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1.
Article in English | MEDLINE | ID: mdl-38218725

ABSTRACT

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.

2.
Case Rep Oncol ; 16(1): 1500-1507, 2023.
Article in English | MEDLINE | ID: mdl-38033416

ABSTRACT

Introduction: Salivary duct carcinoma (SDC) is an aggressive and rare subtype of salivary gland carcinoma. Surgical excision and radiotherapy are standard of care for early cancer. Chemotherapies with taxanes and platinum show overall response rates between 39% and 50%. SDCs are often associated with an overexpression of the androgen receptor (AR) and HER2/neu which have recently become druggable targets. Case Presentation: Here, we report on an 84-year-old male patient with metastatic SDC of the right parotid gland. In 2017, he underwent a right total parotidectomy, a right neck dissection, and an infratemporal fossa clearance followed by 6 weeks of radiotherapy. In 2018, due to metastatic spread in the lungs, bones, and pararenal gland, a pathological workup of the tumor tissue was performed and revealed both AR and HER2 overexpression, respectively. Consequently, he underwent androgen deprivation therapy and, due to asymptomatic progression, sequentially human epidermal growth factor receptor 2 (HER-2)-targeted therapy with ado-trastuzumab emtansine and neratinib, which led to stable disease during the course of about 18 months. The electronically captured patient-reported outcome had demonstrated a good tolerance of all three therapeutic lines. Conclusion: In conclusion, since effective standard therapeutic treatment options for SDC may often not be tolerable in older patients, the implementation of personalized and adaptive treatments, especially in patients with rare tumor types, might offer valuable treatment options.

3.
Int J Surg ; 109(4): 707-715, 2023 Apr 01.
Article in English | MEDLINE | ID: mdl-36912566

ABSTRACT

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.


Subject(s)
Coronary Artery Disease , Myocardial Infarction , Stroke , Humans , Male , Middle Aged , Aged , Female , Quality of Life , Prospective Studies , Stroke Volume , Treatment Outcome , Ventricular Function, Left , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Stroke/etiology
4.
Eur J Cardiothorac Surg ; 62(4)2022 09 02.
Article in English | MEDLINE | ID: mdl-35929787

ABSTRACT

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.


Subject(s)
Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , Stroke , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Coronary Artery Disease/complications , Humans , Myocardial Infarction/complications , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/methods , Registries , Stroke/epidemiology , Stroke/etiology , Treatment Outcome
5.
Open Heart ; 7(2)2020 07.
Article in English | MEDLINE | ID: mdl-32690553

ABSTRACT

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.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Patient Care Team , Aged , Aged, 80 and over , Clinical Decision-Making , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/mortality , Hemodynamics , Hospital Mortality , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Annuloplasty/adverse effects , Mitral Valve Annuloplasty/instrumentation , Mitral Valve Annuloplasty/mortality , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Patient Readmission , Patient Selection , Prosthesis Design , Recovery of Function , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome
6.
J Cardiothorac Surg ; 15(1): 56, 2020 Apr 03.
Article in English | MEDLINE | ID: mdl-32245388

ABSTRACT

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.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/instrumentation , Animals , Atrial Fibrillation/complications , Disease Models, Animal , Dogs , Feasibility Studies , Female , Male , Pericardium/surgery , Surgical Stapling/instrumentation , Treatment Outcome
7.
J Cardiothorac Surg ; 14(1): 174, 2019 Oct 15.
Article in English | MEDLINE | ID: mdl-31615560

ABSTRACT

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.


Subject(s)
Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Mammary Arteries/transplantation , Organ Preservation Solutions/therapeutic use , Radial Artery/transplantation , Saphenous Vein/transplantation , Vascular Patency , Aged , Endoscopy , Endothelium, Vascular , Female , Humans , Longitudinal Studies , Male , Middle Aged , Mortality , Myocardial Infarction/epidemiology , Prospective Studies , Quality of Life , Registries , Reoperation/statistics & numerical data , Stroke/epidemiology , Treatment Outcome
8.
J Atr Fibrillation ; 11(5): 2039, 2019.
Article in English | MEDLINE | ID: mdl-31139293

ABSTRACT

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.

9.
J Am Coll Cardiol ; 72(12): 1346-1353, 2018 09 18.
Article in English | MEDLINE | ID: mdl-30213326

ABSTRACT

BACKGROUND: Percutaneous left atrial appendage exclusion (LAAE) has evolved as an alternative strategy for stroke prevention in atrial fibrillation (AF). Recent observational data have suggested that epicardial LAAE can have substantial impact on arrhythmia burden and hemodynamic profile. OBJECTIVES: The authors aimed to study the impact of epicardial versus endocardial LAAE on systemic blood pressure in hypertensive AF patients. METHODS: This was a prospective, nonrandomized study comparing 247 patients who underwent epicardial LAAE with 124 patients with endocardial exclusion. Clinical outcomes were measured at 3 months and 1 year. Primary outcome was improvement in systolic blood pressure (SBP) between both groups compared with baseline. Secondary outcome included changes in diastolic pressures (DBP), serum electrolytes, and creatinine. RESULTS: There was no significant difference in baseline SBP between epicardial and endocardial groups. SBP was significantly lower in the epicardial group both at 3 months (122 ± 11.8 mm Hg vs. 129.7 ± 8.2 mm Hg; p < 0.001) and 1 year (123 ± 11.6 mm Hg vs. 132.2 ± 8.8 mm Hg; p < 0.001) compared with the endocardial group. An adjusted multivariate linear mixed effects model demonstrated that epicardial LAAE significantly decreased SBP by 7.4 mm Hg at 3 months and by 8.9 mm Hg at 1 year (p < 0.0001). There was a trend toward lower DBP with epicardial LAAE at 3 months by 1.3 mm Hg (p = 0.2) and at 1 year by 1.8 mm Hg (p = 0.09). There was no significant difference in serum electrolytes and creatinine between both groups. CONCLUSIONS: In hypertensive AF patients, epicardial LAAE significantly decreases SBP both at 3 and 12 months compared with endocardial exclusion.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/therapy , Hypertension/therapy , Aged , Cardiac Surgical Procedures/instrumentation , Creatinine/blood , Female , Humans , Magnesium/blood , Male , Potassium/blood , Prospective Studies , Sodium/blood , Stroke/prevention & control , Systole
10.
Innovations (Phila) ; 13(2): 147-151, 2018.
Article in English | MEDLINE | ID: mdl-29688942

ABSTRACT

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.


Subject(s)
Femoral Vein/surgery , Mitral Valve/surgery , Perioperative Period/adverse effects , Punctures/adverse effects , Suture Techniques/economics , Sutures/economics , Adult , Aged , Aged, 80 and over , Bed Rest/economics , Compression Bandages/economics , Female , Hemodynamics/physiology , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Perioperative Period/statistics & numerical data , Punctures/statistics & numerical data , Retrospective Studies , Risk Factors , Suture Techniques/standards , Sutures/standards , Treatment Outcome , Vascular Closure Devices/standards
12.
Eur Heart J Cardiovasc Imaging ; 19(1): 23-30, 2018 01 01.
Article in English | MEDLINE | ID: mdl-28065915

ABSTRACT

Aims: The Edwards Sapien 3 heart valve prosthesis (S3) is commonly used for transcatheter aortic valve implantation (TAVI) and is available in three sizes. To date no data has been published on the effective orifice area (EOA) and the hemodynamic performance of the three different S3 sizes. The aim of this study was to measure the size-specific EOA and hemodynamic performance of the S3 in short-term and 1-year follow-up. Methods and results: One hundred and thirteen consecutive patients treated by TAVI with a S3 prosthesis at the Heart Clinic Zurich between May 2014 and July 2015 were included. Clinical data were extracted from the Swiss TAVI registry. The EOA was calculated using Doppler echocardiography (peri-interventionally and at discharge) and by 3D-biplane transoesophageal echocardiography (peri-interventionally). Mean transvalvular gradients (dPmean) were additionally calculated with Doppler echocardiography at 30 days and 1 year. Results were analysed separately for the 23 mm (n = 42; 37%), 26 mm (n = 46; 41%), and 29 mm (n = 25; 22%) prostheses. At discharge, the EOAs were 1.6 ± 0.2 cm2 (23 mm S3), 2.0 ± 0.2 cm2 (26 mm S3), and 2.7 ± 0.2 cm2 (29 mm S3), p < 0.001. The dPmeans at discharge were 10.9 ± 6.0 mmHg (23 mm S3), 10.4 ± 3.5 mmHg (26 mm S3), and 8.9 ± 2.8 mmHg (29 mm S3), p = 0.235, and did not significantly change over time within any of the S3 sizes. Conclusions: Post-TAVI, the EOAs of the three different S3 prosthesis sizes differ significantly, the transvalvular gradients, however, are comparable. Mean transvalvular gradients remain stable over time and document good prosthesis function after 1 year.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/anatomy & histology , Heart Valve Prosthesis , Hemodynamics/physiology , Transcatheter Aortic Valve Replacement/methods , Analysis of Variance , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnostic imaging , Cohort Studies , Echocardiography/methods , Echocardiography, Transesophageal/methods , Female , Follow-Up Studies , Humans , Linear Models , Male , Prosthesis Design , Registries , Retrospective Studies , Severity of Illness Index , Switzerland , Tertiary Care Centers , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
14.
Europace ; 20(7): e105-e114, 2018 07 01.
Article in English | MEDLINE | ID: mdl-29016813

ABSTRACT

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.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/instrumentation , Coronary Artery Bypass , Coronary Artery Disease/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation , Pericardium/surgery , Stroke/prevention & control , Adult , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Atrial Fibrillation/physiopathology , Cardiac Surgical Procedures/adverse effects , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Female , Heart Valve Diseases/diagnosis , Heart Valve Diseases/mortality , Heart Valve Prosthesis Implantation/adverse effects , Humans , Incidence , Male , Middle Aged , Pericardium/physiopathology , Prospective Studies , Registries , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
15.
Herzschrittmacherther Elektrophysiol ; 28(4): 360-365, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29150698

ABSTRACT

The increasing prevalence of atrial fibrillation with the aging population and its associated major morbidity and mortality due to thromboembolic stroke have resulted in intensive research on stroke prevention or stroke risk reduction strategies. Several surgical techniques for left atrial appendage (LAA) occlusion have evolved over the past decades. Surgeons have been using different techniques leading to highly variable and, in particular, poor data on outcomes. LAA closure is performed either as a concomitant procedure during open-heart surgery or as a stand-alone surgical procedure as part of minimally invasive (mini-thoracotomy or thoracoscopy) arrhythmia surgery. Data on the safety and feasibility of surgical LAA occlusion are derived mainly from nonrandomized case series, observational and cohort studies, or registries with mostly inconclusive and conflicting results. Increased awareness of the high failure rates in attaining complete LAA occlusion, thus avoiding poor surgical techniques (e. g., simple suture ligation, endocardial suturing etc.), and the availability of newer devices (e. g., AtriClip device) have recently led to improved surgical results in the literature. If further validated in large-scale studies, these recent promising developments in the field of surgical LAA treatment seem to offer alternatives for patients ineligible for oral anticoagulation therapy with vitamin K antagonists or newer non-vitamin-K-dependent oral anticoagulants.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Thromboembolism , Anticoagulants , Humans
16.
Nat Rev Cardiol ; 14(12): 727-743, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28795688

ABSTRACT

With a steadily increasing prevalence, atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and an independent risk factor for stroke caused by thromboembolic events. The left atrial appendage (LAA) is the primary source of thromboemboli in patients with nonvalvular AF who have a stroke. Novel strategies (such as mechanical and nonpharmacological intervention) targeting the LAA in patients with AF for stroke prevention have become a major focus during the past decade. Some devices for percutaneous LAA occlusion are supported by robust clinical data obtained from randomized trials or large registries, and are a valid alternative to pharmacological stroke prevention. However, the incidence of periprocedural complications and the presence of device-related thrombi or residual LAA leaks, whose long-term clinical implications are still unknown, are limiting factors in wider acceptability of these techniques. In this Review, we discuss the available techniques for LAA occlusion in patients with nonvalvular AF at high risk of stroke. We describe the pharmacological and mechanical approaches to LAA occlusion, and provide the current clinical evidence for various strategies. We particularly focus on the current management of the LAA, and discuss the challenges and future implications of the available approaches to LAA occlusion.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/methods , Registries , Thromboembolism/prevention & control , Atrial Fibrillation/complications , Humans , Risk Factors , Thromboembolism/etiology
17.
J Atr Fibrillation ; 10(4): 1655, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29487681

ABSTRACT

Left atrial appendage closure was originally described by Madden in 1949 who was the first to perform appendix amputation. This was a very invasive procedure with poor outcome, but preformed for stroke prevention. Much later, it was James Cox whom described the Cox-Maze procedure, which included multiple incisions to create a maze like pathway for the electrical impulse to go undisturbed from the sinus node down to the atrio-ventricular node. Since then cardiac surgeons stopped focusing on the left atrial appendage and went on about seemingly more important things. Only with the advent of catheter based options for stand alone left atrial appendage closure did the interest in the field light up again.

19.
Vascular ; 24(5): 523-30, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26767606

ABSTRACT

AIM: To describe the long-term experience of a simplified frozen elephant trunk technique (sFETT) used in complicated acute type A aortic dissection (AAAD) treatment. METHODS AND RESULTS: Between January 2001 and December 2012, 34 patients (mean age 59.9 ± 11.0 years) with complicated AAAD (DeBakey I) underwent an emergency surgery including sFETT. sFETT consisted in gluing the dissected aortic arch wall layers with gelatine-resorcinol adhesive and video-assisted antegrade open arch aortic stent-graft deployment in the arch or proximal descending aorta. In addition to sFETT, the aortic root was addressed with standard techniques. A 30-day mortality was 14.7% (five patients) due to bleeding (1), multiple organ failure (2), and colon ischemia (2). Postoperative morbidity included neurological (2), renal (1) and cardio-pulmonary complications (4), as well as wound infection (1). Mean follow-up was 74.4 ± 45.0 months. Actual survival rates were 73.5% at 1 year, 70.2% at 5 years, and 58.5% at 13 years of follow-up. Six patients died during long-term follow-up from heart failure (1) and unknown reasons (5). Five patients required reoperation for aortic arch (3) or aorto-iliac (2) progression of aneurysm during the mid- and long-term follow-up. The remaining patients showed favorable evolution of the dissected aorta with false lumen occlusion in most cases and stable aortic diameters. CONCLUSIONS: In AAAD patients, sFETT as used in our series is an easy and safe technique to repair the aortic arch. Long-term results after sFETT showed false lumen occlusion and stable aortic diameter in up to 13 years of follow-up.


Subject(s)
Aortic Aneurysm/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Acute Disease , Adult , Aged , Aged, 80 and over , Aortic Dissection/diagnostic imaging , Aortic Dissection/mortality , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/mortality , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Computed Tomography Angiography , Emergencies , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/surgery , Prosthesis Design , Reoperation , Retrospective Studies , Risk Factors , Stents , Time Factors , Tissue Adhesives/therapeutic use , Treatment Outcome , Video-Assisted Surgery
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