Cardiac tamponade complicating ventricular arrhythmia ablation: Real life data on incidence, management, and outcome.

BACKGROUND AND OBJECTIVE: Cardiac tamponade during ablation procedures is a life-threatening complication. While the incidence and management of tamponade in atrial fibrillation ablation have been extensively described, the data on tamponade during ventricular ablations are very limited. The purpose of this study is to shed light on the incidence, typical perforation sites, and optimal management as observed through real-life data in a tertiary referral center for ventricular ablation. METHODS AND RESULTS: Consecutive patients with structural heart disease undergoing ventricular tachycardia ablation from 2008-2020 were analyzed. Of the 1078 patients undergoing 1287 ventricular ablation procedures, 20 procedures (1.5%) were complicated by cardiac tamponade. In all but one patient, the tamponade was treated with emergent pericardial drainage, while nine patients eventually underwent surgical repair. The perforation occurred during transseptal or subxiphoid puncture in six patients, during ventricle mapping in two patients, and during ablation in five patients (predominantly basal left ventricle). Steam pop as definite perforation cause could only be established in two patients. Regardless of the management of the complication, all patients survived to discharge. CONCLUSION: Cardiac tamponade during ventricular ablation occurred in 1.5% of the procedures. In nine patients cardiac repair was necessary. Perforation was mostly associated with subxiphoid puncture or ablation of the basal left ventricle.

Relevance of Chronic Total Occlusion for Outcome of Ventricular Tachycardia Ablation in Ischemic Cardiomyopathy.

Background: Catheter ablation of ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) is an effective tool to prevent VT recurrences. Chronic total occlusion (CTO) represents a clinically relevant entity in ICM patients and is an independent predictor of ventricular arrhythmia and mortality. The effects of CTO on the outcome of VT ablation are not well-studied. Objective: This analysis aimed to identify the impact of CTO, revascularized, or not revascularized, on the outcome of VT ablation. Methods and Results: Of 385 consecutive subjects with ICM-VT who underwent catheter VT ablation for monomorphic VT at Heart Center Leipzig between 2008 and 2017, 108 patients without CTO and 191 patients with CTO were included in the analysis. Within a median follow-up time of 557 days (IQR 149, 1095), VT recurred in 77 (40%) patients in the CTO and 40 (37.0%) in the non-CTO cohort (p = 0.62). In a multivariable model, a 10% stepwise change in LVEF as well as ICD on admission was associated with VT recurrence (HRadj 1.82, 95% CI 1.04-3.18 and HRadj 1.35, 95% CI 1.23-1.61, respectively). Of the CTO cohort before ablation, 45% had received revascularization, which was independently associated with a higher risk for VT recurrence (HR 2.12, 95% CI 1.35-3.34) as compared to nonrevascularized CTO. Conclusion: In ICM patients with and without CTO, VT ablation was associated with equal effectiveness with regard to VT recurrence. However, in revascularized CTO patients, the risk of recurrence of VT after ablation was significantly increased.

A randomized trial of non-fasting vs. fasting for cardiac implantable electronic device procedures (Fast-CIED Study).

AIMS: Data on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient's well-being and safety in elective cardiac implantable electronic device (CIED) procedures. METHODS AND RESULTS: In this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients' well-being scores (based on numeric rating scale, 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients' well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) -6.35 to -0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD -2.86 to -1.42, P < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD -1.68 to -0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. CONCLUSION: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient's well-being and comparable in terms of safety for CIED procedures (NCT04389697).

Mind and body interventions in cardiology : The importance of the brain-heart connection.

Mind and body interventions aim to harness the "relaxation response", reduce stress, and improve quality of life, which is important in the search for more holistic treatment approaches in cardiovascular medicine. This article describes the pertinent pathophysiological correlates building the mechanistic backbone for these interventions. They can be found in the complex connections of brain and heart (central and autonomic nervous system, hypothalamic-pituitary-adrenal axis), which play an important role in the development of various cardiovascular disease conditions and hold potential as therapeutic targets. The evidence regarding the effect of mind and body interventions in cardiology with a focus on arrhythmia and psychocardiology is reviewed systematically. To date, mostly small pilot studies prone to substantial bias and without adequate power have dominated the field and longer-term outcome data are lacking. Ultimately, integration of mind and body interventions could empower patients by strengthening their individual responsibility and mental power in addition to the benefits of stress reduction and improvement of quality of life. Whether this will translate into relevant longer-term clinical outcomes remains uncertain. Therefore, this field offers multifaceted opportunities for further research and practical applications.

[Long-term course of heart disease: How can psychosocial care be improved?] / Herzerkrankungen im Langzeitverlauf: Wie kann die psychosoziale Versorgung verbessert werden?

Cardiovascular diseases, which primarily include coronary artery disease (CAD), heart failure (HF) and cardiac arrhythmias, are the leading causes of death in the European Union and responsible for most of the serious courses of coronary disease. Acute events are usually the focus of clinical attention. In contrast, there are hardly any structured care and therapy concepts for the long-term course of these diseases. Based on a literature review, this article provides an overview of the long-term consequences and long-term care of heart diseases. Deficits in the psychosocial care of patients and possible solutions are discussed.Patients with CAD often experience problems with medication adherence and compliance to behavioural recommendations due to inadequate long-term psychosocial care. Psychological comorbidities reduce the quality of life and are a driver for health-damaging behaviour. Patients with cardiac arrhythmias often get into a vicious circle of recurrent physical complaints interacting with anxiety and panic attacks and the associated use of outpatient, emergency, or inpatient care facilities. In the course of heart failure, a clinically significant growing number of patients are treated with antidepressants, the benefit of which is rather doubtful.The apparent deficits in long-term psychosocial care of cardiovascular disease and the quality of life of patients could be improved through the increased use of systematic collaborative care models by specialised care facilities with the involvement of general practitioners.

Gender differences in patients with structural heart disease undergoing VT ablation.

INTRODUCTION: This study sought to examine gender differences in patients with structural heart disease (SHD) referred for ablation of ventricular tachycardia (VT). BACKGROUND: Female patients are often underrepresented in large studies. Significant differences in the clinical presentation, treatment, and prognosis of female patients have been described in previous studies. METHODS AND RESULTS: We investigated 88 female patients with SHD undergoing VT ablation (mean age 59 years, 56% nonischemic cardiomyopathy, mean left ventricular ejection fraction 35%, 82% in electrical storm). A case-control study with 88 male patients was performed and the results regarding clinical and procedural characteristics, acute and long-term results of the two groups were compared. The female patients had more arrhythmogenic substrate, as they more commonly presented with electrical storm (p = .016) and had a higher number of inducible VT morphologies during the procedure (p = .018). Moreover, the female patients were less likely to have an optimized heart failure medical treatment at baseline (p = .030) and required more time from the first manifestation of the VT to ablation referral (p = .034). Although fewer epicardial ablations were performed in female patients (p = .019), the two groups showed similar results regarding VT noninducibility as ablation endpoint (p = .844), major procedure-related complications (p = .719) and freedom from VT during follow-up (p = .268). Moreover, the overall mortality in the two groups was similar (p = .176). Advanced NYHA class was associated with worse transplant and assist-device-free survival in the female group. CONCLUSION: Female patients presenting for VT ablation had more arrhythmogenic substrate and were less likely to have an optimized heart failure medical treatment. Nevertheless, the procedural acute and long-term outcomes between the two genders were similar.

Epicardial ablation of ventricular tachycardia in patients with structural heart disease: a single-centre experience over 12 years.

AIMS: Epicardial ablation has risen to an essential part of the treatment of ventricular tachycardias (VTs). In this study, we report the efficacy, risks, and current trends of epicardial ablation in structural heart disease as reported in a tertiary single centre over a 12-year period. METHODS AND RESULTS: Two hundred and thirty-six patients referred for VT ablation underwent a successful epicardial access and were included in the analysis (89% non-ischaemic cardiomyopathy, 90% males, mean age 60 years, mean left ventricular ejection fraction 38.4%). After performing epicardial ablation the clinical VTs were eliminated in 87% of the patients and 71% of the cohort achieved freedom from VT during 22-month follow-up. Twelve patients (5%) suffered major procedure-related complications. Until the end of follow-up 47 (20%) patients died, 9 (4%) underwent a left ventricular assist device implantation and 10 (4%) patients received a heart transplantation. Antiarrhythmic drugs at baseline and during follow-up were independent predictors of VT recurrence. Atrial fibrillation, renal dysfunction, worse New York Heart Association class, and antiarrhythmic drugs at follow-up were associated with worse survival in our cohort. CONCLUSION: In this large tertiary single-centre experience, percutaneous epicardial access was feasible in the large majority of the cohort with acceptably low complications rates. A combined endo-/epicardial approach resulted in 87% acute and 71% long-term success. Further studies are needed to clarify the role of routine combined endo-/epicardial ablation in these complex cardiomyopathies.

Predictors of long-term mortality after catheter ablation of ventricular tachycardia in a contemporary cohort of patients with structural heart disease.

AIMS: Ablation of ventricular tachycardias (VTs) in patients with structural heart disease has been established in the past decades as an effective and safe treatment. However, the prognosis and long-term outcome remains poor. METHODS AND RESULTS: We investigated 309 patients with ischaemic cardiomyopathy (ICM) and non-ischaemic cardiomyopathy (NICM) (186 ICM, 123 NICM; 271 males; mean age 64.1 ± 12 years; ejection fraction 34 ± 13%) after ≥1 VT ablations over a mean follow-up period of 34 ± 28 months. Electrical storm was the indication for 224 patients (73%), whereas 86 patients (28%) underwent epicardial as well as endocardial ablation. During follow-up, 132 patients (43%) experienced VT recurrence and 97 (31%) died. Ischaemic cardiomyopathy and NICM patients showed comparable results, regarding procedural endpoints, complications, VT recurrence and survival. The Cox-regression analysis for all-cause mortality revealed that the presence of higher left ventricular end-diastolic volume (LVEDV; P < 0.001), male gender (P = 0.018), atrial fibrillation (AF; P < 0.001), chronic obstructive pulmonary disease (COPD; P = 0.001), antiarrhythmic drugs during the follow-up (P < 0.001), polymorphic VTs (P = 0.028), and periprocedural complications (P = 0.001) were independent predictors of mortality. CONCLUSION: Ischaemic cardiomyopathy and NICM patients undergoing VT ablation had comparable results regarding procedural endpoints, complications, VT recurrence and 3-year mortality. Higher LVEDV, male gender, COPD, AF, polymorphic VTs, use of antiarrhythmics, and periprocedural complications are strong and independent predictors for increased mortality. The PAINESD score accurately predicted the long-term outcome in our cohort.

Cardiac MRI and Texture Analysis of Myocardial T1 and T2 Maps in Myocarditis with Acute versus Chronic Symptoms of Heart Failure.

BackgroundThe establishment of a timely and correct diagnosis in heart failure-like myocarditis remains one of the most challenging in clinical cardiology.PurposeTo assess the diagnostic potential of texture analysis in heart failure-like myocarditis with comparison to endomyocardial biopsy (EMB) as the reference standard.Materials and MethodsSeventy-one study participants from the Magnetic Resonance Imaging in Myocarditis (MyoRacer) trial (ClinicalTrials.gov registration no. NCT02177630) with clinical suspicion for myocarditis and symptoms of heart failure were prospectively included (from August 2012 to May 2015) in the study. Participants underwent biventricular EMB and cardiac MRI at 1.5 T, including native T1 and T2 mapping and standard Lake Louise criteria. Texture analysis was applied on T1 and T2 maps by using an open-source software. Stepwise dimension reduction was performed for selecting features enabling the diagnosis of myocarditis. Diagnostic performance was assessed from the area under the curve (AUC) from receiver operating characteristic analyses with 10-fold cross validation.ResultsIn participants with acute heart failure-like myocarditis (n = 31; mean age, 47 years ± 17; 10 women), the texture feature GrayLevelNonUniformity from T2 maps (T2_GLNU) showed diagnostic performance similar to that of mean myocardial T2 time (AUC, 0.69 for both). The combination of mean T2 time and T2_GLNU had the highest AUC (0.76; 95% confidence interval [CI]: 0.43, 0.95), with sensitivity of 81% (25 of 31) and specificity of 71% (22 of 31). In patients with chronic heart failure-like myocarditis (n = 40; mean age, 48 years ± 13; 12 women), the histogram feature T2_kurtosis demonstrated superior diagnostic performance compared to that of all other single parameters (AUC, 0.81; 95% CI: 0.66, 0.96). The combination of the two texture features, T2_kurtosis and the GrayLevelNonUniformity from T1, had the highest diagnostic performance (AUC, 0.85; 95% CI: 0.57, 0.90; sensitivity, 90% [36 of 40]; and specificity, 72% [29 of 40]).ConclusionIn this proof-of-concept study, texture analysis applied on cardiac MRI T1 and T2 mapping delivers quantitative imaging parameters for the diagnosis of acute or chronic heart failure-like myocarditis and might be superior to Lake Louise criteria or averaged myocardial T1 or T2 values.© RSNA, 2019Online supplemental material is available for this article.See also the editorial by de Roos in this issue.

Complex cases of acquired pulmonary vein stenosis after radiofrequency ablation: is surgical repair an option?

AIMS: Results of catheter based interventional treatment for pulmonary vein stenosis (PVS) following radiofrequency ablation (RFA) for atrial fibrillation remain suboptimal. Surgical repair may represent an alternative therapy, though long-term results have not been thoroughly investigated. METHODS AND RESULTS: We retrospectively assessed all patients in our centre undergoing surgical repair for radiofrequency-induced PVS. Data regarding surgical technique, clinical outcome, and rate of pulmonary vein (PV) restenosis were collected and analysed. Between 2004 and 2016, the rate for PVS resulting from RFA for atrial fibrillation in our institution was 0.79% (76/9633). During this period, five male patients with multiple PVS (3 ± 1) underwent surgical repair of a total of 13 symptomatic PVS. Surgery was performed in a standard setting under cardiopulmonary bypass. Stenotic veins were incised longitudinally followed by a patch augmentation plasty using either bovine pericard (n = 7) or polytetrafluoroethylene (PTFE) patches (n = 5). Localization of incision was on the anterior side of the PV only (n = 8) or on both the anterior and posterior sides (n = 4). In one PVS lesion, mechanical dilatation was sufficient. Long-term follow-up after 60 ± 69 months revealed an average restenosis rate of 38%. Restenosis was defined as narrowing >70%. All patients reported clinical improvement of symptoms at follow-up. CONCLUSION: Even in the era of wide circumferential lesions, PVS still occurs. While surgical PV patch plasty represents a valuable treatment option, restenosis remains an issue during follow-up. Nevertheless, surgical repair achieves highly acceptable long-term results for RFA-acquired PVS. Hence, it should be routinely discussed as a therapeutic option in cases with multiple PVS.

Cardiac MRI Texture Analysis of T1 and T2 Maps in Patients with Infarctlike Acute Myocarditis.

Purpose To assess the diagnostic potential of texture analysis applied to T1 and T2 maps obtained with cardiac MRI for the diagnosis of acute infarctlike myocarditis. Materials and Methods This prospective study from August 2012 to May 2015 included 39 participants (overall mean age ± standard deviation, 34.7 years ± 12.2 [range, 18-63 years]; mean age of women, 46.1 years ± 10.8 [range, 24-63 years]; mean age of men, 29.8 years ± 9.2 [range, 18-56 years]) from the Magnetic Resonance Imaging in Myocarditis (MyoRacer) trial with clinical suspicion of acute myocarditis and infarctlike presentation. Participants underwent biventricular endomyocardial biopsy, cardiac catheterization, and cardiac MRI at 1.5 T, in which native T1 and T2 mapping as well as Lake Louise criteria (LLC) were assessed. Texture analysis was applied on T1 and T2 maps by using a freely available software package. Stepwise dimension reduction and texture feature selection was performed for selecting features enabling the diagnosis of myocarditis by using endomyocardial biopsy as the reference standard. Results Endomyocardial biopsy confirmed the diagnosis of acute myocarditis in 26 patients, whereas 13 participants had no signs of acute inflammation. Mean T1 and T2 values and LLC showed a low diagnostic performance, with area under the curve in receiver operating curve analyses as follows: 0.65 (95% confidence interval [CI]: 0.45, 0.85) for T1, 0.67 (95% CI: 0.49, 0.85) for T2, and 0.62 (95% CI: 0.42, 0.79) for LLC. Combining the texture features T2 run-length nonuniformity and gray-level nonuniformity resulted in higher diagnostic performance with an area under the curve of 0.88 (95% CI: 0.73, 1.00) (P < .001) and a sensitivity and specificity of 89% [95% CI: 81%, 93%] and 92% [95% CI: 77%, 93%], respectively. Conclusion Texture analysis of T2 maps shows high sensitivity and specificity for the diagnosis of acute infarctlike myocarditis. © RSNA, 2018 Online supplemental material is available for this article.

App-Based Mental Training to Reduce Atrial Fibrillation-Related Symptoms After Pulmonary Vein Isolation: MENTAL AF Trial.

BACKGROUND: Even after atrial fibrillation (AF) catheter ablation, many patients still experience relevant symptom burden. The objective of the MENTAL AF trial was to determine whether app-based mental training (MT) during the 3 months following pulmonary vein isolation reduces AF-related symptoms. METHODS AND RESULTS: Patients scheduled for pulmonary vein isolation were enrolled and randomized 1:1 to either app-based MT or usual care. Of 174 patients, 76 in the MT and 75 in the usual care group were included in the final analysis. The intervention was delivered by a daily 10-minute app-based MT. The primary outcome was the intergroup difference of the mean AF6 sum score, an AF-specific questionnaire, during the 3-month study period. Secondary outcomes included quality-of-life measures such as the AFEQT (Atrial Fibrillation Effect on Quality of Life). Mean age (SD) was 61 (8.7) years and 61 (41%) were women. The mean AF6 sum score over the study period was 8.9 (6.9) points in the MT group and 12.5 (10.1) in the usual care group (P=0.011). This referred to a reduction in the AF6 sum score compared with baseline of 75% in MT and 52% for usual care (P<0.001). The change in the AFEQT Global Score was 22.6 (16.3) and 15.7 (22.1), respectively; P=0.026. CONCLUSIONS: MENTAL AF showed that app-based MT as an adjunctive treatment tool following pulmonary vein isolation was feasible. App-based MT was found to be superior to standard care in reducing AF-related symptom burden and improving health-related quality of life. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04067427.

Changes in left atrial function in patients undergoing cardioversion for atrial fibrillation: relevance of left atrial strain in heart failure.

BACKGROUND: Left atrial (LA) reservoir strain provides prognostic information in patients with and without heart failure (HF), but might be altered by atrial fibrillation (AF). The aim of the current study was to investigate changes of LA deformation in patients undergoing cardioversion (CV) for first-time diagnosis of AF. METHODS AND RESULTS: We performed 3D-echocardiography and strain analysis before CV (Baseline), after 25 ± 10 days (FU-1) and after 190 ± 20 days (FU-2). LA volumes, reservoir, conduit and active function were measured. In total, 51 patients were included of whom 35 were in SR at FU-1 (12 HF and preserved ejection fraction (HFpEF)), while 16 had ongoing recurrence of AF (9 HFpEF). LA maximum volume was unaffected by cardioversion (Baseline vs. FU-2: 41 ± 11 vs 40 ± 10 ml/m2; p = 0.85). Restored SR led to a significant increase in LA reservoir strain (Baseline vs FU-1: 12.9 ± 6.8 vs 24.6 ± 9.4, p < 0.0001), mediated by restored LA active strain (SR group Baseline vs. FU-1: 0 ± 0 vs. 12.3 ± 5.3%, p < 0.0001), while LA conduit strain remained unchanged (Baseline vs. FU-1: 12.9 ± 6.8 vs 13.1 ± 6.2, p = 0.78). Age-controlled LA active strain remained the only significant predictor of LA reservoir strain on multivariable analysis (ß 1.2, CI 1.04-1.4, p < 0.0001). HFpEF patients exhibited a significant increase in LA active (8.2 ± 4.3 vs 12.2 ± 6.6%, p = 0.004) and reservoir strain (18.3 ± 5.7 vs. 22.8 ± 8.8, p = 0.04) between FU-1 and FU-2, associated with improved LV filling (r = 0.77, p = 0.005). CONCLUSION: Reestablished SR improves LA reservoir strain by restoring LA active strain. Despite prolonged atrial stunning following CV, preserved SR might be of hemodynamic and prognostic benefit in HFpEF.

Deep learning detects heart failure with preserved ejection fraction using a baseline electrocardiogram.

Aims: Heart failure with preserved ejection fraction (HFpEF) is a rapidly growing global health problem. To date, diagnosis of HFpEF is based on clinical, invasive, and laboratory examinations. Electrocardiographic findings may vary, and there are no known typical ECG features for HFpEF. Methods and results: This study included two patient cohorts. In the derivation cohort, we included n = 1884 patients who presented with exertional dyspnoea or equivalent and preserved ejection fraction (≥50%) and clinical suspicion for coronary artery disease. The ECGs were divided in segments, yielding a total of 77 558 samples. We trained a convolutional neural network (CNN) to classify HFpEF and control patients according to European Society of Cardiology (ESC) criteria. An external group of 203 volunteers in a prospective heart failure screening programme served as a validation cohort of the CNN. The external validation of the CNN yielded an area under the curve of 0.80 [95% confidence interval (CI) 0.74-0.86] for detection of HFpEF according to ESC criteria, with a sensitivity of 0.99 (95% CI 0.98-0.99) and a specificity of 0.60 (95% CI 0.56-0.64), with a positive predictive value of 0.68 (95%CI 0.64-0.72) and a negative predictive value of 0.98 (95% CI 0.95-0.99). Conclusion: In this study, we report the first deep learning-enabled CNN for identifying patients with HFpEF according to ESC criteria including NT-proBNP measurements in the diagnostic algorithm among patients at risk. The suitability of the CNN was validated on an external validation cohort of patients at risk for developing heart failure, showing a convincing screening performance.

Health Status After Transcatheter Tricuspid Valve Repair in Patients With Functional Tricuspid Regurgitation.

OBJECTIVES: The aim of this study was to investigate changes in quality of life (QoL) after transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR). BACKGROUND: TTVR provides feasible and durable efficacy in reducing TR, but its clinical benefits on QoL still remain unclear. METHODS: In 115 subjects undergoing TTVR for severe functional TR, QoL was evaluated using the 36-Item Short Form Health Survey (SF-36) and the Minnesota Living With Heart Failure Questionnaire (MLHFQ). All-cause mortality, heart failure (HF) rehospitalization, and a composite endpoint of all-cause mortality, HF rehospitalization, and repeat TTVR were recorded as clinical events. RESULTS: Successful device implantation was achieved in 110 patients (96%). Moderate or less TR at discharge was achieved in 95 patients (83%). Mean SF-36 physical component summary (PCS) score improved from 34 ± 9 to 37 ± 9 points (+3 points; 95% CI: 1-5 points; P = 0.001), mean SF-36 mental component summary score improved from 49 ± 9 to 51 ± 10 points (+2 points; 95% CI: 0-4 points; P = 0.017), and mean MLHFQ score decreased from 29 ± 14 to 20 ± 15 points (-8 points; 95% CI: -11 to -5 points; P < 0.001). Baseline PCS, moderate or less TR at discharge, and baseline massive or torrential TR were associated with 1-month change in PCS score (P < 0.05). Change in PCS score after 1 month predicted HF rehospitalization after TTVR (adjusted HR: 0.74 [95% CI: 0.60-0.92] per 5-point increase in PCS score; P = 0.008). CONCLUSIONS: This study demonstrates that TTVR provides improvement in QoL in patients with relevant TR. TR reduction to a moderate or less grade was associated with improvement of SF-36 and MLHFQ scores. Further, global QoL was associated with clinical outcomes and might serve as a future outcome surrogate following TTVR.

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

BACKGROUND: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. METHODS: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. RESULTS: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). CONCLUSIONS: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.

BACKGROUND: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. METHODS: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively. RESULTS: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. CONCLUSIONS: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry.

OBJECTIVES: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. BACKGROUND: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. METHODS: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). CONCLUSIONS: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

Incidence and characteristics of ventricular tachycardia in patients after percutaneous coronary revascularization of chronic total occlusions.

OBJECTIVES: This study sought to investigate the prevalence of ventricular tachycardia after percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). BACKGROUND: PCI of a CTO is associated with improvement of the left ventricular ejection fraction and possibly associated with reduced mortality. However, benefits of CTO-PCI must be weighed against a higher risk of procedure-related complications. The incidence of new-onset ventricular tachycardia after a successful CTO-PCI has not been investigated so far. In this retrospective registry we seek to describe characteristics and predictors of occurrence of post-procedural ventricular tachycardias. METHODS AND RESULTS: Between 2010 and 2015, 485 patients underwent successful CTO-PCI at Heart Center Leipzig. Of them, 342 had complete follow-up and were further analyzed. Ventricular tachycardias were detected in 9 (2.6%) patients. All of them were monomorphic ventricular tachycardias occurring in median 1 day (interquartile range [IQR] 0.25-4.75 days) after PCI and caused prolongation of the hospital stay. Patients with ventricular tachycardia were older, had worse left ventricular ejection fraction (mean 33.1%, SD 5.9%) and more frequently a CTO of an infarct-related artery. The target vessel was not associated with the occurrence of ventricular arrhythmias. In multivariable analysis, only impaired left ventricular systolic function was an independent predictor for procedure-related ventricular tachycardia. Mortality rates were not different between patients with or without ventricular tachycardia. CONCLUSION: Ventricular tachycardia can occur early after CTO-PCI as possible reperfusion arrhythmia and poorer left ventricular ejection fraction is the only independent predictor for onset. Although the occurrence of ventricular tachycardia after CTO-PCI seems not to influence mortality, awareness of this possible complication and longer monitoring may be recommended.