TUGENDHAT: a pilot randomized study on effects of biventricular pacing in patients with bradycardia pacing indication and normal systolic function on heart failure, atrial fibrillation and quality of life (results of 12 month follow-up)

Abstract

Abstract:Background: Since the late 1990s, a growing number of clinical studies have indicated that long-term permanent right ventricular (RV) apical pacing will induce severe complications such as development of heart failure, increased burden of atrial fi brillation leading to decreased quality of life. Aim of the study: To investigate whether cardiac resynchronization therapy (CRT) using biventricular (BiV) pacing can prevent the development of left ventricular (LV) dysfunction, LV remodelling, worsening of the clinical status and quality of life in chronically RV paced patients with normal LV ejection fraction (EF). Methods and results:A total of 127 patients with Class I indication for permanent cardiac pacing and without established indication for CRT were subjected to 6 months of RV and BiV pacing in a patient-blinded, randomized crossover trial. Treatment effects of BiV pacing were evaluated for LV function, LV remodelling and clinical status. Conclusion: BiV pacing, compared to RV pacing, did not change LV function and quality of life in patients with the absence of LV dysfunction or remodelling, standard bradycardia pacing indications in a pilot phase (12-month follow-up) of the TUGENDHAT trial. The fi nal report will be published after 60-month follow-up termination (Tab. 5, Fig. 3, Ref. 30). Full Text in PDF www.elis.sk. Key words: BiV and RV pacing, LV remodelling, heart failure, atrial fi brillation, quality of life. Results of several trials have supported the fact that right ventricular (RV) apical pacing might lead to adverse clinical outcomes in patients with standard pacing indications. Nevertheless, RV apical pacing continues to be practiced by many physicians because of its easy accessibility and relative stability over time (1, 2). The optimal mode and site of pacing remain undefi ned.The detrimental effect of RV pacing is probably most important in patients with pre-existing left ventricular (LV) dysfunction and may lead to worsening of heart failure (3, 4). In RV pacing, the sequence of electrical activation resembles the activation pattern in left bundle branch block (LBBB). This asynchronous electrical pattern is accompanied by abnormal dyssynchronous mechanical interactions within the LV (5). Experimental data suggested that biventricular (BiV) pacing might preserve myocardial performance better than RV apical pacing in patients with atrioventricular (AV) block and normal systolic function (6). The underlying mechanism may be a signifi cant reduction in LV systolic dyssynchrony, as shown by Cojoc et al (7). In the majority of patients with severe LV dysfunction and severe clinical heart failure associated with either LBBB-or RV pacing-induced dyssynchrony, BiV pacing improves clinical status, reduces mortality and morbidity, reduces heart failure (HF) hospitalizations, reverses LV remodelling and improves LV function (8, 9). Therefore, BiV pacing is nowadays recommended in patients with ventricular dyssynchrony (QRS > 120 ms), severe LV dysfunction [LV ejection fraction (LVEF) < 0.35] ...

Network meta‐analysis of His bundle, biventricular, or right ventricular pacing as a primary strategy for advanced atrioventricular conduction disease with normal or mildly reduced ejection fraction

“…TUGENDHAT trial 24 : pilot study, patient‐blinded, randomized crossover trial aimed to investigate if BiV pacing could prevent left ventricular dysfunction, remodeling, worsening of clinical status, and quality of life compared with RV pacing in 6 months for patients with class I indication for permanent cardiac pacing and without established indication for BiV pacing. This study was published as an abstract, and failed to present baseline characteristics, including baseline EF, as well as no report of outcomes of interest, including death, HFHs, QRS duration, and echocardiographic data.…”

Modalities of ventricular pacing for cardiac resynchronization therapy in patients with heart failure: a meta-analysis and systematic review

“…Of these, 4 studies were not RCTs, 4 studies did not report outcomes of interest, 8 studies had different interventions, and 2 studies were excluded for being a study protocol ( Figure 1 ). Of the 14 RCTs which were included in the final analysis, six were cross-over trials [ 19 , 21 , 28 – 31 ]. Three RCTs compared the effect of TriV to that of BiV [ 23 , 29 , 30 ], and the sample size ranged from 18 to 306 patients.…”

“…Although a number of studies demonstrated that BiV pacing was associated with superior outcomes compared to conventional CRT [ 32 ], LUV pacing [ 33 ], and RUV pacing in patients without advanced HF [ 34 ], other studies reported no significant difference in improvement in NYHA scores and reverse remodeling between patients who received BiV pacing and those who received LUV pacing [ 20 , 21 ], as well as between those who received BiV pacing and those who received RUV pacing [ 28 ]. Additionally, patients who failed to respond to BiV pacing responded to LUV pacing [ 19 ].…”

Contact-Force Guided Pulmonary Vein Isolation does not Improve Success Rate in Persistent Atrial Fibrillation Patients and Severe Left Atrial Enlargement: A 12-month Follow-Up Study

“…CF technology allows a real-time assessment of the catheter-tissue CF. Low CF during PV isolation is a predictor of acute and chronic PV reconnections, and is associated with an increased risk of AF recurrence [7][8][9][10] . In addition, ablation procedures under CF guidance improve the lower recurrence rate of the PV isolation [11] .…”

“…Contact-force (CF) catheters provide information to the operator to assess the proximity of the catheter to the endocardium. Low CF during pulmonary vein isolation (PVI) has been shown to be a predictor of acute and chronic PV reconnections, and is associated with an increased risk of AF recurrence [7][8][9][10] . CF has been shown to improve the durability of the PV isolation and empower the efficacy of catheter ablation [11] .…”