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.

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.

Transvenous lead extractions: comparison of laser vs. mechanical approach.

AIMS: In this retrospective study we compared different lead extraction techniques. METHODS AND RESULTS: Between January 2009 and December 2012 we performed transvenous lead extraction procedures on 206 leads in 122 patients. Mean implant duration (MID) was 69.6 months (1-384 months). Leads with lead implant duration ≥ 12 months were assigned to groups according to the extraction technique: Group A: no extraction tool; Group B: laser approach; and Group C: mechanical approach. Overall clinical success was 93.3%. Group A showed a significantly lower MID [38.1 (19-122) months] compared with Groups B and C [83.1 (13-168) months; P < 0.0001 vs. 95.4 (12-384) months; P < 0.0001]. Mean implant duration between Groups B and C did not differ significantly (P = 0.28). Clinical and complete procedural success was 100% in Group A. Clinical success rate was higher in Group C than in Group B (97.0 vs. 76.9%, P = 0.018). Complete procedural success did not differ significantly between Groups B and C (88.9 vs. 76.9%; P = 0.132). In Groups B and C, absence of complete procedural success occurred in long implanted leads (MID 107.8 ± 36.4 and 137.6 ± 89.2 months). Relative costs per extracted lead were 49% higher in Group B than in Group C. CONCLUSION: In case of long implanted leads a laser and a mechanical approach are comparable in complete procedural success and safety. Clinical success and cost effectiveness analysis favours the mechanical approach. Regardless of the extraction technique efficacy and safety optimization has to focus on long implanted leads.

Generator pocket adhesions of cardiac leads: classification and correlation with transvenous lead extraction results.

OBJECTIVES: Pacemaker (PM) and implantable cardioverter defibrillator (ICD) leads become encapsulated intravascularly and in the generator pocket by fibrotic adhesions that accumulate over time. These adhesions are responsible for the difficulty and risk of lead extraction procedures. We developed a classification scheme for pocket adhesions, classified all of the patients in the cohort, and examined the relationship between pocket adhesions and the outcome of the procedure. METHODS: The classification of adhesions with respect to the intraoperative adhesion coverage was as followed: class 0 = adhesion free; class 1 ≤ 30% of adhesion coverage; class 2 = 30-60% of adhesion coverage; and class 3 ≥ 60% coverage. Patient data between December 2010 and March 2012 were collected. A total of 100 leads were extracted from 58 patients (1.7 ± 0.8 leads/patient); the mean lead implant duration was 78.5 ± 66.7 months, and the percentage of PM/ICD leads was 68% (n = 68)/32% (n = 32). RESULTS: Distribution of the leads among classes: 0 = 10; 1 = 17; 2 = 25; and 3 = 48. Average implant times (months) according to the adhesion classes: 0 = 1.2 ± 0.4; 1 = 19.8 ± 19.2; 2 = 79.3 ± 46.6; and 3 = 115.1 ± 106.0 (correlation-coefficient 0.71; P ≤ 0.05). Average numbers of extraction tools used according to the adhesions: 0 = none; 1 = 0.4 ± 0.7; 2 = 1.6 ± 1.0; and 3 = 2.3 ± 1.2 (correlation coefficient = 0.67; P ≤ 0.05). Complete removal was achieved in 100% of the patients in classes 0 and 1; 96% in class 2 (n = 24); and 75% in class 3 (n = 36) (P ≤ 0.05). Mortality = 0. CONCLUSIONS: Extensive adhesions in the generator pocket predict the need for a higher number of extraction tools. High-grade pocket adhesions predict lower success rates with regard to complete lead extraction. Both findings suggest that the degree of pocket adhesions predicts the degree of intravascular adhesions.

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.

Off-pump surgery for the poor ventricle?

Severely decreased ejection-fraction is an established risk-factor for worse outcome after cardiac surgery. We compare outcomes of off-pump coronary artery bypass grafting (OPCAB) and on-pump CABG (ONCABG) in patients with severely compromised EF. From 2004 to 2009, 478 patients with a decreased EF ≤35% underwent myocardial-revascularization. Patients received either OPCAB (n = 256) or ONCABG (n = 222). Propensity score (PS), including 50 preoperative risk-factors, was used to balance characteristics between groups. PS adjusted logistic regression analysis was performed to assess mortality and major adverse cardiac and cerebrovascular events (MACCE). A composite endpoint for major non-cardiac complications such as respiratory failure, renal failure, rethoracotomy was applied. Complete revascularization (CR) was assumed when the number of distal anastomoses was larger than that of diseased vessels. There was no difference for mortality (2.3 vs. 4.1%; PS-adjusted odds ratio (PS-OR) = 1.05; p = 0.93) and MACCE (13.7 vs. 17.6%; PS-OR = 1.22; p = 0.50) including myocardial-infarction (1.4 vs. 4.9%; PS-OR = 0.39; p = 0.26), low cardiac output (2.3 vs. 4.7%; PS-OR = 0.75; p = 0.72) and stroke (2.3 vs. 2.7%; PS-OR = 0.69; p = 0.66). OPCAB patients presented with a trend to less frequent occurrence of the non-cardiac composite (12.1 vs. 22.1%; PS-OR = 0.54; p = 0.059) including renal dysfunction (PAOR = 0.77; 95% CI 0.31-1.9; p = 0.57), bleeding (PAOR = 0.42; 95% CI 0.14-1.20; p = 0.10) and respiratory failure (PAOR = 0.39; 95% CI 0.05-3.29; p = 0.39). The rate of complete revascularization was similar (92.2 vs. 92.8%; PS-OR = 0.75; p = 0.50). OPCAB in patients with severely decreased EF is safe and feasible. It may even benefit these patients in regard to non-cardiac complications and does not come at cost of less complete revascularization.

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.

Off-pump surgery is not a contraindication for patients with a severely decreased ejection fraction.

BACKGROUND: A severely impaired left ventricular ejection fraction (EF) (30%) increases the risk of surgical myocardial revascularization. We evaluated the safety and feasibility of off-pump coronary artery bypass (OPCAB) surgery in patients with a severely decreased EF. METHODS: We compared 79 patients with an EF ≤30% (group A) with 863 patients with an EF >30% (group B) who underwent myocardial revascularization between 2003 and 2008. The relationship between EF and outcome after OPCAB was assessed by univariate and logistic regression analyses. A composite end point was constructed from 30-day mortality, renal failure, length of stay in the intensive care unit (ICU) >2 days, neurologic complications, and use of an intra-aortic balloon pump (IABP). Additionally, the completeness of revascularization was assessed. RESULTS: The mortality rates for groups A and B were comparable (1.3% and 2.0%, respectively; P = .55), and the 2 groups did not differ with regard to serious postoperative complications, such as stroke (2.5% versus 1.4% for groups A and B, respectively; P = .42), peripheral neurologic complications (2.5% versus 0.7%, P = .14), renal failure (0% versus 1.1%, P = 1.00), use of an IABP (1.3% versus 0.8%, P = .50), ICU length of stay >2 days (17.7% versus 19.6%, P = .77). Similarly, groups A and B did not differ with regard to ventilation time (11.2 ± 12.7 hours versus 12.4 ± 15.5 hours, P = .82), indicating similar postoperative courses for the 2 groups of patients. In contrast, the composite end point occurred significantly more frequently in group A (43.0% versus 29.7%, P = .02), a result driven by the increased rate of rethoracotomy for bleeding in that group (11.4% versus 2.9%, P = .001). The 2 groups were similar with respect to the total number of grafts used per patient (3.82 ± 0.89 versus 3.63 ± 1.01, P = .10) and the completeness of revascularization (94% versus 93%, P = .49). CONCLUSION: A standardized OPCAB approach is safe for patients with a severely decreased EF, and its use does not come at the cost of less complete revascularization.

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.

Heart team approach in treatment of mitral regurgitation: patient selection and outcome.

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.

Impact of preoperative nesiritide on renal function after mitral valve surgery.

Nesiritide, a recombinant B-type natriuretic peptide used for the intravenous treatment of acute decompensated congestive heart failure. Concerns have been raised about the long-term use of nesiritide, but data is scarce regarding its use in acute congestive heart failure and during cardiac surgery. We conducted a retrospective data review to address the safety of nesiritide for pretreatment of patients undergoing mitral valve surgery.

A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry.

BACKGROUND: Vein graft disease (VGD) impairs graft patency rates and long-term outcomes after coronary artery bypass grafting (CABG). DuraGraft is a novel endothelial-damage inhibitor developed to efficiently protect the structural and functional integrity of the vascular endothelium. The DuraGraft registry will evaluate the long-term clinical outcomes of DuraGraft in patients undergoing CABG procedures. METHODS: This ongoing multicentre, prospective observational registry will enrol 3000 patients undergoing an isolated CABG procedure or a combined procedure (ie, CABG plus valve surgery or other surgery) with at least one saphenous vein grafts or one free arterial graft (ie, radial artery or mammary artery). If a patient is enrolled, all free grafts (SVG and arterial will be treated with DuraGraft. Data on baseline, clinical, and angiographic characteristics as well as procedural and clinical events will be collected. The primary outcome measure is the occurrence of a major adverse cardiac event (MACE; defined as death, non-fatal myocardial-infarction, or need for repeat-revascularisation). Secondary outcome measures are the occurrence of major adverse cardiac and cerebrovascular events (MACCE; defined as death, non-fatal myocardial-infarction, repeat-revascularisation, or stroke), patient-reported quality of life, and health-economic data. Patient assessments will be performed during hospitalisation, at 1-month, 1-year, and annually thereafter to 5 years post-CABG. Events will be adjudicated by an independent clinical events committee. This European, multi-institutional registry will provide detailed insights into clinical outcome associated with DuraGraft. DISCUSSION: This European, multi-institutional registry will provide detailed insights into clinical outcome associated with the use of DuraGraft. Beyond that, and given the comprehensive data sets comprising of patient, procedural, and graft parameters that are being collected, the registry will enable for multiple subgroup analyses targeting focus groups or specific clinical questions. These may include analysis of subpopulations such as patients with diabetes or multimorbid high-risk patients (patient level), evaluation of relevance of harvesting technique including endoscopic versus open conduit harvesting (procedural level), or particular graft-specific aspects (conduit level). TRIAL REGISTRATION: ClinicalTrials.gov NCT02922088 . Registered October 3, 2016. ETHICS AND DISSEMINATION: The regional ethics committees have approved the registry. Results will be submitted for publication.

"AF HeartTeam" Guided Indication for Stand-alone Thoracoscopic Left Atrial Ablation and Left Atrial Appendage Closure.

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 endoscopic surgery early in the series. There were no deaths. Procedure duration was a median of 124min (Range 83-211) and duration of hospitalization was median of 5 days (Range 3-12). During 36 months follow-up survival free of mortality, thromboembolic events or strokes was 100%. Twelve month freedom from atrial arrhythmia off anti-arrhythmic medication was 93% and 89% for paroxysmal and non-paroxysmal patients respectively. 6/42 patients who had an AF recurrence during the follow-up underwent touch-up catheter ablation. CONCLUSIONS: Atrial fibrillation heart team approach provides excellent outcomes for patients with AF. This approach is beneficial for patients after failed catheter ablation or not candidates for such and offers a very effective mid-term outcome data. In addition to effective rhythm control the protective effect of epicardial LAA closure may play an important role in effectively reducing stroke. The creation of an AF HeartTeam as recommended by the guidelines insures unbiased therapies and provides access to this minimally invasive but effective therapeutic option for AF patients.

Closure of Large Percutaneous Femoral Venous Access Using a Modified "Figure-of-Eight" Suture.

Recent advances in different percutaneous treatments made insertion of large-caliber sheaths in the femoral veins more common. Venous punctures are historically managed by initial manual compression with subsequent application of a compression bandage and bed rest. We describe a modified "figure-of-eight" suture technique for minimizing the risk of accidental puncture of the vein while grabbing the subcutaneous tissue. We examined the safety and feasibility of this technique combined with early mobilization in a real-world setting. We performed a retrospective analysis on 56 consecutive patients undergoing percutaneous mitral valve repair using large femoral venous access. The patient population was heterogeneous and bleeding risk characteristics were common. Bleeding Academic Research Consortium Consensus (BARC)-classifiable bleeding complications occurred in eight patients (14%), BARC of two events or more in five patients (8.9%), and BARC of three or more event in only one patient (1.8%), which is a comparable success rate to large venous access closure with suture-mediated closure devices. No BARC Type 3b or BARC Type 5 bleeding occurred. During routine clinical follow-up, no groin-related problems were reported in all patients. Closure of large femoral venous access using a modified temporary subcutaneous figure-of-eight suture in combination of a light compression bandage and bed rest for 2 to 4 hours provides a safe and low-cost alternative to closure devices for early mobilization.

Increased neointimal formation after surgical vein grafting in a murine model of type 2 diabetes.

BACKGROUND: Diabetes is an independent risk factor for the development of neointimal hyperplasia and subsequent vein graft failure after coronary or peripheral artery bypass grafting. We evaluate a new mouse model of surgical vein grafting to investigate the mechanisms of neointimal formation in the setting of type 2 diabetes. METHODS AND RESULTS: Surgical vein grafts were created by inserting vein segments from age-matched C57BL/KsJ wild-type mice into the infra-renal aorta of lepr(db/db) diabetic and C57BL/KsJ wild-type mice. Mice were euthanized &4 weeks later, and vein grafts were analyzed using morphometric and immunohistochemical techniques. A significant increase in neointimal formation was noted in lepr(db/db) mice (139+/-64 versus 109+/-62 mm2; P=0.008) after 4 weeks. This difference was mainly secondary to an increase in collagen formation within the lesion in the vein grafts from lepr(db/db) mice (0.53+/-0.4 versus 0.44+/-0.05; P<0.001), whereas only slight increases (P=not significant) in alpha actin-stained smooth muscle cells were noted in the lepr(db/db) mice. CONCLUSIONS: We established a new physiologically relevant model of surgical vein grafting in mice. In this report, type 2 diabetes was associated with significant increase in extracellular matrix deposition in addition to increased smooth muscle cell deposition. This new model may allow mechanistic studies of cellular and molecular pathways of increased neointimal formation in the setting of diabetes.