New Insights into Mortality-Related Risk Factors in Infective Endocarditis: Results from the Brandenburg State Endocarditis Register.

OBJECTIVE: Endocarditis as a potentially life-threatening disease with high complication and mortality rates. In recent years, an increase in the incident of endocarditis has been reported throughout Europe. In the aging society, successful treatment is complex and challenging owing to the high rate of multimorbidity. METHODS: We initiated a statewide prospective multicenter endocarditis registry in 2020. Perioperative risk factors, comorbidities, microbiological, laboratory and imaging diagnostics, complications, and mortality including 1-year follow-up were collected. The present midterm analysis includes factors influencing mortality in the first 313 patients. RESULT: In-hospital mortality and 1-year mortality were 28.4 and 40.9%, respectively. Preoperative risk factors include age (p < 0.001), EuroSCORE II (p < 0.001), coronary artery disease (p = 0.022), pacemaker probe infection (p = 0.033), preoperative left ventricular ejection fraction (LVEF), systemic inflammatory response syndrome (SIRS), pulmonary edema, heart failure, septic emboli, acute renal failure, impaired coagulation, hypalbuminemia (p < 0.001), and N-terminal prohormone of brain natriuretic peptide (NTproBNP) (p = 0.001). The presence of peri-annular abscess, perforation, and shunt were associated with increased mortality (p = 0.004, 0.001, and 0.004, respectively). In addition, cardiopulmonary bypass time influenced mortality (p = 0.002). The main postoperative causes of death were multi-organ failure, renal failure, vasoplegia, and low-output syndrome (p < 0.001). Previous endocarditis was 7.7%, while 35.5% were prosthetic valve recipients and 33.6% were redo surgeries. CONCLUSION: Our first registry data show the complexity of endocarditis patients and the challenging treatment. Some risk factors can be treated preoperatively. For instance, hypalbuminemia and the duration of the procedure can be controlled with adequate albumin substitution and carefully planned procedures restricted to the essential requirements, that is, hybrid approaches with consecutive interventions.

Partial versus Complete Sternotomy for Aortic Valve Replacement-Multicenter Study.

BACKGROUND: The benefits of minimally invasive techniques in cardiac surgery remain poorly defined. We evaluated the short- and mid-term outcomes after surgical aortic valve replacement through partial upper versus complete median sternotomy (MS) in a large, German multicenter cohort. METHODS: A total of 2,929 patients underwent isolated surgical aortic valve replacement via partial upper sternotomy (PUS, n = 1,764) or MS (n = 1,165) at nine participating heart centers between 2016 and 2020. After propensity-score matching, 1,990 patients were eligible for analysis. The primary end point was major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction, and stroke at 30 days and in follow-up, up to 5 years. Secondary end points were acute kidney injury, length of hospital stay, transfusions, deep sternal wound infection, Dressler's syndrome, rehospitalization, and conversion to sternotomy. RESULTS: Unadjusted MACCE rates were significantly lower in the PUS group both at 30 days (p = 0.02) and in 5-year follow-up (p = 0.01). However, after propensity-score matching, differences between the groups were no more statistically significant: MACCE rates were 3.9% (PUS) versus 5.4% (MS, p = 0.14) at 30 days, and 9.9 versus 11.3% in 5-year follow-up (p = 0.36). In the minimally invasive group, length of intensive care unit (ICU) stay was shorter (p = 0.03), Dressler's syndrome occurred less frequently (p = 0.006), and the rate of rehospitalization was reduced significantly (p < 0.001). There were 3.8% conversions to full sternotomy. CONCLUSION: In a large, German multicenter cohort, MACCE rates were comparable in surgical aortic valve replacement through partial upper and complete sternotomies. Shorter ICU stay and lower rates of Dressler's syndrome and rehospitalization were in favor of the partial sternotomy group.

Severe structural deterioration of small aortic bioprostheses treated with valve-in-valve transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to evaluate outcomes of valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with degenerated small bioprostheses. METHODS: Outcomes of consecutive 27 high-risk patients (logistic EuroSCORE 35.5 ± 18.5%) with a mean age of 81.0 ± 5.9 years who underwent VIV-TAVI for degenerated small bioprostheses (19 mm-11.1%; 20 mm-11.1%; 21 mm-77.8%) were analyzed. Medtronic CoreValve (n = 11) or CoreValve Evolut-R prostheses (n = 16) were implanted. Follow-up was 3.2 ± 2.0 years. RESULTS: Early mortality was 11.1%. One patient died intraoperatively due to left ventricle perforation, two others during the in-hospital period as a result of sudden cardiac death and pulmonary embolism. VIV-TAVI was completed in 26 cases (96.3%-success rate). Two patients required pacemaker implantation. Acute kidney injury occurred in two other patients. At discharge, mean transvalvular gradient was 19.2 ± 9.5 mmHg and in 25.9% of patients mean gradient exceeded 20 mmHg. Overall mortality was 25.9% and mortality from cardiac or unknown causes at 18.5%. Ninety percent of survivors were in New York Heart Association (NYHA) class I or II. CONCLUSIONS: Transfemoral VIV-TAVI in patients with small, degenerated bioprostheses appears to be a promising alternative to surgery. Although the vast majority of patients have significant improvement in their NYHA class, the rate of persistent, residual gradients is relatively high and will need to be followed closely with serial echocardiograms.

Follow-up on ECMO after Cardiac Surgery: How Can We Evaluate Therapy?

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides temporary cardiorespiratory support for patients in cardiogenic shock despite high-dose inotropic therapy and use of an intra-aortic balloon pump (IABP) [Muehrcke 1996]. Postcardiotomy cardiogenic shock has an incidence of 2%-6% after routine adult cardiac surgery [Hernandez 2007]. There are 0.5%-1.5% of patients who are refractory to medical and device therapy, and cardiogenic shock can lead to multiorgan dysfunction and mortality [Rastan 2010]. Prolonged cardiorespiratory support, which can be achieved with ECMO, may provide time for myocardial recovery and prevent multiorgan dysfunction and reduce mortality [Smedira 2001]. However, this device is associated with serious complications [Khorsandi 2017]. The reported survival rate on ECMO is 36% [Biancari 2018]. The aim of this study is to follow up on factors that can influence therapy outcome for patients who receive VA-ECMO after cardiac surgery.

Does Age Influence the Preoperative Condition and, Thus, the Outcome in Endocarditis Patients?

Background: Demographic changes have led to an increase in the proportion of older patients undergoing heart surgery. The number of endocarditis cases is also steadily increasing. Given the sharp increase in patients who have received valve prostheses or electrophysiological implants, who are on chronic dialysis or taking immunosuppressants, the interdependence of these two developments is quite obvious. We have studied the situation of older patients suffering from endocarditis compared to younger ones. Are they more susceptible, and are there differences in outcomes? Patients and Methods: A total of 162 patients was studied from our database, enrolled from 2020 to 2022. Fifty-four of them were older than 75 years of age (mean age 79.9 ± 3.8 years). The remaining 108 patients had a mean age of 61.6 ± 10.1 years. EuroSCORE II (ES II) was higher in the older patients (19.3 ± 19.7) than in the younger ones (13.2 ± 16.84). The BMI was almost identical. The preoperative NYHA proportions did not differ. A statistical analysis was performed using R. Results: Older patients had a lower left ventricular ejection fraction (LVEF), a higher proportion of coronary heart disease (CHD), a higher amount of N-terminal probrain natriuretic peptides (NT-proBNPs), worse coagulation function, worse renal function than younger patients, and were more often valve prosthesis carriers compared to the younger patients. The diagnostic interval was 66.85 ± 49.53 days in the younger cohort, whereas it was only 50.98 ± 30.55 in the elderly (p = 0.081). Significantly fewer septic emboli were observed in the older patients than in the younger patients, but postoperative delirium and critical illness polyneuropathy and critical illness myopathy (CIP/CIM) were observed significantly more frequently compared to younger patients. In-hospital mortality was higher in older patients than in younger patients, but did not reach statistical significance (29.91% vs. 40.38%; p = 0.256). The postoperative clinical status was worse in older patients than in the younger ones (NYHA-stage, p = 0.022). Conclusions: Age did have an impact on the outcome, probably due to causing a higher number of cumulative preoperative risk factors. However, an interesting phenomenon was that older patients had fewer septic emboli than younger patients. It can only be speculated whether this was due to a shorter diagnostic interval or lower mobility, i.e., physical exertion. Older patients suffered more frequently than younger ones from typical age-related postoperative complications, such as delirium and CIP/CIM. In-hospital mortality was high, but not significantly higher compared to the younger patients. Considering the acceptable mortality risks, and in light of the lack of alternatives, older patients should not be denied surgery. However, individual consideration is necessary.

VARC-3 defined outcome of valve-in-valve transcatheter aortic valve implantation in stentless compared with stented aortic bioprostheses.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable alternative to redo surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in stented bioprosthetic valves (ST); stentless bioprostheses (SL) lack fluoroscopic markers and could be more challenging for ViV-TAVI. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce. We compared patient characteristics, procedural outcomes, and 5-year mortality of patients with SL versus ST aortic bioprosthetic valve failure undergoing ViV-TAVI. METHODS: Patients undergoing ViV-TAVI between 2007 and 2022 (52.5% of cases after 2015) at 3 German centers were included in this analysis. The co-primary outcome measures were technical success, device success, and early safety defined by VARC-3. Mortality was assessed up to 5 years. RESULTS: Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age, sex, clinically relevant baseline comorbidities, and surgical risk. Technical success (SL: 83.7% versus ST: 79.9%, p = 0.552), device success (SL: 67.4% versus ST: 54.3%, p = 0.105), and early safety (SL: 74.4% versus ST: 66.5%, p = 0.296) were comparable between groups. The 30-day mortality (SL: 7.0% versus ST: 2.6%, p = 0.136) and 5-year mortality rates (SL: 23.3% versus ST: 24.6%, p = 0.874) were not significantly different between groups. CONCLUSION: SL and ST ViV-TAVI led to comparable short-term outcomes according to VARC-3- defined endpoints and similar mortality rates up to 5 years of follow-up. VARC-3 defined technical success, device success, and early safety as well as 5-year all-cause mortality in patients undergoing valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) into stentless (SL) compared with stented (ST) failed aortic bioprostheses.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation.

INTRODUCTION: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. METHODS: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. RESULTS: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). CONCLUSION: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

High Residual Gradient Following a Self-Expandable Transcatheter Aortic Valve-in-Valve Implantation - Risk Factor Analysis, Outcomes, and Survival.

INTRODUCTION: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) can be associated with unfavorable hemodynamic outcomes. This study aimed to estimate the prevalence, identify the risk factors, and evaluate the outcomes and survival of patients with high residual gradients after TAVI-ViV. METHODS: A total of 85 patients were included in the study. The cohort was divided into group A, with postprocedural mean pressure gradient (PG) ≥ 20 mmHg, and group B, with mean PG < 20 mmHg. RESULTS: Postprocedural PG ≥ 20 mmHg was observed in 24.7% of the patients. In a univariate analysis, preoperative gradient, pre-existing patient-prosthesis mismatch (PPM), deep valve implantation, small degenerated valves, and an older generation of transcatheter aortic valves were found to be risk factors for high residual gradient. Multivariate analysis showed that preexisting maxPG > 60 mmHg, implantation level of 4 mm below neo-annulus, and degenerated valve size ≤ 23 mm were independent predictors of high residual gradient. There were no differences in early morbidity (myocardial infarction, pacemaker implantation, stroke, acute renal insufficiency) between groups. Kaplan-Meier estimated that the survival rate was comparable at one and five years regardless of postoperative gradient. Survivors with high residual mean gradient were significantly affected by a high New York Heart Association (NYHA) class. CONCLUSION: High residual transvalvular gradient after TAVI-ViV is not rare, but it does not significantly affect mortality. High residual mean gradient has a negative impact on NYHA functional class improvement after the procedure. High preoperative gradient, implantation level, and small failed bioprosthesis may predispose to increased residual gradient.

Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry.

OBJECTIVES: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. METHODS: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. RESULTS: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. CONCLUSIONS: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Five-box thoracoscopic maze based on the Gemini-S bipolar ablation device to treat atrial fibrillation.

Thoracoscopic atrial fibrillation ablation seeks to replicate the electrophysiological effects of more invasive, open surgical procedures. The authors present a lesion concept that includes isolation of the pulmonary veins, the left atrial posterior wall, and the superior vena cava, respectively, lines to inhibit perimitral and periauricular flutter circuits, and left atrial appendage closure. All lesions are tested for bidirectional block.

Outcome of medical therapy, repeat intervention, and mitral valve surgery after failed MitraClip therapy.

OBJECTIVES: Optimal treatment for residual mitral regurgitation (MR) after MitraClip failure is not clearly defined. We report our clinical experience and discuss treatment options. METHODS: Between January 2013 and January 2018, 37 patients (75 ± 8.9 years, 46% male) were admitted for symptomatic MR (grade 3.1 ± 0.47) diagnosed after previous MitraClip therapy. Clinical outcome of these patients, who underwent medical therapy alone (n = 8, M-group), repeat MitraClip therapy (n = 8, reMC group), or mitral valve surgery (n = 21, S-group) for residual MR, were retrospectively analyzed. RESULTS: Thirty-day survival was 88% (M-group), 100% (reMC-group), and 76% (S-group). The rate of discharge to home was 88% in the reMC-group, better than 38% in the M-group (p = 0.051) and 19% in the S-group (p < 0.001). Perioperative non-survivors in the S-group had high surgical risk with median logistic EuroSCORE of 64.6% (interquartile range 57.4%-87.0%); all died from low cardiac output syndrome or multiple organ failure. The main MR pathologies resulted from leaflet tear and tethering in the M-group, tethering in the reMC-group, and degenerative valve and leaflet tear in the S-group. Kaplan-Meier analysis of overall survival at 1 year showed better outcome for patients in the reMC-group (50%, 95% CI 15.2-77.5%) and S-group (47.6%, 95% CI 25.7-66.7%), as compared to those in the M-group (12.5%, 95% CI 0.70-42.3%) (log-rank test p = 0.108 and p = 0.167, respectively). CONCLUSION: Medical therapy alone after failed MitraClip therapy resulted in poor 1-year prognosis. In patients without extremely high surgical risk, repeat MitraClip therapy, or surgical revision MIGHT BE CONSIDERED depending on valve pathology and cardiac comorbidities.

Cardiac conduction abnormalities in patients with degenerated bioprostheses undergoing transcatheter aortic valve-in-valve implantations and their impact on long-term outcomes.

BACKGROUND: The relationship between preoperative cardiac conduction abnormalities (CCA) and long-term outcomes after transcatheter aortic valve-in-valve implantation (TAVI-VIV) remains unclear. The aim of the study was to evaluate the effects of preoperative CCA on mortality and morbidity after TAVI-VIV and to estimate the impact of new-onset CCA on postoperative outcomes. METHODS: Between 2011 and 2020, 201 patients with degenerated aortic bioprostheses were qualified for TAVI-VIV procedures in two German heart centers. Cases with previously implanted permanent rhythm-controlling devices were excluded (n = 53). A total of 148 subjects met the eligibility criteria and were divided into 2 study groups according to the presence of preexisting CCA (CCA (n = 84) and non-CCA (n = 64), respectively). Early and late mortality and morbidity were evaluated. Follow-up functional status was assessed according to New York Heart Association (NYHA) classification. RESULTS: There were no procedural deaths. TAVI-VIV related new-onset CCAs were observed in 35.8% patients. The 30-day permanent pacemaker implantation rate was 1.6% in non-CCA vs 9.5% in CCA group (p = 0.045). Preexisting right bundle-branch block (OR:5.01; 95%CI, 1.05-23.84) and first-degree atrioventricular block (OR:4.55; 95%CI, 1.10-18.73) were independent predictors of new pacemaker implantation. One-year and five-year probability of survival were comparable in CCA and non-CCA groups: 90.3% vs 91.8% and 68.2% vs 74.3%, respectively. Surviving patients with preexisting and new-onset CCA had a worse functional status according to NYHA classification at follow-up. CONCLUSION: Preexisting and new-onset postoperative CCAs did not affect early and late mortality after TAVI-VIV procedures, however, they may have a negative impact on late functional status.

EuroSCORE-predicted mortality and surgical judgment for interventional aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) is used as an alternative to conventional surgery in high-risk patients. The EuroSCORE quantifies the risk, and patients are selected for this procedure if their predicted mortality is high. The study aim was to evaluate the risk discrimination and calibration of the EuroSCORE, as well as the surgical judgment that is used when selecting the aortic valve replacement (AVR) approach. METHODS: Between 2003 and 2006, a total of 2757 patients underwent isolated, open AVR. The EuroSCORE was compared to the observed in-hospital mortality. A survey among surgeons assessed the relevance of patient-specific factors towards the approach of TAVI versus open AVR. RESULTS: Survivors of AVR had a lower additive EuroSCORE than non-survivors (7.2 +/- 3.34 versus 12.0 +/- 3.34; p < 0.001). The EuroSCORE demonstrated reasonable risk stratification (c-statistic 0.843, p < 0.001). However, none of the 67 non-survivors was correctly predicted (Hosmer-Lemeshow test; p < 0.001), and most patients with a high EuroSCORE survived AVR. The actual mortality was 2.8% as compared to a EuroSCORE-predicted mortality of 12.5 +/- 14.2% (p < 0.001). This poor calibration was worse with higher EuroSCOREs (Cusum test; p < 0.001). Surgeons identified a porcelain aorta as the only factor that warranted TAVI. Most EuroSCORE variables had either no relevance for treatment selection, or prompted open AVR. CONCLUSION: Patient selection for TAVI cannot be based on the EuroSCORE, because it lacks discrimination and center-specific calibration. Thus, individual, surgical judgment that weighs institutional expertise for high-risk patients against a possible reduction of mortality by using interventional techniques, is recommended.

[Electromyostimulation (EMS) in cardiac patients. Will EMS training be helpful in secondary prevention?]. / Elektromyostimulation (EMS) bei kardiologischen Patienten. Wird das EMS-Training bedeutsam für die Sekundärprävention?

BACKGROUND: Current guidelines concerning the treatment of patients with chronic congestive heart failure (CHF) include ergospirometry-directed dynamic exercises on a daily basis. Several prospective, randomized trials have confirmed its positive influence on clinical symptoms and prognosis of the disease. Patients with stable coronary artery disease (CAD) can benefit from a 27% reduction of mortality, as shown in meta-analyses of several studies. By contrast, patients with CHF have traditionally been discouraged from physical activities, which may have had detrimental consequences. They became even less able to participate in daily activities that in turn hastened the disease-driven atrophies of skeletal muscles. On the other hand, well-adjusted endurance training at 50-70% of maximum oxygen uptake was shown to improve overall fitness. In a recent metaanalysis, the mortality of patients with CHF was reduced by 35% by sports, and the rate of hospitalizations dropped by 28%. It is a well-perceived clinical problem that successful treatment is not possible without intensive guidance and a close therapeutic relationship. Being left in their routine situation and circumstances, the majority of patients cannot cope with the day-to-day challenge of an independent, active lifestyle. Among the primary reasons not to sustain physical activity are mental, psychological or social barriers. PATIENTS AND METHODS: The authors have begun, in a cohort of patients with CHF, a prospective pilot study to investigate the impact of, and attitude to, electromyostimulation (EMS). Unique features of this treatment include its passive nature that remains independent of mental attitude. RESULTS: An up to 96% increase of peak oxygen uptake at the anaerobic threshold could be shown (pre- vs. posttraining phase, VO(2at) 19.39 [+/- 5.3] ml/kg vs. 24.25 [+/- 6.34] ml/kg). The diastolic blood pressure decreased significantly. A 14% gain in muscle volume was observed, while overall body weight remained unchanged. All patients kept up the training until the conclusion of the study and found their overall fitness to be considerably improved. CONCLUSION: The results may indicate the enormous potential of EMS for the treatment of patients within the cardiologic arena, especially those with CHF.

Prevention of episodic migraines with topiramate: results from a non-interventional study in a general practice setting.

The majority of patients with migraine headaches are treated in non-specialized institutions though data on treatment outcomes are largely derived from tertiary care centers. The current non-interventional study explores efficacy and tolerability outcomes of patients with episodic migraines receiving topiramate as preventive agent in a general practice setting. A total of 366 patients (87% female, mean age 41.8 +/- 11.6 years) were eligible for migraine prevention and treated with flexible dose topiramate for 6 months (core phase), and optionally for a total of 12 months (follow-up phase). Overall, 261 patients (77.7% of safety analysis set, SAF) completed the core phase. Reasons for discontinuation included adverse events (2.1%), lost to follow-up (1.8%), other reasons (1.5%), and end of therapy (0.3%) though in the majority of patients who discontinued no reasons were listed. The median daily dose at endpoint was 50 mg/day (range, 25-187.5 mg/day). The median days with migraine headaches decreased from 6.0 to 1.2 days (p < 0.001), median pain intensity score decreased from 17.0 to 3.2 points (p < 0.001). In women with reported menstruation-associated migraine, the median number of migraine attacks decreased from 4.0 to 0.9 (p < 0.001). Absenteeism as well as triptan use decreased significantly, and significant improvements in activities of daily living and quality of life were reported. The most frequently reported AEs were paraesthesia (4.2%) and nausea (3%). Results suggest that migraine prevention with topiramate in a general practice is generally well tolerated and associated with a significant improvement in migraine headaches and related functional impairment.

Left-thoracoscopic Convergent ablation for atrial fibrillation.

Epicardial Convergent ablation followed by endocardial touch-up and an additional ablation may be superior to catheter-based interventions in patients with persistent atrial fibrillation. We sought to extend the epicardial lesion set by changing the standard subxiphoid thoracotomy to a left-lateral, totally thoracoscopic approach. This tutorial depicts a closed-chest, beating-heart procedure, including ablation of the left atrial posterior wall, the left atrial dome, and the left pulmonary veins. The left atrial appendage is closed using an epicardial occlusion device.

Impact of preinterventional tricuspid regurgitation on outcome of MitraClip therapy in patients with severely reduced ejection fraction.

Aim: To evaluate the impact of preinterventional moderate-to-severe functional tricuspid regurgitation (FTR) on early outcome after percutaneous edge-to-edge mitral valve repair (pMVR) with MitraClip procedures for functional mitral regurgitation (FMR) in patients with heart failure with reduced ejection fraction (HFrEF). Methods and results: From January 2013 to December 2017, 80 patients with HFrEF (ejection fraction 22%±5.3%) and FMR (grade 3.0±0.36) underwent successful pMVR. The 3-year actuarial survival was 58%. However, 73% (n=22) of non-survivors died of cardiac failure within 1 year. Patients were categorised into none-to-mild (n=36) and moderate-to-severe (n=44) postinterventional FTR groups according to pre-MitraClip tricuspid regurgitation grade. Cox regression analysis on 1-year survival demonstrated an impact of FTR severity (HR=1.8, 95% CI 1.01% to 3.09%, p=0.047), preoperative New York Heart Association class (HR=2.8, 95% CI 1.2% to 6.5%, p=0.015) and peripheral artery disease (HR=5.4, 95% CI 1.6 to 18, p=0.0054). Kaplan-Meier analysis showed that 1-year cardiac death was higher in the moderate-to-severe FTR group (p=0.048). In our study, 77% of pre-MitraClip moderate-to-severe FTR cannot be significantly reduced. Post-MitraClip moderate-to-severe FTR grade was related to lower survival (p<0.001). Conclusion: In patients with HFrEF treated with MitraClip for FMR, moderate-to-severe FTR was an independent predictor of cardiac death within 1 year. To improve survival, additional therapy to residual FTR should be considered in early phase after MitraClip therapy.

Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction.

AIMS: The aim of this study was to compare the outcomes of surgical mitral valve repair or replacement (sMVR) and percutaneous edge-to-edge repair using MitraClip (pMVR) in patients with severe left ventricular dysfunction affected by functional mitral regurgitation (FMR). METHODS AND RESULTS: We retrospectively identified 132 patients with left ventricular ejection fraction (LVEF) â‰¦ 30% submitted to sMVR (n = 47) or pMVR (n = 85) for FMR at our centre from January 2013 to December 2017. To adjust for baseline imbalances, we used a propensity score matching by age, logistic EuroSCORE, and left ventricular end-systolic volume. After being matched, MitraClip therapy showed lower perioperative mortality and rate of complications yet increased residual mitral regurgitation (MR) grade than did surgery (0.2 ± 0.50 in sMVR vs. 1.3 ± 0.88 in pMVR, P < 0.0001). According to stratified multivariate Cox model analysis, residual MR severity was an independent risk factor for cardiac death [hazard ratio (HR), 2.81; 95% confidence interval [CI], 1.44-5.48, P = 0.0025] and re-hospitalization for heart failure (HR, 3.07; 95% CI, 1.50-6.29, P = 0.0022) at 1 year follow-up. Stratified multivariable Cox regression analysis at 3 years identified pMVR as risk factor for cardiac death (HR, 0.19; 95% CI, 0.040-0.86, P = 0.031) and re-hospitalization for heart failure (HR, 0.28; 95% CI, 0.077-0.99, P = 0.048). CONCLUSIONS: In patients with FMR and LVEF ≤ 30%, MitraClip therapy resulted in lower perioperative complications and mortality than sMVR. However, surgically treated patients who survived the perioperative stage had less residual MR and experienced lower rates of re-hospitalization for heart failure at 1 year and lower cardiac mortality at 1 and 3 years of follow-up than did patients undergoing pMVR.

Femoral transcatheter valve-in-valve implantation as alternative strategy for failed aortic bioprostheses: A single-centre experience with long-term follow-up.

BACKGROUND: Surgical reoperation is still a standard procedure performed for degenerated aortic bioprostheses. On the other hand femoral minimally invasive valve-in-valve implantation (femTAVI-VIV) is an intriguing alternative. This clinical study was design to compare the early and late outcomes of redo-surgery (Redo-AVR) and femTAVI-VIV procedures for failed aortic bioprostheses. METHODS: We retrospectively reviewed 108 patients with degenerated aortic bioprostheses qualified for isolated Redo-AVR (n = 40) or femTAVI-VIV (n = 68) between 2003 and 2018. Both cohorts were divided into intermediate and high-risk groups according to the EuroSCORE II (4-9% and >9%). Propensity score matching selected 20 pairs in Intermediate-risk group and 10 pairs in High-risk group for the final comparison. RESULTS: Patients qualified for femTAVI-VIV were older (79.2 vs 72.9 years, p < 0.001) and at higher risk (EuroSCORE II 10.9 vs 7.8%, p = 0.005) than Redo-AVR subjects. Overall survival in femTAVI-VIV and Redo-AVR was comparable at 30-days, 1- and 5-years, respectively (92.6% vs 92.5%, 85.2% vs 85.0% and 62.9% vs 72.5%, p = 0.287). After PSM no differences in mortality, myocardial infarction, pacemaker implantation, stroke or acute renal insufficiency were found. Transcatheter procedure was associated with shorter hospital stay, lower rate of blood products transfusions and higher incidence of mild paravalvular leaks. CONCLUSION: Our study supports the opinion that transcatheter approach for treatment of patients with degenerated aortic bioprostheses is a safe alternative to Redo-AVR procedures particularly for those at high-risk.

Surgical repair of an uncontrolled thrombus caused by the Watchman device.

A device-related thrombus is a very common complication after the implantation of a Watchman device. Although anticoagulation therapy is the standard first choice therapy for a device-related thrombus, complications related to bleeding or existence of non-responders to the anticoagulation therapy are reported. Therefore, the possibility of another treatment, including surgical repair, needs to be discussed in the population unsuccessfully treated with anticoagulation therapy. We performed device-related thrombus removal and covered the orifice of the left atrial appendage with an autologous pericardial patch in 2 cases involving non-responders to anticoagulation therapy. Herein, we describe the technique and results of our experience with these 2 patients. The covering technique with an autologous pericardial patch is simple but highly efficient in preventing recurrent thrombus formation.