Does Preoperative Sinus Rhythm Influence Surgical Ablation's Perioperative Safety in Patients with Atrial Fibrillation?

BACKGROUND: Despite excellent data on lowering long-term stroke and all-cause mortality rates, currently, only 25-40% of atrial fibrillation (AF) patients undergo simultaneous surgical ablation therapy (SA) during cardiac surgery. Surgeon's fear exposing their patients to an additional, unjustified, and disproportionate risk when performing SA in AF patients presenting with sinus rhythm (SR) before surgery. To clarify the influence of preoperative SR before SA for AF, we conducted a subgroup analysis of the German Cardiosurgical Atrial Fibrillation (CASE-AF) register. METHODS: Between September 2016 and August 2020, 964 AF patients with an underlying cardiac disease were scheduled for surgery with SA and enrolled in the CASE-AF register. Data prospectively were collected and analyzed retrospectively. We divided the entire cohort into an SR-group (38.2%, N = 368) and an AF-group (61.8%, N = 596), based on preoperative heart rhythm. RESULTS: Over half of the patients were moderately affected by their AF, with no difference between the groups (European Heart Rhythm Association class ≥IIb: SR-group 54.2% versus AF-group 58.5%, P = .238). The AF-group had a higher preoperative EuroSCORE II (4.8 ± 8.0% versus 4.2 ± 6.3%, P = .014). In-hospital mortality (SR-group 0.8% versus AF-group 1.7%, P = .261), major perioperative adverse cardiac and cerebrovascular events (SR-group 2.7% versus AF-group 3.5%, P = .500), and the new pacemaker implantation rate (SR-group 6.0% versus AF-group 5.9%, P = .939) were low and showed and no group difference. Logistic regression analysis showed a protective effect for preoperative SR to perioperative complications in AF patients undergoing SA (odds ratio (OR) 0.72 (95% CI 0.52 - 0.998); P = .0485). CONCLUSIONS: Concomitant SA in AF patients presenting in SR before cardiac surgery is safe, has a low perioperative risk profile, and should be carried out with almost no exceptions.

What will surgical coronary revascularization look like in 25 years?

PURPOSE OF REVIEW: Coronary artery bypass grafting evolved in incremental but significant steps since its introduction. Here, we provide an update on operative techniques, choice of conduits, patient selection/decision-making and primary and secondary prevention measures with potential of influencing the future of coronary artery bypass grafting (CABG) surgery. RECENT FINDINGS: Associated mortality of off-pump CABG (OPCAB) procedures performed in high-volume OPCAB centers (≥164 cases per year) and by experienced surgeons (≥48 cases per year) was reduced compared with on-pump CABG with two or more grafts suggesting a volume-based dependency of outcomes in CABG procedures with high-technical complexity. Ten-year results from the recent Arterial Revascularization Trial showed no significant between-group difference for the primary and secondary outcome. Total arterial revascularization using composite bilateral internal mammary artery-Y-conduits through a limited access mini-thoracotomy was not only shown to be feasible but a safe and reproducible procedure with excellent midterm outcomes. The most recent Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass (REGROUP) trial demonstrated no significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the occurrence of major adverse cardiac events. SUMMARY: Adherence to the most recent guidelines on myocardial revascularization is a key component for providing state-of the CABG surgery. Trends to lesser invasiveness in surgical coronary revascularization will gain momentum and is expected - with further improvements - to be the mainstay of future surgical coronary revascularization strategies.

Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery.

Aims: Left atrial appendage (LAA) occlusion has emerged as an interesting alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). We report the safety, efficacy, and durability of concomitant device-enabled epicardial LAA occlusion during open-heart surgery. In addition to long-term follow-up, we evaluate the impact on stroke risk in this selected population. Methods and results: A total of 291 AtriClip devices were deployed epicardially in patients (mean CHA2DS2-VASc-Score: 3.1 ± 1.5) undergoing open-heart surgery (including isolated coronary artery bypass grafting, valve, or combined procedures) comprising of forty patients from a first-in-man device trial (NCT00567515) and 251 patients from a consecutive institutional registry thereafter. In all patients (n = 291), the LAA was successfully excluded and overall mean follow-up (FU) was 36 ± 23months (range: 1-97 months). No device-related complications were detected throughout the FU period. Long-term imaging work-up (computed tomography) in selected patients ≥5years post-implant (range: 5.1-8.1 years) displayed complete LAA occlusion with no signs of residual reperfusion or significant LAA stumps. Subgroup analysis of patients with discontinued OAC during FU (n = 166) revealed a relative risk reduction of 87.5% with an observed ischaemic stroke-rate of 0.5/100 patient-years compared with what would have been expected in a group of patients with similar CHA2DS2-VASc scores (expected rate of 4.0/100 patient-years). No strokes occurred in the subgroup with OAC. Conclusion: The long-term results from our first-in-man prospective human trial plus our institutional registry of epicardial LAA occlusion with the AtriClip in patients with AF undergoing cardiac surgery demonstrate the safety and durability of the procedure. In addition, our data are suggestive for the potential efficacy of LAA occlusion in reducing the incidence of stroke. If validated in future large randomized trials, routine LAA occlusion in patients undergoing cardiac surgery (with contraindications to treatment with oral anticoagulants) may represent a reasonable adjunct procedure to reduce the risk of future stroke. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00567515.

Clinical performance of a new bidirectional rotational mechanical lead extraction sheath.

AIMS: We investigated the safety and efficacy of a new bidirectional rotational mechanical extraction sheath (Evolution RL, Cook Medical, USA). METHODS AND RESULTS: From April 2013 until September 2014, we performed lead extraction procedures in 71 patients with 112 leads scheduled for extraction. During this time period, we used the new Evolution RL rotational sheath in 40 patients on 52 leads (24 pacemaker leads and 28 implantable cardioverter-defibrillator leads) scheduled for extraction. The mean lead implant duration in these patients was 100.2 (22-271) months. Forty leads were right ventricular leads, 10 right atrial leads, and 2 coronary sinus leads. Clinical success among the leads approached with the Evolution RL device was 98.1%. Operative mortality was zero. Major complications did not occur. Four minor complications were encountered (all pocket haematomas). No device-related complications were noted. In cases with multiple leads in situ, no wrapping of companion leads was seen. The average number of extraction tools used per lead was 2.4 (2-4) in the Evolution RL cohort. CONCLUSION: Based on the presented results of our initial experience with the new bidirectional rotational mechanical extraction device, its use is safe and efficient with high success rates in long implanted leads.

Survival, Neurologic Injury, and Kidney Function after Surgery for Acute Type A Aortic Dissection.

BACKGROUND: To analyze survival, neurologic injury, and kidney function after acute type A aortic dissection. METHODS: A total of 445 patients undergoing surgery for acute type A aortic dissection were analyzed. Evaluation according to risk factors for mortality, neurologic injury, and kidney function was performed. RESULTS: Overall 1-, 5-, and 10-year survival rates were 82.8 ± 1.8%, 73.6 ± 2.4%, and 59.3 ± 3.9, respectively. Independent preoperative risk factors for mortality were preexisting renal impairment (p = 0.001), reduced left ventricular ejection fraction (p < 0.001), and age (p < 0.001). Perioperative risk factors were prolonged cross-clamp (p < 0.001) and cerebral perfusion time (p = 0.001). Risk factors for renal failure were preexisting renal impairment (p < 0.001), prolonged cross-clamp time (p < 0.001), cerebral perfusion time (p < 0.001), and age (p = 0.022). Risk factors for neurologic injury were cross-clamp time (p = 0.038), cerebral perfusion time (p = 0.007), and age (p = 0.045). CONCLUSION: In addition to classic risk factors, survival after type A aortic dissection is affected by preexisting renal impairment. Preexisting renal impairment is predictive of postoperative renal failure. Therefore treatment and prevention strategies for renal failure during the acute and long-term course after acute type A aortic dissection are warranted.

The Potential Impact of Functional Imaging on Decision Making and Outcome in Patients Undergoing Surgical Revascularization.

OBJECTIVE: Coronary angiography (CA) remains the standard for preoperative planning for surgical revascularization. However, besides anatomical imaging, current guidelines recommend additional functional imaging before a therapy decision is made. We assess the impact of functional imaging on the strategy of coronary artery bypass grafting (CABG) with particular regards on postoperative patency and myocardial perfusion. METHODS: After CA, 55 patients (47 males/8 females; age: 65.1 ± 9.5 years) underwent perfusion cardiovascular magnetic resonance (CMR) and dual-source computed tomography (DSCT) before isolated CABG (n = 31), CABG and concomitant valve surgery (valve + CABG; n = 10) and isolated valve surgery (n = 14; control). DSCT was used for analysis of significant stenosis, CMR for myocardial-perfusion to discriminate between: no ischemia (normal), ischemia, or scar. The results, unknown to the surgeons, were compared with CA and related to the location and number of distal anastomoses. Nineteen CABG patients underwent follow-up CMR and DSCT (FU: 13 ± 3 months) to compare the preop findings with the postop outcomes. RESULTS: Thirty-nine patients either received CABG alone (n = 31) or a combined procedure (n = 10) with a total of 116 distal anastomoses. DSCT was compared with CA regarding accuracy of coronary stenosis and showed 91% sensitivity, 88% specificity, and negative/positive predictive values of 89/90%. In total, 880 myocardial segments (n = 55, 16 segments/patient) were assessed by CMR. In 17% (149/880) of segments ischemia and in 8% (74/880) scar tissue was found. Interestingly, 14% (16/116) of bypass-anastomoses were placed on non-ischemic myocardium and 3% (4/116) on scar tissue. In a subgroup of 19 patients 304 segments were evaluated. Thirty-nine percent (88/304) of all segments showed ischemia preoperatively, while 94% (83/88) of these ischemic segments did not show any ischemia postoperatively. In regard to performed anastomoses, 79% of all grafts (49/62) were optimally placed, whereas 21% (13/62) were either placed into non-ischemic myocardium or scar tissue, including 10% occluded grafts (6/62). CONCLUSION: In the whole cohort analysis, 17% of grafts were placed in regions with either no ischemia or scar tissue. The subgroup analysis revealed that 94% of all ischemic segments were successfully revascularized after CABG. Thus, functional imaging could be a promising tool in preoperative planning of revascularization strategy. Avoidance of extensive and unnecessary grafting could further optimize outcomes after CABG.

Use of extracellular matrix patches in cardiac surgery.

A noncellular xenogeneic extracellular matrix derived from the porcine small intestinal submucosa can be used as a new patch material with potential advantages. We review the literature on the use of this material in cardiac surgery.

Does implantation technique influence lead failure?

OBJECTIVE: We aimed to analyse whether different lead implantation techniques influence lead failure based on implant duration. METHODS AND RESULTS: Eighty-two transvenous leads were extracted due to lead failure. Median implant duration (MID) of the extracted leads was 68 months. Failed leads were retrospectively divided into 5 subgroups according to predefined technical procedural aspects, potentially triggering lead failure: venous approach, lead disorder in the generator pocket, sharp lead angulation, lead-lead interaction and number of leads in situ. The subgroups were correlated to the MID and compared. The MID was 81 vs 59 months in medial vs lateral venous puncture (P=0.453). In subgroups without/with lead disorder the MID was 59 vs 107 months (P=0.006) and 57 vs 84 months (P=0.012) in subgroups without/with sharp lead angulation, respectively. In subgroups without/with more than 1 lead-lead interaction the MID was 59 vs 81 months (P=0.029) and 65 vs 86 months (P=0.128) without/with more than 2 lead-lead interactions, respectively. In subgroups without/with more than 1 lead in situ the MID was 73 vs 67 months (P=0.453), 81 vs 27 months (P=0.296) in subgroups without/with more than 2 leads in situ and 68 vs 77 months (P=0.264) in subgroups without/with more than 3 leads in situ, respectively. CONCLUSIONS: Although, we were able to confirm our hypothesis only partially, technical aspects of lead implantation technique should be kept in mind as a potential reason causing lead failure.

Repair rate and durability of video assisted minimally invasive mitral valve surgery.

BACKGROUND: Minimally invasive mitral valve surgery (MIMVS) through a right lateral thoracotomy has emerged as another option in cardiac surgery. We present our single center experience with regards to repair rate and durability of the repair in patients undergoing MIMVS. METHODS: Between January 2009 and December 2012 a total of 312 consecutive patients underwent MIMVS. Baseline characteristics, operative variables, postoperative outcomes, and follow-up information about survival, major adverse cardiac and cerebrovascular event (MACCE)-free survival, valve competence, and freedom from reoperation were collected. RESULTS: Mean age was 61 ± 13.1 years, median Euroscore 4 (0-13). The predominant valve pathology was degenerative disease (96.2%) with regurgitation (95.2%) and atrial fibrillation (23.1%). Bypass time was 147 ± 46, cross-clamp time 94 ± 32 minutes. All degenerative valves planned for repair (n = 281) were successfully repaired except for two (0.7%) resulting in a 99.3% repair rate. Eight patients (2.8%) had to be converted to sternotomy. Median ventilation time was 6.6 hours (0 to 460), ICU stay one day (0 to 96), and hospital stay eight days (3 to 61). Most of the patients did not need red blood cell transfusion (78.2%). One patient died in hospital due to acute respiratory distress syndrome (0.3%) and five suffered a permanent stroke (1.6%). In 294 patients (94.5%) follow-up was completed for a median of 22 months (0 to 53) with 95.5 ± 1.2% overall survival, 96.8 ± 1.2%, MACCE-free survival, and 94.8 ± 0.1% freedom from reoperation. CONCLUSIONS: MIMVS is a safe approach with low morbidity and mortality that allows a high and durable repair rate with low reoperation rates and favorable short-term event-free survival.

Consensus statement-graft treatment in cardiovascular bypass graft surgery.

Coronary artery bypass grafting (CABG) is and continues to be the preferred revascularization strategy in patients with multivessel disease. Graft selection has been shown to influence the outcomes following CABG. During the last almost 60 years saphenous vein grafts (SVG) together with the internal mammary artery have become the standard of care for patients undergoing CABG surgery. While there is little doubt about the benefits, the patency rates are constantly under debate. Despite its acknowledged limitations in terms of long-term patency due to intimal hyperplasia, the saphenous vein is still the most often used graft. Although reendothelialization occurs early postoperatively, the process of intimal hyperplasia remains irreversible. This is due in part to the persistence of high shear forces, the chronic localized inflammatory response, and the partial dysfunctionality of the regenerated endothelium. "No-Touch" harvesting techniques, specific storage solutions, pressure controlled graft flushing and external stenting are important and established methods aiming to overcome the process of intimal hyperplasia at different time levels. Still despite the known evidence these methods are not standard everywhere. The use of arterial grafts is another strategy to address the inferior SVG patency rates and to perform CABG with total arterial revascularization. Composite grafting, pharmacological agents as well as latest minimal invasive techniques aim in the same direction. To give guide and set standards all graft related topics for CABG are presented in this expert opinion document on graft treatment.

Outcomes after surgical revascularization in diabetic patients.

OBJECTIVES: Patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) have been repeatedly demonstrated to have worse clinical outcomes compared to patients without DM. The objective of this study was to evaluate the impact of DM on 1-year clinical outcomes after isolated CABG. METHODS: The European DuraGraft registry included 1130 patients (44.6%) with and 1402 (55.4%) patients without DM undergoing isolated CABG. Intra-operatively, all free venous and arterial grafts were treated with an endothelial damage inhibitor. Primary end point in this analysis was the incidence of a major adverse cardiac event (MACE), a composite of all-cause death, repeat revascularization or myocardial infarction at 1 year post-CABG. To balance between differences in baseline characteristics (n = 1072 patients in each group), propensity score matching was used. Multivariable Cox proportional hazards regression was performed to identify independent predictors of MACE. RESULTS: Diabetic patients had a higher cardiovascular risk profile and EuroSCORE II with overall more comorbidities. Patients were comparable in regard to surgical techniques and completeness of revascularization. At 1 year, diabetics had a higher MACE rate {7.9% vs 5.5%, hazard ratio (HR) 1.43 [95% confidence interval (CI) 1.05-1.95], P = 0.02}, driven by increased rates of death [5.6% vs 3.5%, HR 1.61 (95% CI 1.10-2.36), P = 0.01] and myocardial infarction [2.8% vs 1.4%, HR 1.99 (95% CI 1.12-3.53) P = 0.02]. Following propensity matching, no statistically significant difference was found for MACE [7.1% vs 5.7%, HR 1.23 (95% CI 0.87-1.74) P = 0.23] or its components. Age, critical operative state, extracardiac arteriopathy, ejection fraction ≤50% and left main disease but not DM were identified as independent predictors for MACE. CONCLUSIONS: In this study, 1-year outcomes in diabetics undergoing isolated CABG were comparable to patients without DM.

Surgical ablation of long-standing persistent atrial fibrillation: 1-year outcomes from the CArdioSurgEry Atrial Fibrillation (CASE-AF) registry.

OBJECTIVES: The CArdioSurgEry Atrial Fibrillation (CASE-AF) registry is a prospective, multicentre study for collecting and analysing real-world data of surgical atrial fibrillation (AF) treatment. This study aimed to evaluate outcomes of surgery for long-standing persistent AF at 1 year. METHODS: In total, 17 centres consecutively include all eligible patients with continuous AF lasting for ≥1 year. Exclusion criteria are missing informed consent or age <18 years. For patient-reported outcomes measures, the European Heart Rhythm Association score was used. No presence of AF (based on ECG findings including Holter ECG and/or implanted devices), no re-ablation, no further cardioversion and no rehospitalization due to AF after a 3-month blanking period defined no AF recurrence at 1 year. RESULTS: From January 2017 to January 2020, a total of 1115 patients were enrolled in CASE-AF. Of them, 202 patients (mean age 69.7 ± 7.8 years, 27.2% female) underwent surgical ablation of long-standing persistent AF (study cohort), mostly accompanied by left atrial appendage closure (n = 180 [89%], resection n = 75 [42%]) and predominantly performed as concomitant (n = 174 [86%]) and left atrial only procedure (n = 144 [71%]). Early mortality (30 days) was 2.0% and morbidity was low. At follow-up (median 14.4 months, interquartile range, 12.7-17.6 months, 100% complete), 106 patients (56%) had no AF recurrence and 93% of them were asymptomatic. AF recurrence was accompanied by AF-related rehospitalization (n = 12, P = 0.003), direct current shock cardioversion (n = 23, P < 0.001), AF ablation (n = 7, P = 0.003) and stroke (n = 3, P = 0.059). Multivariable analysis identified cryoablation, predominantly performed endocardially including additional left atrial (74%) and biatrial (42%) lesions, as a significant factor for freedom from AF recurrence (odds ratio 2.7, 95% confidence interval 1.07-6.79, P = 0.035). CONCLUSIONS: According to CASE-AF, surgical ablation of long-standing persistent AF is most effective when concomitantly performed using endocardial cryoablation. Ongoing follow-up allows further elucidation of efficacious treatment strategies.

Endothelial damage inhibitor preserves the integrity of venous endothelial cells from patients undergoing coronary bypass surgery.

OBJECTIVES: Despite the success of coronary artery bypass graft (CABG) surgery using autologous saphenous vein grafts (SVGs), nearly 50% of patients experience vein graft disease within 10 years of surgery. One contributing factor to early vein graft disease is endothelial damage during short-term storage of SVGs in inappropriate solutions. Our aim was to evaluate the effects of a novel endothelial damage inhibitor (EDI) on SVGs from patients undergoing elective CABG surgery and on venous endothelial cells (VECs) derived from these SVGs. METHODS: SVGs from 11 patients participating in an ongoing clinical registry (NCT02922088) were included in this study, and incubated with both full electrolyte solution (FES) or EDI for 1 h and then examined histologically. In 8 of 11 patients, VECs were isolated from untreated grafts, incubated with both FES and EDI for 2 h under hypothermic stress conditions and then analysed for activation of an inflammatory phenotype, cell damage and cytotoxicity, as well as endothelial integrity and barrier function. RESULTS: The EDI was superior to FES in protecting the endothelium in SVGs (74 ± 8% versus 56 ± 8%, P < 0.001). Besides confirming that the EDI prevents apoptosis in SVG-derived VECs, we also showed that the EDI temporarily reduces adherens junctions in VECs while protecting focal adhesions compared to FES. CONCLUSIONS: The EDI protects the connectivity and function of the SVG endothelium. Our data suggest that the EDI can preserve focal adhesions in VECs during short-term storage after graft harvesting. This might explain the superiority of the EDI in maintaining most of the endothelium in venous CABG surgery conduits.

Clinical outcomes and quality of life after contemporary isolated coronary bypass grafting: a prospective cohort study.

OBJECTIVES: The objective of the European Multicenter Registry to Assess Outcomes in coronary artery bypass grafting (CABG) patients (DuraGraft Registry) was to determine clinical outcomes and quality of life (QoL) after contemporary CABG that included isolated CABG and combined CABG/valve procedures, using an endothelial damage inhibitor (DuraGraft) intraoperatively for conduit preservation. Here, we report outcomes in the patient cohort undergoing isolated CABG. METHODS: The primary outcome was the composite of all-cause death, myocardial infarction (MI), or repeat revascularization (RR) [major adverse cardiac events (MACE)] at 1 year. Secondary outcomes included the composite of all-cause death, MI, RR, or stroke [major adverse cardiac and cerebrovascular events (MACCE)], and QoL. QoL was assessed with the EuroQol-5 Dimension questionnaire. Independent risk factors for MACE at 1 year were determined using Cox regression analysis. RESULTS: A total of 2532 patients (mean age, 67.4±9.2 years; 82.5% male) underwent isolated CABG. The median EuroScore II was 1.4 [interquartile range (IQR), 0.9-2.3]. MACE and MACCE rates at 1 year were 6.6% and 7.8%, respectively. The rates of all-cause death, MI, RR, and stroke were 4.4, 2.0, 2.2, and 1.9%, respectively. The 30-day mortality rate was 2.3%. Age, extracardiac arteriopathy, left ventricular ejection fraction less than 50%, critical operative state, and left main disease were independent risk factors for MACE. QoL index values improved from 0.84 [IQR, 0.72-0.92] at baseline to 0.92 [IQR, 0.82-1.00] at 1 year ( P <0.0001). CONCLUSION: Contemporary European patients undergoing isolated CABG have a low 1-year clinical event rate and an improved QoL.

Clinical event rate in patients with and without left main disease undergoing isolated coronary artery bypass grafting: results from the European DuraGraft Registry.

OBJECTIVES: Left main coronary artery disease (LMCAD) is considered an independent risk factor for clinical events after coronary artery bypass grafting (CABG). We have conducted a subgroup analysis of the multicentre European DuraGraft Registry to investigate clinical event rates at 1 year in patients with and without LMCAD undergoing isolated CABG in contemporary practice. METHODS: Patients undergoing isolated CABG were selected. The primary end point was the incidence of a major adverse cardiac event (MACE) defined as the composite of death, myocardial infarction (MI) or repeat revascularization (RR) at 1 year. The secondary end point was major adverse cardiac and cerebrovascular events (MACCE) defined as MACE plus stroke. Propensity score matching was performed to balance for differences in baseline characteristics. RESULTS: LMCAD was present in 1033 (41.2%) and absent in 1477 (58.8%) patients. At 1 year, the MACE rate was higher for LMCAD patients (8.2% vs 5.1%, P = 0.002) driven by higher rates of death (5.4% vs 3.4%, P = 0.016), MI (3.0% vs 1.3%, P = 0.002) and numerically higher rates of RR (2.8% vs 1.8%, P = 0.13). The incidence of MACCE was 8.8% vs 6.6%, P = 0.043, with a stroke rate of 1.0% and 2.4%, P = 0.011, for the LMCAD and non-LMCAD groups, respectively. After propensity score matching, the MACE rate was 8.0% vs 5.2%, P = 0.015. The incidence of death was 5.1% vs 3.7%, P = 0.10, MI 3.0% vs 1.4%, P = 0.020, and RR was 2.7% vs 1.6%, P = 0.090, for the LMCAD and non-LMCAD groups, respectively. Less strokes occurred in LMCAD patients (1.0% vs 2.4%, P = 0.017). The MACCE rate was not different, 8.5% vs 6.7%, P = 0.12. CONCLUSIONS: In this large registry, LMCAD was demonstrated to be an independent risk factor for MACE after isolated CABG. Conversely, the risk of stroke was lower in LMCAD patients. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02922088.

Endothelial damage inhibitors for improvement of saphenous vein graft patency in coronary artery bypass grafting.

The saphenous vein graft (SVG) remains the most commonly used conduit in coronary artery bypass grafting (CABG). In light of this further research must be aimed at the development of strategies to optimize SVG patency and thereby improve both short- and long-term outcomes of CABG surgery. SVG patency in large part depends on the protection of the structural and functional integrity of the vascular endothelium at the time of conduit harvesting, including optimal storage conditions to prevent endothelial damage. This review provides an overview of currently available storage and preservation solutions, including novel endothelial damage inhibitors, and their role in mitigating endothelial damage and vein graft failure.

Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model.

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.