Oral Anticoagulation Use and Left Atrial Appendage Occlusion in LAAOS III.

BACKGROUND: LAAOS III (Left Atrial Appendage Occlusion Study III) showed that left atrial appendage (LAA) occlusion reduces the risk of ischemic stroke or systemic embolism in patients with atrial fibrillation undergoing cardiac surgery. This article examines the effect of LAA occlusion on stroke reduction according to variation in the use of oral anticoagulant (OAC) therapy. METHODS: Information regarding OAC use was collected at every follow-up visit. Adjusted proportional hazards modeling, including using landmarks of hospital discharge, 1 and 2 years after randomization, evaluated the effect of LAA occlusion on the risk of ischemic stroke or systemic embolism, according to OAC use. Adjusted proportional hazard modeling, with OAC use as a time-dependent covariate, was also performed to assess the effect of LAA occlusion, according to OAC use throughout the study. RESULTS: At hospital discharge, 3027 patients (63.5%) were receiving a vitamin K antagonist, and 879 (18.5%) were receiving a non-vitamin K antagonist oral anticoagulant (direct OAC), with no difference in OAC use between treatment arms. There were 2887 (60.5%) patients who received OACs at all follow-up visits, 1401 (29.4%) who received OAC at some visits, and 472 (9.9%) who never received OACs. The effect of LAA occlusion on the risk of ischemic stroke or systemic embolism was consistent after discharge across all 3 groups: hazard ratios of 0.70 (95% CI, 0.51-0.96), 0.63 (95% CI, 0.43-0.94), and 0.76 (95% CI, 0.32-1.79), respectively. An adjusted proportional hazards model with OAC use as a time-dependent covariate showed that the reduction in stroke or systemic embolism with LAA occlusion was similar whether patients were receiving OACs or not. CONCLUSIONS: The benefit of LAA occlusion was consistent whether patients were receiving OACs or not. LAA occlusion provides thromboembolism reduction in patients independent of OAC use.

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.

BACKGROUND: Surgical occlusion of the left atrial appendage has been hypothesized to prevent ischemic stroke in patients with atrial fibrillation, but this has not been proved. The procedure can be performed during cardiac surgery undertaken for other reasons. METHODS: We conducted a multicenter, randomized trial involving participants with atrial fibrillation and a CHA2DS2-VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating greater risk of stroke) who were scheduled to undergo cardiac surgery for another indication. The participants were randomly assigned to undergo or not undergo occlusion of the left atrial appendage during surgery; all the participants were expected to receive usual care, including oral anticoagulation, during follow-up. The primary outcome was the occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism. The participants, research personnel, and primary care physicians (other than the surgeons) were unaware of the trial-group assignments. RESULTS: The primary analysis population included 2379 participants in the occlusion group and 2391 in the no-occlusion group, with a mean age of 71 years and a mean CHA2DS2-VASc score of 4.2. The participants were followed for a mean of 3.8 years. A total of 92.1% of the participants received the assigned procedure, and at 3 years, 76.8% of the participants continued to receive oral anticoagulation. Stroke or systemic embolism occurred in 114 participants (4.8%) in the occlusion group and in 168 (7.0%) in the no-occlusion group (hazard ratio, 0.67; 95% confidence interval, 0.53 to 0.85; P = 0.001). The incidence of perioperative bleeding, heart failure, or death did not differ significantly between the trial groups. CONCLUSIONS: Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it. (Funded by the Canadian Institutes of Health Research and others; LAAOS III ClinicalTrials.gov number, NCT01561651.).

Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Sex differences in outcomes after coronary artery bypass grafting: a pooled analysis of individual patient data.

AIMS: Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men. METHODS AND RESULTS: The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04-1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94-1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11-1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04-1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90-1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes. CONCLUSIONS: Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

BACKGROUND: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. METHODS: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. RESULTS: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89-1.19; P=0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89-1.18; P=0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: P=0.02) after off-pump CABG and 72% (95% CI, 67-76) versus 77% (95% CI, 74-80) after on-pump CABG (log-rank test: P=0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01-1.39; P=0.04). CONCLUSIONS: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

Sex-related differences in outcomes after coronary artery bypass surgery-A patient-level pooled analysis of randomized controlled trials: rationale and study protocol.

INTRODUCTION: The impact of sex on the outcomes after coronary artery bypass grafting (CABG) is controversial. The majority of CABG studies are retrospectively collected clinical or registry data, women comprise only a minority, and the reported findings represent the male predominated cohort. This individual patient meta-analysis is aimed at evaluating sex-related differences in outcomes after CABG using high quality data from randomized controlled trials (RCTs). METHODS AND ANALYSIS: A systematic literature search will be performed to identify all CABG RCTs (minimum follow-up: 5 years). Detailed specification for the minimum deidentified patient records' data requirements will be provided to RCT primary contact to request their deidentified data for pooling. The pooled analysis will follow the prospective register of systematic reviews (PROSPERO) and the preferred reporting items for systematic reviews and meta-analyses for individual patient data systematic reviews (PRISMA-IPD) recommendations and will compare sex-related outcomes after CABG. The main hypothesis is that outcomes after CABG are worse in women than in men. We will also test whether treatment effects for off-pump and the use of multiple arterial grafts are present within each sex, and also, whether there are differential treatment effects between sexes. The primary endpoint will be a composite of all-cause mortality, myocardial infarction, stroke, and repeat revascularization at long-term follow up. ETHICS AND DISSEMINATION: Ethics approval and participant consent for the study will be obtained locally by each study team if needed. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. METHODS: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. RESULTS: There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5-1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46-1.60]; clampless device: 1.8%; OR 0.67 [0.26-1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37-2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64-1.20]). CONCLUSION: Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.

Left ventricular ejection fraction of < 20%: Too bad for MitraClip© ?

OBJECTIVES: This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance. BACKROUND: The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function. MATERIALS AND METHODS: Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up. RESULTS: In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760). CONCLUSION: By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.

Impact of right and left ventricular systolic dysfunction on perioperative outcome and long-term survival after transcatheter aortic valve replacement.

BACKGROUND: Aim of the study was to determine the impact of right- and left-ventricular systolic dysfunction on perioperative outcome and long-term survival after TAVR. METHODS: Study population consisted of 702 TAVRs between 2009 and 2014, 345 by TF, 357 by TA route. RV and LV function were determined by TAPSE and LVEF measurement during baseline echocardiography. Patients were divided according to TAPSE (>18 mm/14-18 mm/<14 mm) and LVEF (>50%/30-50%/<30%) tertiles. Outcome at day-30 and Kaplan-Meier 4-year survival were analyzed. RESULTS: Impaired RV and LV-function did not adversely affect mortality, stroke, bleeding, and vascular-complications at 30 days. Patients with TAPSE < 14 mm displayed elevated rate of renal failure requiring dialysis (11%; P < 0.01). Kaplan-Meier survival was adversely affected by RV-systolic dysfunction RVSD (P < 0.01). Multivariate analysis revealed that impaired RVSD but not LVSD was an independent determinant for late mortality (hazard ratio TAPSE 14-18 mm: 1.53; P = 0.02; TAPSE <14 mm: 2.12; P < 0.01). CONCLUSIONS: Peri-operative mortality and risk of stroke after TAVR are not adversely affected by preexisting RV or LV dysfunction. Long-term survival is impaired in patients with RVSD. RVSD but not LVSD is an independent risk factor for late mortality. TAVR should be the preferred therapy for patients with RVSD and LVSD, especially when patient is suitable for TF.

Incidence and Clinical Impact of Cerebral Lesions after the MitraClip® Procedure.

BACKGROUND: Clinically silent brain injury detected with cerebral magnetic resonance imaging (MRI) is well known after various cardiovascular interventions. Thus far, only one study has examined the periprocedural risk of cerebral ischemic events in patients undergoing percutaneous mitral valve reconstruction. The study aim was to examine the incidence and clinical impact of cerebral embolic events in patients undergoing percutaneous mitral valve reconstruction using the MitraClip® system. METHODS: Thirteen eligible high-risk patients without contraindications for MRI underwent MitraClip treatment at the authors' institution. Neurological testing with the assessment of global cognitive function was performed three days before and two days after the procedure. All patients underwent cerebral diffusion-weighted MRI (DWI) two days after the procedure. RESULTS: In nine patients, post-interventional MRI revealed newly acquired microembolic cerebral lesions. At follow up MRI scans recorded at 307 ± 270 days after the procedure, ischemic scars were not detectable in any patient. Two patients with five or more new cerebral lesions in DW-MRI showed a significant decline in their test scores. CONCLUSIONS: The MitraClip procedure results in acute cerebral lesions in the vast majority of patients. All lesions seen on DWI post-procedure resolved completely, but the number of lesions may have had an impact on cognitive function.

Off-pump versus on-pump coronary-artery bypass grafting in elderly patients.

BACKGROUND: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined. METHODS: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery. RESULTS: A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P=0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P=0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P=0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment. CONCLUSIONS: In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667.).

Emergency cardiac surgery during transfemoral and transapical transcatheter aortic valve implantation: incidence, reasons, management, and outcome of 411 patients from a single center.

OBJECTIVES AND BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly performed in high-risk patients with severe aortic valve stenosis. Incidence and impact of emergency cardiac surgery (ECS) during TAVI is unclear. METHODS AND RESULTS: Two-hundred twenty one transapical (TA) and 190 transfemoral (TF) TAVIs were performed at our hospital between 01/2009 and 12/2012. Twenty patients (4.9%) required ECS, more frequently in the TF- (n = 11; 5.8%) than in the TA-group (n = 9; 4.1%; P = 0.017). ECS-cases were evenly distributed throughout the 4 years. Baseline characteristics of the ECS-patients were not different from the non-ECS-patients. Reasons were acute cardiac failure, coronary obstruction, annular rupture, valve migration, right- and left-ventricular perforation, severe paravalvular leakage, aortic dissection, and mitral valve damage. Surgical intervention consisted of peripheral CPB, switch to TA, thoracotomy and suture of perforated cardiac chambers and conventional aortic valve replacement with concomitant repair of associated cardiovascular injury. Thirty-day mortality was 35.0%, and 55.0% could be salvaged to hospital discharge. Kaplan-Meier 1-year survival curves were significantly impaired for patients requiring ECS (TF: P < 0.0001, HR 8.716; TA: P = 0.013, HR 2.813). CONCLUSIONS: Life-threatening complications requiring bail-out ECS occur in a substantial proportion during TAVI. ECS dramatically affects early and late outcome after TAVI. Under optimal conditions more than half of the ECS-patients can be salvaged. With the current technology of THV-systems ECS should be an integral part of the logistic conditions surrounding TAVI and is far from being futile in this patient population.

Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation.

OBJECTIVES: Aim of this study was to analyze feasibility, efficacy, and safety of a double-ProGlide preclose technique for access site closure after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: An effective and safe transcutaneous closure device is advantageous in transfemoral TAVI to avoid surgical cut down of the large caliber sheath insertion site. The use of two ProGlide sutures has not been described in this context in a large patient cohort. METHODS: ProGlide closure was used between 2010 and 2012 in 162 patients. ProGlide sutures were deployed in a preclose technique prior to insertion of the large caliber sheath. Success of the closure technique was defined as effective hemostasis and no further access site-related vascular or bleeding complications during the index hospitalization. RESULTS: Patients were 82 ± 5 years old with a logistic EuroSCORE of 16.7 ± 12.5. Edwards SAPIEN valves were used in 81.5% and Medtronic CoreValves in 18.5%. The overall success rate of the double-ProGlide technique was 93.9%. Success rate was only 40.0% under circumstances of prolonged high-dose heparinization. Success rate was 96.8% among the patients on dual-antiplatelet therapy (DAPT). All 10 ProGlide failures could effectively be managed by either percutaneous angioplasty or surgical reconstruction. The rate of VARC major vascular complications was 4.3%. Thirty-day mortality was 5.6%. CONCLUSION: The double-ProGlide preclose technique offers a simple, highly effective, and safe method for closure of the arterial access site after transfemoral TAVI. The double-ProGlide strategy results in low rates of major vascular complications and translates into favorable early outcome.

Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

Cost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III Trial.

Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no-occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no-occlusion group, a mean difference of -$612 (95% CI, -$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of -$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery.

Radial artery versus saphenous vein versus right internal thoracic artery for coronary artery bypass grafting.

OBJECTIVES: We used individual patient data from 4 of the largest contemporary coronary bypass surgery trials to evaluate differences in long-term outcomes when radial artery (RA), right internal thoracic artery (RITA) or saphenous vein graft (SVG) are used to complement the left internal thoracic artery-to-left anterior descending graft. METHODS: Primary outcome was all-cause mortality. Secondary outcome was a composite of major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction and stroke). Propensity score matching and Cox regression were used to reduce the effect of treatment selection bias and confounders. RESULTS: A total of 10 256 patients (1510 RITA; 1385 RA; 7361 SVG) were included. The matched population consisted of 1776 propensity score-matched triplets. The mean follow-up was 7.9 ± 0.1, 7.8 ± 0.1 and 7.8 ± 0.1 years in the RITA, RA and SVG cohorts respectively. All-cause mortality was significantly lower in the RA versus the SVG [hazard ratio (HR) 0.62, 95% confidence interval (CI): 0.51-0.76, P = 0.003] and the RITA group (HR 0.59, 95% CI 0.48-0.71, P = 0.001). Major adverse cardiac and cerebrovascular event rate was also lower in the RA group versus the SVG (HR 0.78, 95% CI 0.67-0.90, P = 0.04) and the RITA group (HR 0.75, 95% CI 0.65-0.86, P = 0.02). Results were consistent in the Cox-adjusted analysis and solid to hidden confounders. CONCLUSIONS: In this pooled analysis of 4 large coronary bypass surgery trials, the use of the RA was associated with better clinical outcomes when compared to SVG and RITA.

Thrombocytopenia after aortic valve replacement with the Sorin Freedom Solo prosthesis.

BACKGROUND AND AIM OF THE STUDY: Thrombocytopenia after implantation of the Sorin Freedom Solo (FS) stentless aortic bioprosthesis has been described previously. Thus, relevant data acquired at the authors' institution were analyzed. METHODS: A comparison of platelet counts was made in patients operated on between January and August 2008 following implantation of either the FS valve (n = 26) or a stented pericardial prosthesis (n = 238). Thrombocyte levels were measured before surgery and on days 0, 1, 2, 3, 5 and 7 after surgery; a comparison was made using absolute and hematocrit-adjusted platelet counts. Clinical adverse events were investigated in both groups, and a multivariate analysis was performed to identify predictors for the occurrence of thrombocytopenia. RESULTS: After implantation of the FS valve, the mean absolute and hematocrit-adjusted platelet counts were significantly lower on days 2, 3, 5 and 7 after surgery. An additional decrease occurred between days 1 and 3 after surgery, but this was not associated with any adverse clinical outcome. Independent determinants for thrombocytopenia were age and the type of aortic prosthesis. Postoperative echocardiography revealed lower gradients after FS valve implantation. CONCLUSION: Given the superior hemodynamic performance of the FS valve, and the absence of any adverse effects, implantation with this valve may be justified in selected patients. Further clarification of the mechanisms causing thrombocytopenia is required.

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort.

BACKGROUND: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. METHODS: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. RESULTS: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239-2018 pg/ml FMR, 3418-2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21-17 mmHg FMR, 19-13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). CONCLUSIONS: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.