The purpose of our study was to evaluate the feasibility and efficacy of cardiac resynchronization therapy (CRT) via left bundle branch pacing (LBBP-CRT) compared with optimized biventricular pacing ...(BVP) with adaptive algorithm (BVP-aCRT) in heart failure with reduced left ventricular ejection fraction ≤35% (HFrEF) and left bundle branch block (LBBB).
One hundred patients with HFrEF and LBBB undergoing CRT were prospectively enrolled in a non-randomized fashion and divided into two groups (LBBP-CRT, n = 49; BVP-aCRT, n = 51) in four centres. Implant characteristics and echocardiographic parameters were accessed at baseline and during 6-month and 1-year follow-up. The success rate for LBBP-CRT and BVP-aCRT was 98.00% and 91.07%. Fused LBBP had the greatest reduced QRS duration compared to BVP-aCRT (126.54 ± 11.67 vs. 102.61 ± 9.66 ms, P < 0.001). Higher absolute left ventricular ejection fraction (LVEF) and △LVEF was also achieved in LBBP-CRT than BVP-aCRT at 6-month (47.58 ± 12.02% vs. 41.24 ± 10.56%, P = 0.008; 18.52 ± 13.19% vs. 12.89 ± 9.73%, P = 0.020) and 1-year follow-up (49.10 ± 10.43% vs. 43.62 ± 11.33%, P = 0.021; 20.90 ± 11.80% vs. 15.20 ± 9.98%, P = 0.015, P = 0.015). There was no significant difference in response rate between two groups while higher super-response rate was observed in LBBP-CRT as compared to BVP-aCRT at 6 months (53.06% vs. 36.59%, P = 0.016) and 12 months (61.22% vs. 39.22%, P = 0.028) during follow-up. The pacing threshold was lower in LBBP-CRT at implant and during 1-year follow-up (both P < 0.001). Procedure-related complications and adverse clinical outcomes including heart failure hospitalization and mortality were not significantly different in two groups.
The feasibility and efficacy of LBBP-CRT demonstrated better electromechanical resynchronization and higher clinical and echocardiographic response, especially higher super-response than BVP-aCRT in HFrEF with LBBB.
Right ventricular (RV) pacing may worsen left ventricular cardiomyopathy in patients with reduced left ventricular ejection fraction (LVEF) and advanced atrioventricular block.
The objectives of this ...study were to calculate incidence and identify predictors of RV pacing-induced cardiomyopathy (PICM) in complete heart block (CHB) with preserved LVEF and to describe outcomes of subsequent cardiac resynchronization therapy (CRT) upgrade.
An analysis of consecutive patients receiving permanent pacemaker (PPM) from 2000 to 2014 for CHB with LVEF >50% was performed. PICM was defined as CRT upgrade or post-PPM LVEF ≤40%. PICM association was determined via multivariable regression analysis. CRT response was defined by LVEF increase ≥10% or left ventricular end-systolic volume decrease ≥15%.
Of the 823 study patients, 101 (12.3%) developed PICM over the mean follow-up of 4.3 ± 3.9 years, with post-PPM LVEF being 33.7% ± 7.4% in patients with PICM vs 57.6% ± 6.1% in patients without PICM (P < .001). In multivariable analysis, lower pre-PPM LVEF (hazard ratio HR 1.047 per 1% LVEF decrease; 95% confidence interval CI 1.002-1.087; P = .042) and RV pacing % both as a continuous (HR 1.011 per 1% RV pacing; 95% CI 1.002-1.02; P = .021) and as a categorical (<20% or ≥20% RV pacing) (HR 6.76; 95% CI 2.08-22.0; P = .002) variable were independently associated with PICM. Only 29 patients with PICM (28.7%) received CRT upgrade despite an 84% responder rate (LVEF increase 18.5% ± 8.1% and left ventricular end-systolic volume decrease 45.1% ± 15.0% in responders). CRT upgrade was associated with greater post-PPM LVEF decrease, lower post-PPM LVEF, and post-PPM LVEF ≤35% (P = .006, P = .004, and P = .004, respectively).
PICM is not uncommon in patients receiving PPM for CHB with preserved LVEF and is strongly associated with RV pacing burden >20%. CRT response rate is high in PICM, but is perhaps underutilized.
This study aims to investigate the long-term occurrence of the composite endpoint of heart failure (HF) hospitalization or all-cause death (primary endpoint) in patients randomized to cardiac ...resynchronization therapy (CRT) using individualized multimodality imaging-guided left ventricular (LV) lead placement compared with a routine fluoroscopic approach. Furthermore, this study aims to evaluate whether inter-lead electrical delay (IED) is associated with improved response rate of this endpoint.
We reviewed follow-up data until November 2020 for all 182 patients included in the ImagingCRT trial for the occurrence of HF hospitalization and all-cause death. During median (inter-quartile range) time to primary endpoint/censuring of 6.7 (3.3-7.9) years, the rate of the primary endpoint was 60% (n = 53) in the imaging group compared with 52% (n = 48) in the control group hazard ratio (HR) 1.22, 95% confidence interval (CI) 0.83-1.81, P = 0.31. Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32). The risk of the primary endpoint was significantly reduced among those with IED ≥100 ms when compared with those with IED <100 ms (HR 0.62, 95% CI 0.39-0.98, P = 0.04).
In this study, an individualized multimodality imaging-guided strategy targeting LV lead placement towards the latest mechanically activated non-scarred myocardial segment during CRT implantation did not reduce HF hospitalization or all-cause death when compared with routine LV lead placement during long-term follow-up. Targeting the latest electrical activation should be studied as an alternative individualized strategy for optimizing LV lead placement in CRT recipients.
Background
The rate of left ventricular (LV) lead displacement after cardiac resynchronization therapy (CRT) remains high despite improvements in lead technology. In 2017, a novel quadripolar lead ...with active fixation technology became available in the UK.
Methods
This was a retrospective, observational study analyzing device complications in 476 consecutive patients undergoing successful first‐time implantation of a CRT device at a tertiary center from 2017 to 2020.
Results
Both active (n = 135) and passive fixation (n = 341) quadripolar leads had similar success rates for implantation (99.3% vs. 98.8%, p = 1.00), although the pacing threshold (0.89 0.60–1.25 vs. 1.00 0.70–1.60 V, p = .01) and lead impedance (632 552–794 vs. 730 636–862 Ohms, p < .0001) were significantly lower for the active fixation lead. Patients receiving an active fixation lead had a reduced incidence of lead displacement at 6 months (0.74% vs. 4.69%, p = .036). There was no significant difference in the rate of right atrial (RA) and right ventricular (RV) lead displacement between the two groups (RA: 1.48% vs. 1.17%, p = .68; RV: 2.22% vs. 1.76%, p = .72). Reprogramming the LV lead after displacement was unsuccessful in most cases (successful reprogramming: Active fix = 0/1, Passive fix = 1/16) therefore nearly all patients required a repeat procedure. As a result, the rate of intervention within 6 months for lead displacement was significantly lower when patients were implanted with the active fixation lead (0.74% vs. 4.40%, p = .049).
Conclusion
The novel active fixation lead in our study has a lower incidence of lead displacement and re‐intervention compared to conventional quadripolar leads for CRT.
The population of patients with heart failure continues to grow, which introduced significant challenges in clinical practice related to the management of cardiac arrhythmia and advanced heart ...failure syndromes. Device therapy has increasingly become essential in the management of life-threatening arrhythmia and clinical heart failure in this population. This review will discuss the use of cardiac implantable electronic devices in heart failure with primary focus on sudden cardiac death prevention and cardiac resynchronization, including published evidence and evolving technologies.
Abstract
Aims
We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators.
Methods and ...results
The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 95% confidence interval (CI): 0.83–0.95 with 2.73 odds ratio (CI 1.98–3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7–82.1%), median alerting time 42 days (interquartile range 21–89), and false (or unexplained) alert rate 0.69 (CI 0.64–0.74) or 0.63 (CI 0.58–0.68) per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year.
Conclusion
With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.
Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy ...to an LV electrode.
The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience.
Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months.
The WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month follow-up. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated ≥1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume improved from 28.3% ± 6.7% to 33.5% ± 6.9% (P < .001), 134.9 ± 51.3 mL to 111.1 ± 40.3 mL (P = .0004), and 185.4 ± 58.8 mL to 164.9 ± 50.6 mL (P = .0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection.
We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted.
Abstract Background Remote monitoring (RM) technology embedded within cardiac rhythm devices permits continuous monitoring, which may result in improved patient outcomes. Objectives This study used ...“big data” to assess whether RM is associated with improved survival and whether this is influenced by the type of cardiac device and/or its degree of use. Methods We studied 269,471 consecutive U.S. patients implanted between 2008 and 2011 with pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) with pacing capability (CRT-P)/defibrillation capability (CRT-D) with wireless RM. We analyzed weekly use and all-cause survival for each device type by the percentage of time in RM (%TRM) stratified by age. Socioeconomic influences on %TRM were assessed using 8 census variables from 2012. Results The group had implanted PMs (n = 115,076; 43%), ICDs (n = 85,014; 32%), CRT-D (n = 61,475; 23%), and CRT-P (n = 7,906; 3%). When considered together, 127,706 patients (47%) used RM, of whom 67,920 (53%) had ≥75%TRM (high %TRM) and 59,786 (47%) <75%TRM (low %TRM); 141,765 (53%) never used RM (RM None). RM use was not affected by age or sex, but demonstrated wide geographic and socioeconomic variability. Survival was better in high %TRM versus RM None (hazard ratio HR: 2.10; p < 0.001), in high %TRM versus low %TRM (HR: 1.32; p < 0.001), and also in low %TRM versus RM None (HR: 1.58; p < 0.001). The same relationship was observed when assessed by individual device type. Conclusions RM is associated with improved survival, irrespective of device type (including PMs), but demonstrates a graded relationship with the level of adherence. The results support the increased application of RM to improve patient outcomes.
Lower Mortality and Eliminated PNS Associated with Quadripolar Leads
Introduction
Cardiac resynchronization therapy (CRT) using quadripolar left ventricular (LV) leads provides more pacing vectors ...compared to bipolar leads. This may avoid phrenic nerve stimulation (PNS) and allow optimal lead placement to maximize biventricular pacing. However, a long‐term improvement in patient outcome has yet to be demonstrated.
Methods
A total of 721 consecutive patients with conventional CRTD criteria implanted with quadripolar (n = 357) or bipolar (n = 364) LV leads were enrolled into a registry at 3 UK centers. Lead performance and mortality was analyzed over a 5‐year period.
Results
Patients receiving a quadripolar lead were of similar age and sex to those receiving a bipolar lead, although a lower proportion had ischemic heart disease (62.6% vs. 54.1%, P = 0.02). Both groups had similar rates of procedural success, although lead threshold, impedance, and procedural radiation dose were significantly lower in those receiving a quadripolar lead. PNS was more common in those with quadripolar leads (16.0% vs. 11.6%, P = 0.08), but was eliminated by switching pacing vector in all cases compared with 60% in the bipolar group (P < 0.001). Furthermore, LV lead displacement (1.7% vs. 4.6%, P = 0.03) and repositioning (2.0% vs. 5.2%, P = 0.03) occurred significantly less often in those with a quadripolar lead. All‐cause mortality was also significantly lower in the quadripolar compared to bipolar lead group in univariate and multivariate analysis (13.2% vs. 22.5%, P < 0.001).
Conclusions
In a large, multicenter experience, the use of quadripolar LV leads for CRT was associated with elimination of PNS and lower overall mortality. This has important implications for LV pacing lead choice.