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Objectives: We investigated the sex-related difference in characteristics and 2-year outcomes after surgical aortic valve replacement (SAVR) by propensity-score matching (PSM)., Methods: Data from 2 prospective registries, the INSPIRIS RESILIA Durability Registry (INDURE) and IMPACT, were merged, resulting in a total of 933 patients: 735 males and 253 females undergoing first-time SAVR. The PSM was performed to assess the impact of sex on the SAVR outcomes, yielding 433 males and 243 females with comparable baseline characteristics., Results: Females had a lower body mass index (median 27.1 vs 28.0 kg/m2; P = 0.008), fewer bicuspid valves (52% vs 59%; P = 0.036), higher EuroSCORE II (mean 2.3 vs 1.8%; P < 0.001) and Society of Thoracic Surgeons score (mean 1.6 vs 0.9%; P < 0.001), were more often in New York Heart Association functional class III/IV (47% vs 30%; P < 0.001) and angina Canadian Cardiovascular Society III/IV (8.2% vs 4.4%; P < 0.001), but had a lower rate of myocardial infarction (1.9% vs 5.2%; P = 0.028) compared to males. These differences vanished after PSM, except for the EuroSCORE II and Society of Thoracic Surgeons scores, which were still significantly higher in females. Furthermore, females required smaller valves (median diameter 23.0 vs 25.0 mm, P < 0.001). There were no differences in the length of hospital stay (median 8 days) or intensive care unit stay (median 24 vs 25 hours) between the 2 sexes. At 2 years, post-SAVR outcomes were comparable between males and females, even after PSM., Conclusions: Despite females presenting with a significantly higher surgical risk profile, 2-year outcomes following SAVR were comparable between males and females., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background and Aims: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries., Methods: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety., Results: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%)., Conclusions: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention., Methods: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed., Results: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2., Conclusions: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement., Clinical Trial Registration: clinicaltrials.gov: NCT03666741., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, requiring lifelong anticoagulation or interventional, transseptal left atrial appendage (LAA) occluder implantation to minimize stroke risk. Incomplete LAA closure post implantation is a frequent observation. Incomplete LAA occlusion after transseptal occluder implantation necessitates anticoagulation in cases of persistent AF to minimze risk of embolism and/or apoplexy. Patients with contraindications to lifelong anticoagulation therapy are challenging to treat and alternative options are needed. We present a case of a patient with persistent AF who underwent frustraneous LAA occluder implantation. The patient's anatomy necessitated surgical closure of the LAA, which was accomplished with an LAA clip 4 weeks after implantation. The patient was discharged in excellent clinical status 5 days after the surgery. No further complications were observed within the following year., (Published by Oxford University Press and JSCR Publishing Ltd. All rights reserved. © The Author(s) 2020.)

Minimally invasive cardiac surgery (MICS) via right lateral mini thoracotomy is the gold standard treatment approach for mitral and tricuspid valve disorders. Other selected procedures (e.g. transapical aortic valve implantation, MIDCAB) require a left lateral mini thoracotomy for surgical access. Advantages of MICS over complete sternotomy are well known, but access-related complications post MICS, such as pulmonary herniation, are often underestimated/overlooked. In males, a pulmonary herniation in the proximity of the former thoracotomy is often clinically visible, especially when the intrathoracic pressure rises (e.g. during coughing). In females, clinical symptoms may be hidden by the breast and patients often have unspecific complaints or occasional pain when coughing, making identification of a lung herniation more difficult. Chest computed tomography is the diagnostic tool of choice for pulmonary herniations. Using a series of 20 patients with pulmonary herniation post MICS, we report our findings in diagnosis and treatment of this condition., (Published by Oxford University Press and JSCR Publishing Ltd. All rights reserved. © The Author(s) 2020.)

Aims: Preserved vascular function represents a key prognostic factor in type 2 diabetes mellitus (T2DM), but data on vascular parameters in this patient cohort are scarce. Patients with T2DM often need more than one drug to achieve optimal glucose control. The aim of this study was to analyse the efficacy of two combination therapies on vascular function in subjects with T2DM., Methods and Results: This prospective, randomized study included 97 subjects with T2DM. Subjects were randomized to either the combination therapy empagliflozin (E) 10 mg with linagliptin (L) 5 mg once daily or metformin (M) 850 or 1000 mg twice daily with insulin glargine (I) once daily. At baseline and after 12 weeks, subjects had peripheral office and 24-h ambulatory blood pressure (BP) measurement and underwent vascular assessment by pulse wave analysis under office and ambulatory conditions. Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I. There were greater decreases in 24-h ambulatory peripheral systolic (between-group difference: -5.2 ± 1.5 mmHg, P = 0.004), diastolic BP (-1.9 ± 1.0 mmHg, P = 0.036), and PP (-3.3 ± 1.0 mmHg, P = 0.007) in E + L than M + I. Central office systolic BP (-5.56 ± 1.9 mmHg, P = 0.009), forward pressure height of the pulse wave (-2.0 ± 0.9 mmHg, P = 0.028), 24-h ambulatory central systolic (-3.6 ± 1.4 mmHg, P = 0.045), diastolic BP (-1.95 ± 1.1 mmHg, P = 0.041), and 24-h pulse wave velocity (-0.14 ± 0.05m/s, P = 0.043) were reduced to a greater extent with E + L., Conclusion: Beyond the effects on glycaemic control, the combination therapy of E + L significantly improved central BP and vascular function compared with the classic combination of M + I., Clinicaltrials.gov: NCT02752113., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Left atrial appendage (LAA) closure with the WATCHMAN device is an alternative to anticoagulation therapy for the prevention of stroke in selected patients with atrial fibrillation (AF). Infrequently, left atrial (LA) device-related thrombus formation occurs and it is poorly understood. Thrombus formation due to incomplete covering of the LAA is even rarer and may occur within the first few months after device implantation., Case Summary: Here, we present a case of a 68-year-old male patient with permanent AF, drug- and hepatitis induced liver cirrhosis (CILD Score B), and prior aortic valve replacement. The patient had a history of percutaneous LAA closure using a WATCHMAN device. He developed massive peri-device leak and thrombus arising from the space between the device and appendage cleft 2 years after implantation. Because of the high bleeding risk with a HAS-BLED score of 5 points, surgery was chosen as the therapy of choice instead of long-term anticoagulation. The patient was discharged in good clinical condition and has been scheduled for a yearly follow-up., Discussion: This case emphasizes the importance of choosing appropriately sized LAA occluder devices and planning for regular post-interventional follow-ups to minimize the risk of per-device leaks and thrombi., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: The presence of a stiff guidewire in the apex of the left ventricle (LV) is a known risk factor for LV perforation. Our goal was to minimize the risk of LV rupture during transcatheter aortic valve implantation (TAVI) by omitting the interaction between the stiff guidewire and the LV apex using a modified procedure., Methods: A TAVI protocol designed to allow minimal interaction between a stiff guidewire and the LV was developed in Linköping University Hospital in Sweden. A total of 316 patients were treated exclusively by this approach between March 2014 and May 2018., Results: All procedures were completed successfully. There were no cases (0%) of ventricular perforation. Only 1 patient (0.3%) had a pericardial effusion, and it was due to annulus rupture. There was 1 case of acute kidney injury (0.3%). Five patients (1.6%) required a new permanent pacemaker. Stroke occurred in 3 patients (0.9%). No patient had valve embolization. Vascular complications were experienced by 6 patients (1.9%). A mild paravalvular leak occurred in 27 (8.5%) patients. At 30 days post-TAVI, 6 patients (2%) had died. The mortality rate at 1 year was 8.6% (n = 20/232)., Conclusions: Our series shows that TAVI without the prolonged use of a stiff guidewire in the LV apex is feasible. The risk of LV perforation is eliminated by this approach, and other procedural complications are limited., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI., Methods: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization., Results: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75)., Conclusions: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring., Clinical Trial Registration Number: ClinicalTrials.gov identifier: NCT01991431., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

We report on a 61-year-old man with a previously unknown interruption of the inferior vena cava who was scheduled to undergo minimally invasive mitral and tricuspid valve surgery. We aimed to establish a cardiopulmonary bypass using femorofemoral cannulation under transoesophageal echocardiography. In spite of multiple attempts, the positioning of the venous wire in the right atrium was not accomplished. The intervention was subsequently performed by an open sternotomy. Further to the intervention, the patient underwent thoraco-abdominal multislice computed tomography that excluded the presence of an abdominal tumour or vena cava thrombosis but revealed atresia of the inferior vena cava.

Objectives: This study sought to assess the incremental prognostic value of the psoas muscle area in patients scheduled for transcatheter aortic valve implantation (TAVI)., Methods: A total of 1076 consecutive patients undergoing TAVI at 2 centres between 2010 and 2017 were prospectively included in this study. Computed tomography-derived cross-sectional area of the psoas muscle was measured at the superior border of the third (L3) and fourth (L4) lumbar vertebra and indexed to body surface area (PMAi) as well as stratified into tertiles. Multivariable logistic regression and Cox regression analyses were performed to investigate the value of PMAi as a predictor of 30-day and cumulative mortality. The incremental prognostic value of PMAi over the Society of Thoracic Surgeons (STS) score was assessed using a net reclassification analysis., Results: The rate of 30-day mortality was 5.8% (n = 62). PMAi at the level of L3 [odds ratio 0.082, 95% confidence interval (CI) 0.011-0.589; P = 0.013] and L4 (odds ratio 0.049, 95% CI 0.005-0.536; P = 0.013) was independently associated with 30-day mortality. During a median follow-up of 435 days (interquartile range 139-904), 292 patients (27.1%) died. PMAi of L3 (hazard ratio 0.200, 95% CI 0.083-0.482; P < 0.001) and L4 (hazard ratio 0.083, 95% CI 0.029-0.235; P < 0.001) was independently associated with mortality during follow-up. The addition of PMAi to the STS score led to a net reclassification improvement for 30-day and cumulative mortality., Conclusions: PMAi emerged as a valuable outcome predictor in patients undergoing TAVI. The addition of PMAi to the established STS score led to an increase in its prognostic ability.

Background Transcatheter aortic valve implantation (TAVI) continues to gain popularity in the management of patients with severe aortic stenosis (SAS). Distribution of resources to maximise appropriate use remains a priority. Design & methods To determine the current perceptions and behaviours regarding SAS patient management, an 18-point multiple-choice questionnaire was distributed to European Society of Cardiology (ESC) Council for Cardiology Practice (CCP) e-journal and/or electronic newsletter subscribers. Respondents to all questions were considered. Sub-analyses based on respondent age, practice setting and geographical location were performed. Results Of 1245 full respondents, 41.5% were aged ≥ 51 years, 22.7% were aged 41-50 years and 35.8% were aged ≤ 40 years. The majority were located in Europe (77.5%), followed by Asia/Oceania (11.6%), America (7.6%) and Africa (3.4%). In-hospital and out-of-hospital cardiologists accounted for 57.4% of and 28.5% of the sample, respectively, with the remainder being general practitioners/other. The majority of respondents (70.1%) claimed to diagnose between one and five cases of SAS per month. Free access to TAVI was reported by 41.2%, being less common for those aged ≤ 40 years (32.7%; p < 0.001), those located in Asia/Oceania, America and Africa (20.1%, 18.1% and 2.4%, respectively; p < 0.01 in each case) and in-hospital compared to out-of-hospital cardiologists (35.7% vs. 54.5%, respectively; p < 0.001). The most common reason for not referring a patient for an aortic valve intervention was assessment that the patient was high risk/non-operable (55.5%), followed by short life expectancy (30.5%). The most common reason for referring a patient for TAVI over surgical replacement was surgical risk score (56.9%). The most commonly perceived main complication of TAVI was stroke (28.9%), while the most frequently selected main benefit was improvement in quality of life (37.2%). A high proportion (82.5%) of respondents believed that TAVI is/may become a viable option for lower-risk SAS patients in future. Conclusion The population of potential TAVI is significant worldwide, with key barriers to referral being access limitations and poor physician education. Strategies to minimise these factors are paramount.

Objectives: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates., Methods: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI., Results: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment., Conclusions: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Objectives: It may be expected that patients with left ventricular dysfunction may be at greater risk of complications after transcatheter aortic valve implantation (TAVI) via transapical (TA) access compared with via transfemoral (TF) access. There is a lack of data comparing the outcomes of TAVI using TA and TF access in patients with a reduced left ventricular ejection fraction (EF)., Methods: This is a retrospective analysis of data from a high-volume heart centre in Germany. TAVI access route assignment was based on a 'best for TF' approach, where only patients who met a strict set of criteria underwent TF-TAVI, with the remainder receiving TA-TAVI. For this analysis, patients were included if they had a pre-TAVI EF of ≤ 40%. Early mortality and late (1-year) mortality were compared through multivariate logistic regression., Results: A total of 342 patients in the registry had an EF of ≤ 40%, of which 74.9% underwent TA-TAVI and 25.1% underwent TF-TAVI. Higher proportions of the TA group presented with certain comorbidities, and their logistic EuroSCORE and Society of Thoracic Surgeons (STS) risk scores were higher than in the TF group. At 1 year, TA access was associated with greater mortality in the univariate analysis (odd ratio 2.43; 95% confidence interval 1.04-5.69). However, after multivariate adjustment, no significant differences were found in either 30-day or 1-year mortality rates., Conclusions: The data suggest that, for patients with a reduced EF, TA-TAVI is not associated with a poorer outcome compared with TF-TAVI. Therefore, TA access should not be discounted based on the presence of left ventricular dysfunction alone., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information., Methods: ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed., Results: Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group., Conclusions: Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis., Clinicaltrials.gov Identifier: NCT01991431., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice., Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points., Results: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P  = 0.46 and 1% vs. 3%, P  = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P  = 0.76), rates of stroke 2% vs. 0% ( P  = 0.24), pacemaker implantation (11% vs. 4%, P  = 0.093), and life-threatening bleeding 4% vs. 3% ( P  = 0.70). Valve safety (both 85%, P  = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups., Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation., Clinicaltrials.gov: NCT01991431., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background Despite a wide range of medications being available for the prevention of cardiovascular events such as stroke, myocardial infarction and mortality in both a primary and secondary setting, patient adherence to complex therapy regimens involving different drug classes remains low worldwide. Combining antiplatelet, antihypertensive, lipid-lowering and potentially further drugs into one 'polypill' has the potential to increase adherence, thereby reducing risk factors to a greater extent and for a longer duration. The World Health Organization has recently highlighted increased adherence as a key development need for reducing cardiovascular disease. Methods Recent clinical trial data regarding adherence, reductions in cardiovascular risk and outcomes, safety and tolerability and the cost-effectiveness of the polypill approach are summarised and reviewed. In addition, ongoing trials and the questions they intend to answer are considered. References were retrieved from a PubMed literature search (date range 1990-2016) using the terms 'polypill', 'cardiovascular events' and 'adherence', and selected based on relevance. The website www.clinicaltrials.gov was also consulted for the identification of ongoing trials. Conclusions To date, the polypill approach has been conclusively shown to increase adherence relative to usual care in all patients, with those in a primary care setting or with poor baseline adherence potentially standing to benefit most. Concomitant risk factor reductions have also been suggested. However, whether this translates into a reduction in cardiovascular events and generates good cost-effectiveness in a given healthcare environment is currently under further investigation.

Objectives: To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access., Methods: A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed., Results: Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21-8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates., Conclusions: The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: Atrial fibrillation (AF) is a common condition that is a major cause of stroke. A significant proportion of patients with AF are not classically symptomatic at diagnosis or soon after diagnosis. There is little information comparing their characteristics, treatment, and outcomes of patients with symptoms, which predominate in clinical trials to those without., Methods and Results: We analysed data from the Prevention of Thromboembolic Events-European Registry in Atrial Fibrillation. This was a prospective, real-world registry with a 12-month follow-up that included AF patients aged 18 years and over. Patients were divided into those with and without AF symptoms using the European Heart Rhythm Association (EHRA) score (Category I vs. Categories II-IV). Of the 6196 patients (mean age 72 years) with EHRA scores available, 501 (8.1%) were asymptomatic. A lower proportion of asymptomatic patients was female (22.8 vs. 41.2%), with less noted to have heart failure and coronary artery disease (P < 0.01 for all). There were no differences in terms of the prevalence of diabetes, obesity, or prior stroke. Asymptomatic patients had a lower CHA2DS2-VASc score (2.9 ± 1.7 vs. 3.4 ± 1.8; P < 0.01) and HAS-BLED score (1.8 ± 1.1 vs. 2.1 ± 1.2; P < 0.01). During the 1-year follow-up, adverse events occurred at similar frequencies in asymptomatic and symptomatic patients (1.6 vs. 0.8% for ischaemic stroke; P = 0.061; 1.4 vs. 1.3% for transient ischaemic attack; P = 0.840). Patients with higher CHA2DS2-VASc and HAS-BLED scores experienced more events, independent of symptoms. Antithrombotic therapy was comparable for both groups at baseline and at follow-up., Conclusions: The similar clinical characteristics and frequency of adverse events between asymptomatic and symptomatic AF patients revives the question of whether screening programmes to detect people with asymptomatic AF are worthwhile, particularly in those aged 65 and over potentially likely to have clinical and economic benefits from anticoagulants. This evidence may be informative if clinicians may not be comfortable participating in future clinical trials, leaving asymptomatic patients with AF and high stroke risk without anticoagulation.

Aims: Microalbuminuria (MAU) is a marker for endothelial dysfunction and a predictor of increased cardiovascular risk. Physical activity improves endothelial function. This analysis aims to explore the impact of regular physical exercise on the prevalence and the degree of MAU in hypertensive individuals at high cardiovascular risk., Methods and Results: The International Survey Evaluating microAlbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) studied the prevalence of MAU in 20,786 hypertensive patients at high cardiovascular risk. Herein, we investigated the relationship between self-reported physical activity and MAU in relation to the number of cardiovascular risk factors, medication and co-morbidities. A total of 7123 patients (34.3%) performed regular physical exercise (moderate or strenuous, at least 4 hours per week). The prevalence of MAU was significantly lower in active than in inactive patients (54% vs 61%; P < 0.0001). This association was observed in all classes of blood pressure and heart rate and was similar in patients with and without diabetes mellitus. Urinary albumin excretion (UAE) was lower in active than in inactive patients (UAE 80 mg/l: 11.6% vs 13.5%, P < 0.0001; UAE 150 mg/l: 7.5% vs 10%; P < 0.0001). In a multivariate analysis adjusted for age, gender, blood pressure, heart rate, renal function, medication and comorbidities, regular physical activity was associated with a 25% lower risk for MAU (odds ratio (OR) 0.75; 95% confidence interval (CI), 0.67-0.84; P < 0.0001). Risk reduction for MAU was more pronounced in strenuously active (OR 0.66; 95%CI, 0.47-0.95; P < 0.05) than in moderately active patients (OR 0.76; 95%CI, 0.68-0.85; P < 0.0001)., Conclusion: In hypertensive patients at high cardiovascular risk, physical activity is an independent predictor for a decreased risk of microalbuminuria.

Background: Patients with type-2 diabetes are at risk for treatment- and disease-related complications. Little is known about the interrelation of hypoglycaemia and co-morbid vascular disease (VD), defined as coronary heart disease, stroke and peripheral arterial disease., Hypothesis: Hypoglycaemia is associated with co-morbid VD in diabetic patients., Methods: DiaRegis is a prospective registry that included patients with type-2 diabetes in 2009/2010. Metric variables are displayed as median and quartiles. For the comparison of patients with or without VD Odds Ratios (OR) were determined from univariate analyses and adjusted for differences in patient characteristics (multivariable analysis)., Results: Data on hypoglycaemia and VD within the last 12 months were available for 3741 patients (98.2%) with a median (IQR) age of 65.9 (57.6-72.9) years; 46.7% were female. VD patients (n = 909; 24.3%) were older (70.7 vs 63.9 years; p < 0.0001), less often female (33.6% vs 50.9%; p < 0.0001) and had had diabetes for a longer duration (6.4 vs 5.4 years; p < 0.0001). Mean cholesterol (total, HDL and LDL) was also slightly lower (p < 0.0001). Glycaemic control (HbA1c, fasting and postprandial glucose) was comparable. VD patients received less metformin (80.7 vs 85.2%; p < 0.01) and more sulfonylureas (31.8 vs 27.6%; p < 0.05). There was an increased incidence of symptomatic hypoglycaemia with or without requiring help and with a need for medical assistance. After adjusting a number of baseline variables the rates of symptomatic hypoglycaemias with help remained significantly increased (OR 3.73 (95% CI 1.31-10.65) in patients with VD., Conclusions: As hypothesized there is a strong association between the incidence of hypoglycaemia and vascular disease at comparable glycaemic control, which confirms prior randomized controlled trial data suggesting an interrelationship between hypoglycaemia and vascular disease.

Aims: To investigate the relationship between microalbuminuria (MAU) and atrial fibrillation (AF) and to further evaluate whether the heart rate dependency of MAU in patients without AF is maintained in patients with a history of AF., Methods and Results: The International Survey Evaluating Microalbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) included 18,900 patients without and 1705 patients with a history of AF suffering from hypertension and other risk factors for cardiovascular disease in 26 countries worldwide from September 2005 to March 2006. Heart rate, blood pressure, urinary albumin excretion, and an estimated glomerular filtration rate were determined among other parameters. The prevalence of MAU was higher at higher heart rate in both patients with and without a history of AF. Prevalence of MAU was about 10% higher in patients with a history of AF (P < 0.001). Male gender, the presence of diabetes mellitus, a higher heart rate, and a higher diastolic blood pressure were independently associated with increased odds for MAU in patients without and with a history of AF., Conclusion: The prevalence of MAU in hypertensive patients with cardiovascular risk factors is related to heart rate and significantly higher in patients with a history of AF.

Aims: Patients with paroxysmal atrial fibrillation (AF) often present with typical angina pectoris and mildly elevated levels of cardiac troponin (non ST-segment elevation myocardial infarction) during an arrhythmic event. However, in a large proportion of these patients, significant coronary artery disease is excluded by coronary angiography. Here we explored the potential underlying mechanism of these events., Methods and Results: A total of 14 pigs were studied using a closed chest, rapid atrial pacing (RAP) model. In five pigs RAP was performed for 7 h (600 b.p.m.; n = 5), in five animals RAP was performed in the presence of angiotensin-II type-1-receptor (AT(1)-receptor) inhibitor irbesartan (RAP+Irb), and four pigs were instrumented without intervention (Sham). One-factor analysis of variance was performed to assess differences between and within the three groups. Simultaneous measurements of fractional flow reserve (FFR) and coronary flow reserve (CFR) before, during, and after RAP demonstrated unchanged FFR (P = 0.327), but decreased CFR during RAP (RAP: 67.7 +/- 7.2%, sham: 97.2 +/- 2.8%, RAP+Irb: 93.2 +/- 3.3; P = 0.0013) indicating abnormal left ventricular (LV) microcirculation. Alterations in microcirculatory blood flow were accompanied by elevated ventricular expression of NADPH oxidase subunit Nox2 (P = 0.039), lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1, P = 0.004), and F(2)-isoprostane levels (P = 0.008) suggesting RAP-related oxidative stress. Plasma concentrations of cardiac troponin-I (cTn-I) increased in RAP (RAP: 613.3 +/- 125.8 pmol/L vs. sham: 82.5 +/- 12.5 pmol/L; P = 0.013), whereas protein levels of eNOS and LV function remained unchanged. RAP+Irb prevented the increase of Nox2, LOX-1, and F(2)-isoprostanes, and abolished the impairment of microvascular blood flow., Conclusion: Rapid atrial pacing induces AT(1)-receptor-mediated oxidative stress in LV myocardium that is accompanied by impaired microvascular blood flow and cTn-I release. These findings provide a plausible mechanism for the frequently observed cTn-I elevation accompanied with typical angina pectoris symptoms in patients with paroxysmal AF and normal (non-stenotic) coronary arteries.

Background: Although the relationship between body weight and blood pressure (BP) is well established, there is a lack of data regarding the impact of obesity on the prevalence of hypertension in primary care practice. The objective of this study was to assess the prevalence of hypertension and the diagnosis, treatment status, and control rates of hypertension in obese patients as compared to patients with normal weight., Methods: A cross-sectional point prevalence study of 45,125 unselected consecutive primary care attendees was conducted in a representative nationwide sample of 1912 primary care physicians in Germany (HYDRA)., Results: Blood pressure levels were consistently higher in obese patients. Overall prevalence of hypertension (blood pressure >/=140/90 mm Hg or on antihypertensive medication) in normal weight patients was 34.3%, in overweight participants 60.6%, in grade 1 obesity 72.9%, in grade 2 obesity 77.1%, and in grade 3 obesity 74.1%. The odds ratio (OR) for good BP control (<140/90 mm Hg) in diagnosed and treated patients was 0.8 (95% confidence interval [CI] 0.7-0.9) in overweight patients, 0.6 (95% CI 0.6-0.7) in grade 1, 0.5 (95% CI 0.4-0.6) in grade 2, and 0.7 (95% CI 0.5-0.9) in grade 3 obese patients., Conclusions: The increasing prevalence of hypertension in obese patients and the low control rates in overweight and obese patients document the challenge that hypertension control in obese patients imposes on the primary care physician. These results highlight the need for specific evidence-based guidelines for the pharmacologic management of obesity-related hypertension in primary practice.