notorious anterior annulus.

Background Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF. Methods CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues. Findings Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 +/- 7.9 years, mean LAD was 4.7 +/- 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75). Interpretation HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase. Funding AtriCure, Inc.

The disadvantages of mitral valve replacement with a bioprosthesis in the long-term may not play an important role if the shorter life expectancy of older patients is taken into account. This study aims to evaluate whether mitral valve replacement in the elderly is associated with similar outcome compared to repair in the short- and long-term. All patients aged 70 years and older undergoing minimally invasive mitral valve surgery were studied retrospectively. Primary outcome was 30-day complication rate, secondary outcome was long-term survival and freedom from re-operation. 223 Patients underwent surgery (124 replacement and 99 repair) with a mean age of 76.4 ± 4.2 years. 30-Day complication rate (replacement 73.4% versus repair 67.7%; p=.433), 30-day mortality (replacement 4.0% versus repair 1.0%; p=.332) and 30-day stroke rate (replacement 0.0% versus repair 1.0%; p=.910) were similar in both groups. Multivariable cox regression revealed higher age, diabetes and left ventricular dysfunction as predictors for reduced long-term survival, while a valve replacement was no predictor for reduced survival. Sub analysis of patients with degenerative disease showed no difference in long-term survival after propensity weighting (HR 1.4; 95%CI 0.84 – 2.50; p=.282). The current study reveals that mitral valve repair and replacement in the elderly can be achieved with good short- and long-term results. Long-term survival was dependent on patient related risk factors and not on the type of operation (replacement versus repair).

OBJECTIVES:In patients with deep sternal wound infection (DSWI), primary closure of the sternal bone over high negative pressure Redon drains has shown to be a safe and feasible treatment method. Addition of local gentamicin could accelerate healing and improve clinical outcomes. METHODS:We conducted a randomized controlled trial to evaluate the effectiveness of local gentamicin in the treatment of DSWI. In the treatment group, collagenous carriers containing gentamicin were left between the sternal halves during sternal refixation. In the control group, no local antibiotics were used. Primary outcome was hospital stay. Secondary outcomes were mortality, reoperation, wound sterilization time, time till removal of all drains and duration of intravenous antibiotic treatment. RESULTS:Forty-one patients were included in the trial of which 20 were allocated to the treatment group. Baseline characteristics were similar in both groups. Drains could be removed after a median of 8.5 days in the treatment group and 14.5 days in the control group (P-value: 0.343). Intravenous antibiotics were administered for a median of 23.5 days in the treatment group and 38.5 days in the control group (P-value: 0.343). The median hospital stay was 27 days in the treatment group and 28 days in the control group (P-value: 0.873). Mortality rate was 10% in the treatment group and 9.5% in the control group (P-value: 0,959). No side effects were observed. CONCLUSIONS:This randomized controlled trial showed that addition of local gentamicin in the treatment of DSWI did not result in shorter length of stay. CLINICAL TRIAL REGISTRATION NUMBER:2014-001170-33.

In this article, we describe the modified technique of a unilateral closed-chest thoracoscopic ablation and left atrial appendage closure including a box lesion that is made by radiofrequency clamps only for the treatment of atrial fibrillation. By abandoning the unidirectional pen devices and replacing these by radiofrequency clamps, we aim to further improve the procedural efficacy and shorten operation time while minimizing surgical exposure for the patient.

Minimally invasive mitral valve surgery (MIMVS) has become the standard approach for mitral valve pathology in many centres. The anterolateral mini thoracotomy access is beneficial in reoperative surgery by avoiding repeat sternotomy associated risks. The aim of this study is to analyse the safety of this technique. All patients undergoing reoperative MIMVS between 2008 and 2019 were studied retrospectively. Primary endpoint was 30-day major complications and mortality; secondary outcome was long term survival, reoperation rate and rate of more than moderate recurrent regurgitation. 146 Patients underwent reoperative MIMVS with a mean age of 68 ± 8 years. The composite outcome of 30-day major complication and mortality was 29.5%. 30-Day mortality was 6.2% and stroke rate 3.4%. Survival for the whole cohort was 89.7 ± 2.5% at 1-year, 71.6 ± 4.3% at 5 year and 50.9 ± 5.9% at 8-year follow up. Cox regression analysis revealed reduced left ventricular function (HR 2.8; 95%CI 1.5 - 5.0), GFR < 60 (HR 2.1; 95%CI 1.2 - 3.7) and active endocarditis (HR 6.4; 95%CI 2.7 - 15.4) as variables associated with reduced long-term survival. The cumulative incidence of re-operation after mitral valve replacement was 11.3 ± 3.2% at 5-year and for repair 16.2 ± 7.5% at 5-year. The cumulative incidence of more than moderate recurrent regurgitation after mitral valve repair was 25.4 ± 9.0% at 3-year. Minimally invasive access in reoperative mitral valve surgery in the current study showed similar 30-day mortality and stroke rate compared to repeat sternotomy results reported in literature.

Objective: The ELANA Heart Bypass System is a new sutureless technique for coronary anastomoses. A titanium clip connects the graft with the coronary artery, whereafter the arteriotomy is performed by excimer laser. Since this anastomotic construction evidently differs from the standard hand-sewn anastomosis, we aim to evaluate the process of anastomotic healing and remodeling. Methods: Preclinical evaluation of anastomotic remodeling in 42 pigs who underwent off-pump left internal mammary artery to left anterior descending artery anastomosis by either the ELANA Heart Bypass (n = 24) or the hand-sewn (n = 18) technique. Anastomotic remodeling was evaluated by scanning electron microscopy and histology in short-term follow-up intervals up to 3 months. Anastomotic patency is determined by coronary angiography at latest follow-up before termination. Results: The nonendothelial surface of both the ELANA and the hand-sewn anastomoses were covered with neointima from 14 days onwards. Only half the amount of intima hyperplasia was present in the anastomotic surface of the patent ELANA anastomosis, compared with the hand-sewn anastomosis (98 [48–1358] vs 218 [108–296] µm, P = 0.001). Yet patency of the ELANA was inferior to the hand-sewn anastomoses (79% vs 100%, P = 0.06). Conclusions: This study shows the technical perioperative feasibility of the ELANA Heart Bypass System. Although limited intima hyperplasia was observed, hand-sewn anastomoses had superior patency during follow-up. The results of this trial suggest that an additional study with a new prototype is required before clinical implementation.

Degenerative mitral regurgitation (DMR) based on posterior leaflet prolapse is the most frequent type of organic mitral valve disease and has proven to be durably repairable in most cases by chordal repair techniques either by conventional median sternotomy or by less invasive approaches both utilizing extracorporeal circulation and cardioplegic myocardial arrest. Recently, several novel transapical chordal repair techniques specifically targeting the posterior leaflet have been developed as a far less invasive and beating heart (off-pump) alternative to port-access mitral repair. In order to perform a safe and effective minimally invasive mitral chordal repair, thorough knowledge of the anatomy of the mitral valve apparatus and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, comprehensive understanding of the available novel devices, their delivery systems and the individual procedural steps are required.

Coronary artery disease is the most common type of cardiovascular disease, leading to high mortality rates worldwide. Although the vast majority can be treated effectively and safely by medical therapy, revascularization strategies remain essential for numerous patients. Outcomes of both percutaneous coronary intervention and coronary artery bypass grafting improve in a rapid pace, resulting from technical innovation and ongoing research. Progress has been achieved by technical improvements in coronary stents, optimal coronary target and graft selection, and the availability of minimally invasive surgical strategies. Besides technical progress, evidence-based patient-tailored decision-making by the Heart Team is the basic precondition for optimal outcome. The combination of fast innovation and long-term clinical evaluations creates a dynamic field. Research outcomes should be carefully interpreted according to the techniques used and the trial's design. Therefore, more and more trial outcomes suggest that revascularization strategies should be tailored towards the specific patient. Although the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization date from 2018 and a large variety of trial outcomes on revascularization strategies in chronic coronary syndrome have been published since, we aim to provide an updated overview within this review.

Objective This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. Methods Twenty Dutch Landrace pigs received either a hand-sewn ( n = 8) or an ELANA ( n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. Results The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. Conclusions The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.

2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)