Venous Vascular Closure System Versus Figure-of-Eight Suture Following Atrial Fibrillation Ablation - The STYLE-AF Study.

BACKGROUND: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCS) were introduced into clinical practice, aiming to reduce the time of bedrest, to increase the patients' comfort and to reduce vascular access-related complications. AIMS: To compare the safety and efficacy of using a VCS to achieve haemostasis following single shot PVI to the actual standard of care (figure-of-eight suture and manual compression (MC)). METHODS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at 3 German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. RESULTS: A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation (109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; p<0.001), shorter time to haemostasis (1 (1, 2) vs. 5 (2, 10) min; p<0.001) and shorter time to discharge eligibility (270 (270, 270) vs. 340 (300, 458) min; p<0.001). No major vascular access related complication was reported in either group. A trend towards a lower incidence of minor vascular access related complications on the day of procedure was observed in the VCS group (7 (11.1%) vs. 15 (24.2%); p=0.063) as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis and time to discharge eligibility. No major vascular access related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access related complications.

[New ESC guidelines 2019 for the treatment of supraventricular tachycardia]. / Neue ESC-Leitlinien 2019 zur Behandlung von supraventrikulären Tachykardien.

The new guidelines for the management of supraventricular tachycardia (SVT) were published by the European Society of Cardiology (ESC) in September 2019. The key message of the guidelines is that catheter ablation should be offered as a first line treatment to most patients during a comprehensive discussion of the risks and advantages. This recommendation recognizes that catheter ablation has nowadays become a widely established, effective and safe treatment method with a very low complication rate, which has revolutionized the treatment of SVT due to the substantial technical developments in recent years. The new guidelines also include a refinement of the recommendations for the use of antiarrhythmic drug treatment. Most of the previously used medications have been downgraded based on the currently available evidence situation. The recommendations suggest that with the exception of beta blockers and calcium channel blockers, most drugs used to treat SVT are proarrhythmogenic. The occurrence of SVT is associated with a higher risk of complications during pregnancy and the new guidelines provide new and specific recommendations for this patient group. It must be emphasized that all antiarrhythmic drugs should be avoided during the first trimester of pregnancy. It is important to realize that if drug treatment is ineffective, contraindicated or undesired, pregnant women with persistent or recurrent arrhythmia can now be treated with catheter ablation using new techniques that avoid exposing the patient and the fetus to hazardous levels of radiation.

Health related quality of life after extracorporeal cardiopulmonary resuscitation in refractory cardiac arrest.

BACKGROUND: Recent data identifies extracorporeal cardio-pulmonary resuscitation (eCPR) as a potential addendum of conventional cardiopulmonary-resuscitation (cCPR) in highly specified circumstances and selected patients. However, consented criteria indicating eCPR are lacking. Therefore we provide first insights into the health-related quality of life (HRQoL) outcomes of patients treated with eCPR in a real world setting. METHODS: Retrospective single-center experience of 60 consecutive patients treated with eCPR between 01/2014 and 06/2016 providing 1-year survival- and HRQoL data obtained through the Short-Form 36 Survey (SF-36) after refractory out-of-hospital- (OHCA) and in-hospital cardiac arrest (IHCA) of presumed cardiac etiology. RESULTS: Resuscitation efforts until initiation of eCPR averaged 66 ±â€¯35 min and 63.3% of the patients suffered from OHCA. Fifty-five (91.7%) of the overall events were witnessed and bystander-CPR was performed in 73.3% (n = 44) of cases. Cause of arrest was dominated by acute myocardial infarction (AMI, 66.7%) and initial rhythm slightly outbalanced by ventricular fibrillation/tachycardia (VF/VT 53.3%). 12-month survival was 31%. Survivors experienced more often bystander-CPR (p = .001) and a shorter duration of cCPR (p = .002). While mid-term survivors' perceived HRQoL was compromised compared to controls (p ≦ .0001 for PF, RP, RE and BP; p = .007 for GH; p = .016 for SF; p = .030 for MH; p = .108 for VT), scores however resembled HRQoL of subjects on hemodialysis, following cardiogenic shock or pulmonary failure treated with extracorporeal membrane oxygenation (ECMO). CONCLUSIONS: While HRQoL scores of our survivors ranged markedly below controls, compared to patients on chronic hemodialysis, following ECMO for cardiogenic shock or pulmonary failure most of the discrepancies ameliorated. Thus, successfull eCPR in properly selected patients does translate into an encouraging HRQoL approximating chronic renal failure.

[Cardiac arrest in a fitness trainer with apical hypertrophic cardiomyopathy associated with cor triatriatum sinister]. / Plötzlicher Herztod einer Fitnesstrainerin mit hypertropher Kardiomyopathie vom apikalen Typ assoziiert mit Cor triatriatum sinister.

We report on a 49-year-old fitness trainer, who was admitted to our hospital after cardiac arrest due to ventricular fibrillation. Return of spontaneous circulation was achieved after immediate cardiopulmonary resuscitation. Coronary angiography could exclude coronary artery disease. Echocardiography demonstrated the presence of apical hypertrophic cardiomyopathy, associated with cor triatriatum sinister. Cardiac magnetic resonance imaging additionally showed marked myocardial fibrosis. The patient underwent placement of an implantable cardioverter-defibrillator and was subsequently discharged for rehabilitation in good condition.

Predictors of Atrial Fibrillation Recurrence after Catheter Ablation: Data from the German Ablation Registry.

Catheter ablation (CA) for atrial fibrillation (AF) has emerged as a widespread first or second line treatment option. However, up to 45% of patients (pts) show recurrence of AF within 12 month after CA. We present prospective multicenter registry data comparing characteristics of pts with and without recurrence of AF within the first year after CA. This study comprises all pts with complete follow-up one year after CA (1-y-FU; n = 3679). During 1y-FU in 1687 (45.9%) pts recurrence of AF occurred. The multivariate analysis revealed female sex and AF type prior to the procedure as predictors for AF recurrence. Furthermore, comorbidities such as valvular heart disease and renal failure as well as an early AF relapse were also predictors of AF recurrence during 1-y-FU. However, despite an AF recurrence rate of 45.9%, the majority of these pts (72.4%) reported a significant alleviation of clinical symptoms. In conclusion in pts with initially successful CA for AF female sex, AF type, in-hospital AF relapse and comorbidities such as renal failure and valvular heart disease are independent predictors for AF recurrence during 1-y-FU. However, the majority of pts deemed their interventions as successful with significant reduction of symptoms irrespective of AF.

[Interventional catheter treatment of tricuspid valve regurgitation]. / Katheterinterventionelle Therapie der Trikuspidalklappeninsuffizienz.

BACKGROUND: The tricuspid valve can be considered the "forgotten" valve because in the past hardly any research has been conducted in this field and as a result only few therapeutic options existed. The prognosis of untreated tricuspid regurgitation (TR) is poor and mortality is high for patients with severe TR. Patients frequently return to medical practices and hospitals because of cardiac decompensation, with shortness of breath and leg edema. OBJECTIVE: Recent years have seen more development in catheter-based treatment options. Currently, several devices are in clinical evaluation, which are presented in this article. MATERIAL AND METHODS: A web-based literature search was carried out and information was gathered at international cardiology meetings (TCT 2016 in Washington, DGK 2017 in Mannheim, EuroPCR 2017 in Paris). RESULTS AND CONCLUSION: There are various options for interventional catheter procedures for TR, which are being investigated within the scope of clinical studies. Most aim at reducing the tricuspid annular diameter and optimizing leaflet coaptation. Because of these new therapy options patients can now be treated who were considered untreatable in the past because of the high perioperative mortality.

Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left ventricular systolic dysfunction.

INTRODUCTION: Heart failure is a major cause of morbidity and mortality throughout the world. Despite advances in therapy, nearly half of patients receiving guideline-directed medical therapy remain limited by symptoms. Cardiac contractility modulation (CCM) can improve symptoms in this population, but efficacy and safety in prospective studies has been limited to 12 months of follow-up. We report on the first 2 year multi-site evaluation of CCM in patients with heart failure. METHODS: One hundred and forty-three subjects with heart failure and reduced ejection fraction were followed via clinical registry for 24 months recording NYHA class, MLWHFQ score, 6 min walk distance, LVEF, and peak VO2 at baseline and 6 month intervals as clinically indicated. Serious adverse events, and all cause as well as cardiovascular mortality were recorded. Data are presented stratified by LVEF (all subjects, LVEF <35%, LVEF ≥35%). RESULTS: One hundred and six subjects from 24 sites completed the 24 month follow-up. Baseline parameters were similar among LVEF groups. NYHA and MLWHFQ improved in all 3 groups at each time point. LVEF in the entire cohort improved 2.5, 2.9, 5.0, and 4.9% at 6, 12, 18, and 24 months, respectively. Insufficient numbers of subjects had follow-up data for 6 min walk or peak VO2 assessment, precluding comparative analysis. Serious adverse events (n = 193) were observed in 91 subjects and similarly distributed between groups with LVEF <35% and LVEF ≥35%, and similar to other device trials for heart failure. Eighteen deaths (7 cardiovascularly related) over 2 years. Overall survival at 2 years was 86.4% (95% confidence intervals: 79.3, 91.2%). CONCLUSION: Cardiac contractility modulation provides safe and effective long-term symptomatic and functional improvement in heart failure. These benefits were independent of baseline LVEF and were associated with a safety profile similar to published device trials.

[New strategies and technologies for ablation of atrial fibrillation : Where do we go?] / Neue Strategien und Technologien für die Ablation von Vorhofflimmern : "Where do we go?".

Catheter-based ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation is the established cornerstone of all ablation strategies. However, the rate of electrical reconduction of previously isolated pulmonary veins is high and associated with recurrence of AF. Novel and innovative mapping and ablation systems are being developed or are under clinical evaluation aiming for higher durability of pulmonary vein isolation. Additional ablation strategies for patients with recurrence of AF despite persistent isolation of the pulmonary veins are under evaluation. These ablation strategies include ablation of complex fractionated atrial electrograms, linear lesions, rotors or drivers, fibrotic areas or ablation of extrapulmonary triggers. The true clinical benefit of these additional ablation strategies can only be assessed if the pulmonary veins are persistently isolated.

[Catheter ablation of persistent atrial fibrillation : Where do we go?] / Katheterablation von persistierendem Vorhofflimmern : "Where do we go?".

Despite the very promising initial results of clinical studies, catheter ablation of persistent atrial fibrillation (AF) remains a challenge in modern electrophysiology. On the basis of the hypothesized pathophysiological mechanisms, a variety of ablation strategies have been developed over the course of time. The current ablation strategies range from pulmonary vein isolation (PVI) alone as first-line therapy, through ablation of multiple linear lesions, ablation of complex fractionated atrial electrograms (CFAE), rotor ablation, isolation of fibrotic and scar tissue up to isolation of the left atrial appendage (LAA); however, it is unclear even to the present day whether these complex and time-consuming strategies actually improve the success rate of ablation therapy. In recent years it has reproducibly been shown that with these ablation techniques more than one procedure is often necessary in order to achieve a stable sinus rhythm and even then only limited satisfactory success rates can be expected. The only currently established ablation endpoint is PVI. The stringent treatment of risk factors, such as arterial hypertension and obesity is becoming a focus of interest as an additive concept to ablation.

[Pulmonary vein isolation for atrial fibrillation : Findings from long-term follow-up]. / Pulmonalvenenisolation bei Vorhofflimmern : Erkenntnisse aus klinischen Langzeitdaten.

Atrial fibrillation is by far the most common cardiac arrhythmia in humans. The incidence of atrial fibrillation increases with age and will increase even more in the future due to the demographic changes in the population. Therefore, this arrhythmia will have a growing clinical and socioeconomic impact. Although there are established pharmaceutical treatment options, atrial fibrillation is one of the major causes of stroke, heart failure and cardiovascular morbidity and mortality. The latest guidelines recommend the invasive procedure of circumferential pulmonary vein isolation (PVI) as an effective treatment of paroxysmal and persistent atrial fibrillation. This article summarizes the current long-term follow-up data after PVI.

[Choosing wisely recommendations in cardiology]. / Klug-entscheiden-Empfehlungen in der Kardiologie.

This article describes controversially discussed Choosing wisely recommendations presented by the German Cardiac Society: anticoagulation therapy in patients with atrial fibrillation and "only" moderate stroke risk, on the one hand, and goal-directed low-density lipoprotein (LDL) cholesterol-lowering, on the other. Presuming an adequate regime, patients with atrial fibrillation and only moderate risk of stroke (CHA2DS2-VASc Score of 1 in men and of 2 in women) also benefit from anticoagulation therapy, even in elderly patients. In patients with coronary heart disease, the German Cardiac Society recommends reducing LDL-cholesterol serum levels with a statin to values lower than 70 mg/dl (1.8 mmol/l) or at least reducing the basal level by 50%. With this recommendation, the German Cardiac Society unequivocally prioritizes the "goal-oriented statin therapy" above the "statin strategy of fixed dose". The reasons for this preference are discussed.

[Radiofrequency current or cryoballoon for ablation of atrial fibrillation? : Hot or cold?] / Hochfrequenzstrom oder Cryoballon für die Ablation von Vorhofflimmern? : "Hot or cold?".

Atrial fibrillation (AF) is the most common form of cardiac arrhythmia. The aim of therapy in symptomatic patients is the establishment of a stable sinus rhythm (SR). Catheter ablation with isolation of the pulmonary veins is the essential component of all forms of ablation therapy and provides the most effective treatment option. The most frequently used technologies for pulmonary vein isolation (PVI) are radiofrequency current (RFC)-based and cryoballoon (CB)-guided ablation. Irrespective of the simplification of PVI, CB ablation is characterized by a short learning curve and short procedural times and demonstrated non-inferiority with respect to safety and efficacy when directly compared to RFC ablation for the treatment of patients with paroxysmal AF; however, the clinical outcome in patients with persistent AF is often insufficient when performing pulmonary vein isolation (PVI) alone for stabilization of SR. Differentiated RFC ablation is the treatment of choice when performing additional ablation strategies beyond PVI in order to improve clinical results with freedom from arrhythmia recurrence.

Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients.

OBJECTIVES: Transcatheter Aortic Valve Implantation (TAVI) can be performed via the transaxillary approach, but data about complications and procedural outcome is limited. INTRODUCTION: TAVI is an established treatment option for patients at high risk for conventional aortic valve replacement. Nowadays, the transfemoral approach is the most commonly used access for TAVI. Nevertheless, the transfemoral access is not suitable in many patients necessitating alternative approaches. METHODS: We analyzed the outcome of 100 consecutive cases receiving percutaneous transaxillary TAVI at two different hospitals. Data were retrospectively analyzed by means of procedural, hemodynamic and clinical outcome. In addition, 1st versus 2nd generation devices were analyzed. RESULTS: Mean age was 78.2±2.1years and the logEuroSCORE I was 24.6±13.9%. Transaxillary TAVI was performed in 85% via the left and in 15% via the right axillary artery. Device success was achieved in 95%. In general, there was a clear learning curve with this approach. No patient experienced a major and 11% a minor access site complication. There was one procedural death (annular rupture) and one peri-procedural TIA. 23% of the patients received a new pacemaker. At discharge, effective orifice area was 1.94±0.16cm2 and the mean aortic gradient was 6.8±2.1mmHg. Moderate aortic regurgitation/paravalvular leakage was documented in two patients. Mortality rates at 30days and one year were 6% and 14.8%. Last but not least, 2nd generation devices showed improved procedural outcomes. CONCLUSIONS: The percutaneous transaxillary access for TAVI is technically feasible and safe thereby yielding excellent clinical results. CONDENSED ABSTRACT: We investigated In 100 consecutive patients undergoing percutaneous transaxillary transcatheter aortic valve implantation thereby demonstrating that this approach is technically feasible and safe with acceptable numbers of minor vascular complications.

What have we learned of ablation procedures for atrial fibrillation?

Atrial fibrillation is a widespread disease of growing clinical, economic and social importance. Interventional therapy for atrial fibrillation offers encouraging results, with pulmonary vein isolation (PVI) as the established cornerstone. Yet, the challenge to create durable transmural lesions remains, leading to recurrence of atrial fibrillation in long-term follow-up even after multiple ablation procedures in 20% of patients with paroxysmal atrial fibrillation and approximately 50% with persistent atrial fibrillation. To overcome these limitations, innovative tools such as the cryoballoon and contact force catheters have been introduced and have demonstrated their potential for safe and effective PVI. Furthermore, advanced pharmacological and pacing manoeuvres enhance evaluation of conduction block in PVI.

[Future interventional procedures for valve diseases]. / Zukünftige interventionelle Verfahren bei Herzklappenerkrankungen.

BACKGROUND: Percutaneous valve therapies represent one of the most innovative areas within interventional cardiology in the past 10 years. AIM: The aim of this work is to give an overview of current and upcoming therapeutic options. MATERIALS AND METHODS: In this manuscript, the results of a retro- and prospective literature research are summarized. RESULTS AND DISCUSSION: With the introduction of percutaneous therapies for valvular heart disease, patients who were previously considered too ill for surgery can now be treated. The percutaneous treatment of aortic or mitral valve disease has become standard therapy. Likewise, promising results have been obtained for percutaneous treatment options for pathologies of the tricuspid valve, which are still under intense investigation.

[ESC guidelines 2015 for ventricular arrhythmias and prevention of sudden cardiac death. What is new?]. / ESC-Leitlinien 2015 zu ventrikulären Arrhythmien und zur Prävention des plötzlichen Herztodes. Was ist neu?

The new European Society of Cardiology (ESC) guidelines for the management of patients with ventricular arrhythmia and the prevention of sudden cardiac death, recently published at the annual ESC meeting in London, contain an extensive update of the recommendations for the diagnostics, drug therapy, interventional and device therapy of ventricular arrhythmia. The new recommendations for implantable cardioverter defibrillator (ICD) treatment for primary and secondary prophylaxis of sudden cardiac death can be seen as a focused update of the previously published guidelines. Pre-existing recommendations for catheter ablation of ventricular arrhythmias have been partly extensively expanded with respect to the results of recent clinical trials. The guideline committee also adapted their recommendations regarding the hereditary arrhythmia syndromes to the 2013 consensus report of the American Heart Association (AHA), the European Heart Rhythm Association (EHRA) and the Asia Pacific Heart Rhythm Society (APHRS).

[Mitral valve interventions: Where do we stand?]. / Mitralklappeninterventionen : Wo stehen wir?

Mitral valve regurgitation (MR) with resulting heart failure is one of the most prevalent types of valvular heart disease. Currently, various approaches to catheter-based therapy of MR are already available for patients deemed to be at high-risk for surgery. Most experience has been gained with the MitraClip® system. Technological developments in the field of catheter-based treatment of MR is advancing at a rapid pace, with treatment modalities suited for patients with both primary and secondary MR. Annuloplasty is the surgical gold standard, particularly for patients with secondary MR. For catheter-based therapy of secondary MR a distinction is made between indirect and direct annuloplasty, with the latter most closely corresponding to surgical ring implantation. Catheter-based mitral valve replacement is technically feasible at present; however, experience is still limited and only few reports have been published. Technological development is markedly slower than in the field of transcatheter aortic valve replacement, predominantly owing to the far more complex structure of the mitral valve. Positive experience has already been gained with catheter-based implantation of prostheses designed for the aortic valve into degenerated mitral valve bioprostheses and failed surgical mitral annuloplasty rings (valve-in-valve and valve-in-ring implantation). Further approaches to catheter-based treatment of MR in high-risk surgical patients are expected in the future.