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OBJECTIVE A multidisciplinary heart valve team is recommended for the evaluation of treatment in patients with valvular heart disease, but evidence supporting this concept is lacking. In patients with severe mitral regurgitation, we thought to analyse the patient selection process by the heart team for different treatment options and the outcome after treatment. METHODS In this single-centre cohort study, all patients treated for mitral regurgitation between July 2013 and September 2018 were included. Primary end points during follow-up were all-cause mortality and a combined end point, consisting of all-cause mortality, cardiovascular rehospitalisation and mitral valve reintervention. RESULTS 179 patients (44.8%) were treated using Mitraclip, 185 (46.2%) by surgical repair and 36 (9.0%) by surgical replacement. The mortality risk according to EuroScore II differed significantly between treatment groups (6.6%±5.6%, 1.7%±1.5% and 3.6%±2.7% for Mitraclip, surgical repair and replacement, respectively, p<0.001). In-hospital mortality for the 3 groups were 3.4%, 1.6% and 8.3%, respectively (p=0.091). Overall, surgical repair patients had higher 4-year survival (HR 0.40 (95% CI 0.26 to 0.63), p<0.001) and fewer combined end points (HR 0.51 (95% CI 0.32 to 0.80), p<0.001) compared with surgical replacement and Mitraclip patients. However, patients undergoing Mitraclip for isolated, primary mitral regurgitation achieved very good long-term survival. CONCLUSION The multidisciplinary heart team assigned only low-risk patients with favourable anatomy to surgical repair, while high-risk patients underwent Mitraclip or surgical replacement. This strategy was associated with lower than expected in-hospital mortality for Mitraclip patients and high 4-year survival rates for patients undergoing surgical or percutaneous repair of isolated primary mitral regurgitation.

BACKGROUND Left atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation. We evaluate a novel device for epicardial LAAO in a translational canine model. METHODS Nine hounds (n = 9) were used to assess usability, safety, and efficacy of the TigerPaw Pro (TPP) device for epicardial LAAO. Following baseline imaging (intra-cardiac echocardiography (ICE) and angiography) and intraoperative visual inspection, usability was tested via a ``closure/re-opening`` maneuver followed by deployment of a total of twenty TPP devices (n = 20) on the left and right atrial appendages respectively. Procedural safety was evaluated by assessing for adverse-events via direct Epicardial inspection and endocardial imaging. Efficacy evaluation included assessment of device positioning, presence of residual stumps and completeness of closure. Post-mortem evaluation was performed to confirm safety and efficacy. RESULTS Usability testing of all TPP devices was successful (n = 20;100%, delivery-time range 22-120 s) without any procedural adverse-events (tissue damage or tears, bleeding, vessel-impingement, structural impact). All devices fully traversed the ostium (n = 18) or appendage body (n = 2), and conformed smoothly to adjacent cardiac anatomy. In nineteen deployments (n = 19;95%), all device connector pairs were fully engaged, while in one TPP device the most distal pair remained unengaged. ICE and post-mortem inspections revealed complete closure of all appendage ostia (n = 18;100%) and only in one case a small residual stump was detected. Intraoperative safety findings were further confirmed post-mortem. Devices created a nearly smooth line of closure via symmetric endocardial tissue-coaptation. CONCLUSIONS In this preclinical model, the TPP demonstrated good ease of use for ostial access, ability to re-position (after engagement) and rapid deployment, while achieving safe and effective LAAO.

Background:Traditional surgical treatment for patients with atrial fibrillation (AF) is performed via sternotomy and on cardiopulmonary bypass. It is very effective in regard to rhythm control, but remains unpopular due to its invasiveness. Truly endoscopic AF treatments have decreased the threshold for electrophysiologists (and cardiologists) to refer, and the reluctance of patients to accept a standalone surgical approach. Practice guidelines from around the world have recognized this as an acceptable therapeutic approach. Current guidelines recommend the HeartTeam approach in treating these complex AF cases. In this study we report our experience with AF HeartTeam approach for surgical stand-alone AF ablation. Methods: The AF HeartTeam Program began in 2013, patients qualified for inclusion if either of the following was present: failed catheter ablation and/or medication, not suitable for catheter ablation, contraindication to anticoagulation, or patients preferring such an approach. All patients with a complex AF history were assessed by the AF HeartTeam, from which 42 patients were deemed suitable for a totally endoscopic AF procedure (epicardial ablation and LAA closure). Endpoints were intraoperative bidirectional block of the pulmonary veins and closure of left atrial appendage confirmed by transesophageal echocardiography (TEE). Post discharge rhythm follow-up was performed after 3 and 12, 24 and 36 months. Anticoagulation was discontinued 6 weeks after the procedure in patients after documented LAA closure. Results: In total 42 patients underwent the endoscopic procedure (Median CHA2DS2-VASC=3 (1-6), HAS-BLED=2 (1-6)) for paroxysmal (15/42) and non-paroxysmal AF (27/42) respectively. Bidirectional block was obtained in all patients and complete LAA closure was obtained in all but one Patient on TEE (41/42). In one patient the LAA was not addressed due to extensive adhesions. Two patients underwent median sternotomy because of bleeding during the endoscopi

OBJECTIVES Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery. METHODS Forty patients with AF were enrolled in this prospective ‘first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation procedure was planned. Intraoperative transoesophageal echocardiography (TEE) was used to exclude LAA thrombus at baseline and evaluate LAA perfusion after the procedure, while computed tomography (CT) was used for serial imagery workup at baseline, 3-, 12-, 24- and 36-month follow-up. RESULTS Early mortality was 10% due to non-device-related reasons, and thus 36 patients were included in the follow-up consisting of 1285 patient-days and mean duration of 3.5 ± 0.5 years. On CT, clips were found to be stable, showing no secondary dislocation 36 months after surgery. No intracardial thrombi were seen, none of the LAA was reperfused and in regard to LAA stump, none of the patients demonstrated a residual neck >1 cm. Apart from one unrelated transient ischaemic attack (TIA) that occurred 2 years after surgery in a patient with carotid plaque, no other strokes and/or neurological events demonstrated in any of the studied patients during follow-up. CONCLUSION This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy for s

Objective: Diabetic patients often present with diffuse coronary disease than nondiabetic patients posing a greater surgical challenge during off-pump revascularization. In this study, the safety, feasibility, and completeness of revascularization for this subset of patients was assessed. Methods: From 2002 to 2008, 1015 diabetic patients underwent myocardial revascularization. Patients received either off-pump coronary artery bypass (OPCAB; n=540; 53%) or coronary artery bypass grafting (CABG; n=475; 47%). Data collection was performed prospectively and data analysis was done by propensity-score (PS)-adjusted regression analysis. Primary endpoints were mortality, major adverse cardiac and cerebrovascular events (MACCEs), and a composite endpoint including major noncardiac adverse events (MNCAEs) such as respiratory failure, renal failure, and rethoracotomy for bleeding was applied. An index of complete revascularization (ICOR) was defined to assess complete revascularization by dividing the total number of distal anastomoses by the number of diseased vessels. Complete revascularization was assumed when ICOR was >1. Results: OPCAB patients had a significantly lower mortality-rate (1.1% vs 3.8%; propensity-adjusted odds ratio (PAOR)=0.11; p=0.018) and displayed less frequent MACCE (8.3% vs 17.9%; PAOR=0.66; p=0.07) including myocardial infarction (1.3% vs 3.2%; PAOR=0.33; p=0.06) and stroke (0.7% vs 2.3%; PAOR=0.28; p=0.13). Similarly, a significantly lower occurrence of the noncardiac composite endpoint (MNCAE) (PAOR=0.46; confidence interval (CI) 95% 0.35-0.91; p<0.001) was detected. In particular, lesser respiratory failure (0.9% vs 4.3%; PAOR=0.24; p=0.63) and pleural effusions (3.3% vs 7.5%; PAOR=0.45; p=0.04) occurred, so that fast extubation (≤12h postoperative) was more frequently possible (58.3% vs 34.2%; PAOR=1.64; p=0.007). The number of arterial grafts was significantly higher among OPCAB patients (1.54±0.89 vs 1.33±0.81; p=0.006) due to a more frequent u

Objective: Pulmonary hypertension (PH) and elevated pulmonary vascular resistance (PVR) lead to poor outcome after heart transplantation due to postoperative failure of the non-conditioned right ventricle. The role of continuous flow left ventricular assist device (LVAD) support in the reduction of elevated PVR was evaluated in a series of clinical implants. Methods: Among 17 patients with terminal heart failure receiving a MicroMed DeBakey LVAD as bridge to transplant, there were six patients with pulmonary hypertension (mean systolic PAP 47mmHg) and high PVR (398dynes/cm5), previously not considered suitable for heart transplantation, who underwent serial right heart catheters during their LVAD support period. Results: In these patients mean systolic pulmonary pressure dropped to 29mmHg and PVR decreased to a mean 167dynes/cm5 under LVAD support. Clinical improvement was significant in all patients. Four patients were successfully transplanted without major postoperative difficulties (mean duration 130 days support) and all are doing well to date. Post-transplant-PVR remained in the normal range in all transplanted patients. Conclusions: Elevated PVR and severe PH were both previously considered as contraindication for heart transplantation. A period of LVAD pumping leads to a progressive decrease of PVR and normalization of pulmonary pressures, making these patients amenable for heart transplantation. LVAD as bridge to heart transplantation is safe and highly beneficial for terminal heart failure patients with severe PH

Objective: Management of the left atrial appendage (LAA) is considered an important adjunct to ablation in cardiac surgical patients with atrial fibrillation (AF). However, current surgical techniques, both cut-and-sew and stapling, have been associated with incomplete LAA occlusion and complications. Using cardiac magnetic resonance imaging (MRI), we studied the safety and effectiveness of a new device for LAA occlusion in a primate model. Methods: Seven adult baboons underwent off-pump placement of an LAA clip (AtriCure Inc., Westchester, Ohio). LAA occlusion was confirmed intraoperatively by direct incision. All animals had MRI before and after clip placement to assess LAA perfusion, architecture, and overall cardiac function. Pathologic and histological studies were performed at 7, 30 and 180 days. Results: Clip placement was successful in all (n=7) without any clip related complications. Complete LAA occlusion was demonstrated intraoperatively in all subjects. LAA occlusion was confirmed on pre-sacrifice MRI, and left and right ventricular function were unchanged from preoperative studies; however, clip placement caused small reductions in left ventricular end-diastolic, end-systolic, and stroke volumes. At sacrifice, direct inspection confirmed stable location, persistent LAA exclusion, tissue in-growth and homogenous epithelialization without damage to adjacent structures. Histological analysis revealed a regular in-growth pattern in all studied specimens. Conclusion: We demonstrated a safe, straightforward, persistent and effective method for LAA occlusion with this new LAA clip. MRI effectively demonstrated LAA occlusion and only minor changes in left ventricular volumes

We describe the case of a patient implanted with a DeBakey left ventricular assist device (LVAD) as bridge to transplant who survived 7 h of ventricular fibrillation. He was successfully converted into a stable sinus rhythm

OBJECTIVES The combination of aortic ‘no-touch' off-pump surgery (OPCAB) and total arterial revascularization (TAR) can reduce peri-procedural morbidity and yields excellent long-term outcomes albeit at a reported risk of incomplete revascularization. The feasibility of OPCAB-TAR with specific regards to the complete revascularization (CR) in patients with multi-vessel disease was evaluated. METHODS From 2003 to 2010, 712 patients underwent TAR including 526 patients who had OPCAB-TAR and 186 patients who received on-pump TAR [(ONCAB grafting (ONCABG)-TAR)]. Of these, 52% (n=272; OPCAB) vs. 83% (n=155; ONCABG) had triple-vessel disease (TVD). To balance patient characteristics, a non-parsimonious, propensity score (PS) model was applied. Endpoints evaluated were mortality, stroke, major adverse cardiac and cerebrovascular events (MACCE). To evaluate CR, an ‘Index of CR' (ICOR) was calculated, defined as the number of distal anastomoses divided by the number of the diseased coronary vessels. CR was assumed when the following requirements were fulfilled: the number of distal anastomoses was equal to or higher than that of diseased vessels (ICOR≥1), and all affected coronary territories (left anterior descending, circumflex artery and/or right coronary artery) were grafted. RESULTS Mortality was comparable between groups, whereas OPCAB patients suffered from significantly decreased rates of MACCE [3.0 vs. 7.0%; propensity-adjusted odd ratio (PAOR)=0.24; confidence interval (CI) 95% 0.08-0.66; P=0.006] including a clear trend towards reduced stroke and myocardial infarction. In the subgroup with TVD, OPCAB patients presented with significantly reduced rates for MACCE (1.8 vs. 5.8%; PAOR=0.07; CI 95% 0.01-0.65; P=0.02), including a significantly lower rate for stroke. For all-comers, the number of diseased vessels was lower after OPCAB (2.36±0.73 vs. 2.87±0.39; P<0.001) and consequently, these patients received an overall lower number of distal anastomoses (2.42±1.15 vs.

OBJECTIVES: Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery. METHODS: Forty patients with AF were enrolled in this prospective 'first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation procedure was planned. Intraoperative transoesophageal echocardiography (TEE) was used to exclude LAA thrombus at baseline and evaluate LAA perfusion after the procedure, while computed tomography (CT) was used for serial imagery workup at baseline, 3-, 12-, 24- and 36-month follow-up. RESULTS: Early mortality was 10% due to non-device-related reasons, and thus 36 patients were included in the follow-up consisting of 1285 patient-days and mean duration of 3.5 ± 0.5 years. On CT, clips were found to be stable, showing no secondary dislocation 36 months after surgery. No intracardial thrombi were seen, none of the LAA was reperfused and in regard to LAA stump, none of the patients demonstrated a residual neck >1 cm. Apart from one unrelated transient ischaemic attack (TIA) that occurred 2 years after surgery in a patient with carotid plaque, no other strokes and/or neurological events demonstrated in any of the studied patients during follow-up. CONCLUSION: This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy f