A Novel Quadripolar Active Fixation Left-Ventricular Pacing Lead for Cardiac Resynchronization Therapy (original) (raw)
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Circulation journal, 2016
Methods Study Population From January 2010 to January 2012, 43 consecutive patients (mean age 69±9 years; 37 male), referred to our Center for CRT, were prospectively enrolled and randomized using a computergenerated table of random numbers. Of them, 23 patients (mean age 67±11 years; 21 male) were implanted with a quadripolar LV lead (group 1) and 20 patients (mean age 71±6 years; 16 male) with a bipolar LV lead (group 2). Patients with a preexisting pacemaker or ICD device were excluded. Indications for CRT implantation were based on the European Society of Cardiology guidelines for HF recommendations. 1 In particular, all patients had an ejection fraction (EF) <35% and QRS duration ≥130 ms with left bundle branch block (LBBB) morphology. ardiac resynchronization therapy (CRT) is a wellestablished therapy for treatment of heart failure (HF) with severely impaired left ventricular (LV) systolic function and evidence of ventricular dyssynchrony. 1,2 Although advances in technology and clinical indications have increased the success rate, 3,4 a sizable proportion of patients fail to show clinical or echocardiographic response to this treatment. 5,6 Response to biventricular pacing may vary according to the site of pacing; in particular, the mid-ventricular and basal portions of the lateral LV wall were recently associated with the best response. 7,8 Recently, quadripolar LV leads have been designed in order to provide more options for LV pacing. 9-15 This new lead integrates 4 pacing electrodes that allow a higher number of pacing configurations in device programming as compared with traditional bipolar LV leads. Recent studies suggest that CRT with quadripolar LV lead is associated with a higher implantation success rate and low rates of dislocation and phrenic nerve stimulation (PNS). 10,12,14 In this study, we tested if choosing the pacing configuration associated with C
Scientific Reports, 2018
We evaluated the performance of 3 different left ventricular leads (LV) for resynchronization therapy: bipolar (BL), quadripolar (QL) and active fixation leads (AFL). We enrolled 290 consecutive CRTD candidates implanted with BL (n = 136) or QL (n = 97) or AFL (n = 57). Over a minimum 10 months follow-up, we assessed: (a) composite technical endpoint (TE) (phrenic nerve stimulation at 8 V@0.4 ms, safety margin between myocardial and phrenic threshold <2V, LV dislodgement and failure to achieve the target pacing site), (b) composite clinical endpoint (CE) (death, hospitalization for heart failure, heart transplantation, lead extraction for infection), (c) reverse remodeling (RR) (reduction of end systolic volume >15%). Baseline characteristics of the 3 groups were similar. At follow-up the incidence of TE was 36.3%, 14.3% and 19.9% in BL, AFL and QL, respectively (p < 0.01). Moreover, the incidence of RR was 56%, 64% and 68% in BL, AFL and QL respectively (p = 0.02). There were no significant differences in CE (p = 0.380). On a multivariable analysis, "non-BL leads" was the single predictor of an improved clinical outcome. QL and AFL are superior to conventional BL by enhancing pacing of the target site: AFL through prevention of lead dislodgement while QL through improved management of phrenic nerve stimulation. Cardiac resynchronization (CRT) is a proven heart failure therapy, but a minority of patients (pts) have no clinical benefit 1. The lack of improvement is multi-faceted, owing both to pts selection and technical CRT issues. Phrenic nerve stimulation (PNS), high myocardial threshold (HMT), left ventricular lead dislodgement (LD) and failure to achieve the target pacing site are the most frequent technical issues 1,2 , that were aimed at by the introduction of new left ventricular leads such as the quadripolar (QL) and the bipolar active fixation leads (AFL) 3-6. This is the first study comparing 3 different LV lead platforms for CRT with defibrillator: bipolar passive fixation lead (BL), QL and AFL. The purpose was to evaluate at long term the performance of these 3 different LV leads from both the technical and clinical outcome standpoint. Methods This was a single center observational study carried out on pts consecutively implanted with a CRT with defibrillator (D) and 3 different LV lead platforms: BL, QL and AFL. The study of LV performance was approved by the local Ethic Committee of the University Hospital S.Orsola-Malpighi (Bologna, Italy) and complies with the principles outlined in the Declaration of Helsinki. Pts provided informed consent for data collection and analysis. All the 4 implanting physicians have ≥10 years experience in CRT implantation, hence a learning-curve effect was excluded. The study enrolled all the pts implanted with CRT-D
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2011
Problems with implanting a left ventricular (LV) lead during cardiac resynchronization therapy (CRT) procedures are not uncommon and may occur for a variety of reasons including phrenic nerve stimulation (PNS) and high capture thresholds. We aimed to perform successful CRT in patients with previous LV lead problems using the multiple pacing configurations available with the St Jude Quartet model 1458Q quadripolar LV lead to overcome PNS or high capture thresholds.
Heart rhythm : the official journal of the Heart Rhythm Society, 2014
The Medtronic Attain Performa™ Quadripolar Leads provide 16 pacing vectors with steroid on every electrode. This includes a short Bipolar configuration between the middle two electrodes. A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries. Cardiac resynchronization therapy defibrillator (CRT-D) candidates were enrolled; (mean age 68 years and 71% male). All implanted subjects were followed at 1, 3, and 6 months post-implant. Pacing capture thresholds (PCT) values were measured at each visit. Adverse events (AEs) were reported upon occurrence. Of 1,124 subjects in whom a left ventricular (LV) lead was attempted, 1097 (97.6%) were successfully implanted with an Attain Performa lead. Thirty-six (36) LV lead-related complications were reported (6 month LV lead-related complication free survival rate was 96.9%). Phrenic nerve stimulation (PNS) occurred in 81 subjects (7.2%) with only 3 (0.3%) requiring surgical interve...
Pacing and Clinical Electrophysiology, 2014
Background: The objective of the present study was to evaluate the usefulness of a left ventricle (LV) quadripolar lead in improving the hemodynamic response to cardiac resynchronization therapy (CRT). Methods and Results: We included 27 consecutive patients implanted with a CRT device with an LV quadripolar lead. Hemodynamic parameters were evaluated at 3-month follow-up by using impedance cardiography. We assessed the highest cardiac output and the highest stroke volume (SV) obtained after atrioventricular and interventricular optimization with pacing from each of the four electrodes of the LV lead. Each patient was evaluated according to three different pacing configurations: unipolar-simulated, bipolar, and quadripolar. Biventricular pacing improved hemodynamics in comparison to the nonpaced measurements: cardiac index (CI): 2.69 L/min/m 2 versus 2.17 L/min/m 2 (P = 0.001). The hemodynamic response was highest in the quadripolar in comparison to unipolar-simulated and bipolar configurations, with an increase of 29%, 23%, and 27%, respectively, in relation to the reference CI and with an increase of 22%, 11%, and 18%, respectively, in relation to the reference indexed SV (P < 0.05, for the comparison between unipolar-simulated and quadripolar configurations). Twelve patients (44%) showed the best hemodynamic response by pacing from any of the two distal electrodes and 15 patients (56%) by pacing from the two proximal electrodes. Finally, CRT responder rates were higher in quadripolar versus bipolar and unipolar-simulated configurations: 90%, 85%, and 75%, respectively. Conclusions: The quadripolar LV lead was associated with a better hemodynamic response and higher CRT responder rates when compared with unipolar-simulated and bipolar LV leads. (PACE 2015; 38:326-333) cardiac resynchronization, quadripolar lead, phrenic, responder Background Cardiac resynchronization therapy (CRT) is a well-accepted therapy for patients with heart failure (HF) symptoms, left ventricular (LV) systolic dysfunction, and QRS interval prolongation. Biventricular pacing is associated with an improved quality of life, increased functional capacity, reduction in hospitalization for HF, and increased survival. 1,2 Unfortunately, a significant proportion of patients (up to 30-35%) do not respond to CRT therapy (nonresponders), adversely affecting the utility and cost effectiveness of this form of device therapy for HF. 3 There are many
Initial single-center experience of a quadripolar pacing lead for cardiac resynchronization therapy
Pacing and clinical electrophysiology : PACE, 2011
Background: The Quartet model 1458Q (St. Jude Medical, Sylmar, CA, USA) lead is a quadripolar left ventricular (LV) lead with pace/sense capability from four electrodes (tip and three rings). The lead is capable of pacing in 10 different configurations rather than the three that are available in conventional bipolar pacing leads. We describe a single-center initial experience of the use of this lead in patients undergoing cardiac resynchronization therapy (CRT).Methods: Twenty-eight patients for a CRT with cardiac defibrillator were implanted between October 2009 and May 2010 with a Quartet lead. Lead position, pacing parameters, stability, complications, and presence of phrenic nerve stimulation (PNS) data were collected at implant and predischarge. Follow-up data were collected at 15 ± 8 weeks for all patients.Results: A Quartet lead was successfully implanted in 96% (27/28) of patients (age 61 ± 15 years; 82% male; ischemic etiology 50%; mean left ventricular [LV] ejection fraction 25 ± 7%; left bundle branch block 68%). PNS was seen at implant in 11 patients (41%) with at least one vector. In eight of these cases (72%), the need for lead repositioning was averted by programming LV pacing utilizing the additional vectors available with the Quartet lead.Conclusion: These initial data suggest that pacing with the Quartet lead is associated with a high implant success rate and stable pacing parameters acutely and at short-term follow-up. The 10 LV pacing vectors available with this lead may allow PNS and capture threshold problems to be easily overcome. (PACE 2011; 34:484–489)
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2015
To compare the effects on left ventricular (LV) function of right ventricular (RV) septal pacing vs. cardiac resynchronization therapy (CRT) in patients with an indication for the latter. Cardiac resynchronization therapy is an effective therapy in patients with drug-refractory heart failure. Despite advances in implantation techniques, LV lead placement can be impossible in up to 10% of cases. We, therefore, assessed the effects of RV septal pacing from mid septum (RVmIVS) and outflow tract (RVOT) on cardiac performance, in comparison with CRT. Twenty-two patients scheduled for CRT underwent dual-chamber temporary pacing. The ventricular lead was placed at the RV apex (RVA), RVmIVS, and RVOT in random order. Comprehensive echocardiography was performed in a baseline AAI mode and then at each RV position in dual chamber pacemaker function (D pacing, D sensing, D dual responses) mode and repeated on the next day following CRT implantation. Right ventricular apex pacing did not change...