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.

Predictors of Physical Capacity 6 Months After Implantation of a Full Magnetically Levitated Left Ventricular Assist Device: An Analysis From the ELEVATE Registry.

BACKGROUND: In patients with a continuous-flow left ventricular assist device, preimplant predictors of poor physical performance are not well-described. We aimed to identify predictors of inability to walk more than 300 m on 6-minute walk test (6MWT) 6 months after HeartMate 3 implantation. METHODS AND RESULTS: Using data from the European Registry of Patients Implanted With a Full Magnetically Levitated LVAD, patients with available 6MWT at 6 months after implantation were included (N = 194) and grouped according to 6MWT distance (6MWD) of >300 m (n = 150) or 6MWD of <300 m (n = 44). Patients walking <300 m were older (60 ± 10 vs 52 ± 12 years; P < .001), more often New York Heart Association functional class IV (63% vs 42%; P = .03), and more often had type 2 diabetes (43% vs 17%; P < .001) at implantation. Atrial fibrillation was seen in 57% in those with a 6MWT of <300 m vs 31% in those walking longer (P < .002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking <300 m (both P < .01). In multivariable regression analysis, independent predictors of a 6MWD of <300 m were: atrial fibrillation (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.12-8.67), older age (OR for 10-year increment, 2.81; 95% CI, 1.55-5.07), New York Heart Association functional class IV (OR, 3.37; 95% CI, 1.27-8.98), and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (OR, 6.53; 95% CI, 1.92-22.19). CONCLUSIONS: Six months after HeartMate 3 implantation, 77% of patients walked >300 meters in 6 minutes. Apart from age and measures of heart failure severity, atrial fibrillation at implantation is an independent predictor of low 6MWD at 6 months after implantation.

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.

Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial.

BACKGROUND AND PURPOSE: The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG. METHODS: Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days. RESULTS: From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, -3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes. CONCLUSIONS: Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing. CLINICAL TRIAL REGISTRATION: URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906.

Influence of experience on procedure steps, safety, and functional results in edge to edge mitral valve repair-a single center study.

OBJECTIVES: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. BACKGROUND: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). METHODS: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. RESULTS: The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip® implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups. CONCLUSION: Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.

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.

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.).

Hemodynamic Improvement at Three Months after MitraClip® Treatment in End-Stage Heart Failure Patients with Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR. METHODS: A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization. RESULTS: The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p <0.001) and cardiac output (+0.5 l/min, p <0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8). CONCLUSIONS: Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

German Heart Report 2013.

OBJECTIVES: The 25th German Heart Report provides a comprehensive analysis of morbidity and mortality in patients with selected heart diseases as well as services and care in cardiology and cardiac surgery in Germany during the period 2011-2012. It is the result of a multidisciplinary collaboration between the German Heart Foundation, the German Cardiac Society, the German Society for Thoracic and Cardiovascular Surgery, and the German Society of Pediatric Cardiology and is based on data from different sources. In addition, trends of the period from 1995 to 2012 are presented. RESULTS: The trends in morbidity due to cardiac diseases in 2010 and previous years continued in 2011. Compared with data from 1995 to 2010, one can observe: · a slight decrease in ischemic heart disease in every age group.. · a distinct increase in valve diseases, predominantly at age >75 years.. · an increase in arrhythmias from the age of 45 years on.. · an increase in cardiac failure, especially beyond the age of 75 years.. Compared with data from 2009, the mortality rates in 2011 differ somewhat; there is: · a decrease in heart failure and coronary heart disease.. · no change in arrhythmias.. · a distinct increase in valvular heart diseases.. · an additional, small decrease in congenital heart defects.. These data are in agreement with findings from other Western countries. Coronary heart disease, the most frequent cardiac disease, has continuously decreased in frequency and mortality since 2000. The underlying reasons are discussed. CONCLUSION: This report is an important resource for all parties of the healthcare system regarding heart disease conditions and their treatment in Germany.

[Commentary by the German Society for Thoracic and Cardiovascular Surgery on the positions statement by the German Cardiology Society on quality criteria for transcatheter aortic valve implantation (TAVI)]. / Kommentar der Deutschen Gesellschaft für Thorax-, Herz- und Gefäßchirurgie zum Positionspapier der DGK - Qualitätskriterien zur Durchführung der transvaskulären Aortenklappenimplantation (TAVI).

Surgical aortic valve replacement is still considered the first-line treatment for patients suffering from severe aortic valve stenosis. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as an alternative for selected high-risk patients. According to the latest results of the German external quality assurance program, mandatory by law, the initially very high mortality and procedural morbidity have now decreased to approximately 6 and 12%, respectively. Especially in Germany, the number of patients treated by TAVI has increased exponentially. In 2013, a total of 10.602 TAVI procedures were performed. TAVI is claimed to be minimally invasive. This is true concerning the access, but it does not describe the genuine complexity of the procedure, defined by the close neighborhood of the aortic valve to delicate intracardiac structures. Hence, significant numbers of life-threatening complications may occur and have been reported. Owing to the complexity of TAVI, there is a unanimous concordance between cardiologists and cardiac surgeons in the Western world demanding a close heart team approach for patient selection, intervention, handling of complications, and pre- as well as postprocedural care, respectively. The prerequisite is that TAVI should not be performed in centers with no cardiac surgery on site. This is emphasized in all international joint guidelines and expert consensus statements. Today, a small number of patients undergo TAVI procedures in German hospitals without a department of cardiac surgery on site. To be noted, most of these hospitals perform less than 20 cases per year. Recently, the German Cardiac Society (DGK) published a position paper supporting this practice pattern. Contrary to this statement and concerned about the safety of patients treated this way, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) still fully endorses the European (ESC/EACTS) and other actual international guidelines and consensus statements. Only the concomitance of departments for cardiac surgery and cardiology on site can provide optimal TAVI care. This commentary by the DGTHG delineates the data and resources upon which its opinion is based.

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.

Stroke and thrombus formation appending to the MitraClip: what is the appropriate anticoagulation regimen?

Percutaneous mitral valve repair with the MitraClip system (Abbot Vascular, USA) is a promising technique for the non-surgical treatment of mitral regurgitation in special situations. The case is reported of a 72-year-old patient with history of atrial fibrillation and a severely impaired left ventricular function who underwent successful MitraClip implantation because of functional mitral regurgitation grade 3. The patient's post-interventional course was complicated three weeks later by a cardioembolic stroke due to thrombus formation on the MitraClip, despite receiving dual platelet therapy.

Long-term outcomes after aortic root repair using selective sinus replacement.

OBJECTIVES: The study aim was to evaluate long-term results after anatomic restoration of the aortic root. METHODS: During an 18-year period, a total of 669 patients underwent valve-sparing root repair (aneurysm 554, dissection 115) using selective sinus replacement. None/trivial, mild, moderate, and severe (grades 3+ and 4+) insufficiency were present in 57, 146, 204, and 262 patients, respectively. RESULTS: The anatomic repair was adjusted to the existing aortic annulus diameter, which was 27.0 ± 3.0 mm on average. Replacement of 1, 2, or 3 sinuses of Valsalva was performed in 209, 234, and 226 patients, respectively. Altogether, 454 additional procedures on the cusps were performed, mostly as cusp patch plasty with pericardium (210). Thirty-day mortality was 0.6%. The mean follow-up duration was 7.1 ± 4.1 years (range, 0.01-19.1 years). The estimated freedom from relevant aortic insufficiency grade 3+ or greater (15 events) was 98% ± 1%, 97% ± 1%, and 94% ± 3% at 5, 10, and 15 years, respectively. On echocardiogram, no patient revealed a considerable change of the form or size of the repaired root, which was confirmed radiologically in 160 patients who received computed tomography angiography for any reason. Multivariate logistic regression analysis identified cusp prolapse/pseudo-prolapse as the only independent risk factor for the development of recurrent insufficiency grade 2+ or greater (41 occurrences), with a hazard ratio of 3.258 (95% confidence interval, 1.658-6.403; P = .001). An association between aortic annulus size and functional results could not be demonstrated. CONCLUSIONS: Patient-tailored root repair using isolated sinus replacement offers excellent functional long-term results regardless of underlying root pathology or annulus size. Aortic cusp pathology was decisive for long-term valve function.