Left Ventricular Threshold Research Articles

Effect of Li's catheter in the cardiac resynchronization therapy implantation

Objective: To evaluate the effect of Li's catheter in cardiac resynchronization therapy (CRT) implantation. Methods: This study was a retrospective cohort study. Patients with indications for CRT implantation who visited the Department of Cardiology, Peking University People's Hospital from January 1, 2016 to January 1, 2022 were enrolled. Patients were divided into Li's catheter group (CRT implantation with Li's catheter) and control group (CRT implantation with the traditional method). The general clinical data of the patients were obtained through the electronic medical record system. Li's catheter is a new type of coronary sinus angiography balloon catheter independently developed by Dr. Li Xuebin (patent number: 201320413174.1). The primary outcome was the success rate of CRT device implantation, and the secondary outcomes included efficacy and safety parameters. Efficacy indicators included operation time, coronary sinus angiography time, left ventricular lead implantation time, X-ray exposure time, left ventricular lead threshold, and diaphragm stimulation. Safety outcomes included incidence of coronary sinus dissection, cardiac tamponade, and pericardial effusion. Results: A total of 170 patients were enrolled in this study, including 90 in Li's catheter group and 80 in control group. Age, male proportion of patients, proportion of patients with ischemic cardiomyopathy, hypertension, diabetes mellitus, chronic renal insufficiency, New York Heart Association (NYHA) functional classification, left ventricular ejection fraction, left ventricular end-diastolic diameter, proportion of left bundle branch block, and preoperative QRS wave width were similar between the two groups (all P>0.05). In Li's catheter group, 34 cases (37.8%) implanted with CRT defibrillators, and 28 cases (35.0%) implanted with CRT defibrillators in control group, the difference was not statistically significant (P=0.710). The success rate of CRT device implantation in Li's catheter group was 100% (90/90), which was significantly higher than that in control group (93.8%, 75/80, P=0.023).The operation time was 57.0 (52.0, 62.3) minutes, the time to complete coronary sinus angiography was 8.0 (6.0, 9.0) minutes, and the time of left ventricular electrode implantation was 8.0 (7.0, 9.0) minutes in Li's catheter group, and was 91.3 (86.3, 97.0), 18.0 (16.0, 20.0), 25.0 (22.0, 27.7) minutes respectively in control group, all significantly shorter in Li's catheter group (all P<0.05). The exposure time of X-ray was 15.0 (14.0, 17.0) minutes in Li's catheter group, which was also significantly shorter than that in control group (32.5 (29.0, 36.0) minutes, P<0.001). There was no coronary sinus dissection and cardiac tamponade in Li's catheter group, and 1 patient (1.1%) had diaphragmatic stimulation in Li's catheter group. In control group, 6 patients (6.7%) had coronary sinus dissection, and 1 patient (1.1%) developed pericardial effusion, and 3 patients (3.3%) had diaphragmatic stimulation. The incidence of coronary sinus dissection in Li's catheter group was significantly lower than that in control group (P=0.011). The postoperative left ventricular thresholds in Li's catheter group and control group were similar (1.80 (1.60, 2.38) V/0.5 ms vs. 1.80 (1.60, 2.40) V/0.5 ms, P=0.120). Conclusions: Use of Li's catheter is associated with higher success rate of CRT implantation, short time of coronary sinus angiography and left ventricular electrode implantation, reduction of intraoperative X-ray exposure, and lower incidence of coronary vein dissection in this patient cohort.

Long-term performance of left ventricular leads in cardiac resynchronisation therapy.

Cardiac resynchronisation therapy (CRT) confers symptomatic and survival benefits in chronic heart failure with reduced ejection fraction (HFrEF). There remains a paucity of data on long-term performance of left ventricular (LV) leads, particularly with newer quadripolar lead designs. This single-centre study utilised an electronic, outpatient HFrEF database to identify CRT recipients (2008-2014). The primary endpoint was temporal trend in LV pacing thresholds during follow-up. Secondary outcomes were complications relating to acute or chronic lead failure and device-related infections. Two hundred eighty patients were included, with mean (±SD) age of 74.2 years (±9.0) and median follow-up of 7.6 years (interquartile range 4-9). Mean LV threshold was 1.37 V (±0.73) at implant and remained stable over the study period. No differences were observed based upon lead manufacturer. Compared to non-quadripolar leads (n=216), those of quadripolar designs (n=64) had a lower threshold at 6 months (1.20 vs 1.37 V; P=.04) and at the end of the study period (1.32 vs 1.46 V; P=.04). Patients with HFrEF of ischaemic aetiology had higher thresholds at implant (1.46 vs 1.34 V; P=.05), and this persisted until the end of follow-up (1.49 vs 1.34 V; P=.03). There was low incidence of acute (0.71%; 2/280) and chronic lead failure (1.79%; 5/280), with four cases (1.43%) of device infection. LV leads in the context of CRT have excellent chronic stability and low rates of adverse events. Those with newer quadripolar lead designs have lower thresholds at initial follow-up and in the longer term.

Left ventricle automatic pacing threshold management in CRT systems: A comprehensive review.

Modern cardiac resynchronization therapy (CRT) device-based threshold detection enables capture management and voltage output adjusting to combine consistent left ventricular (LV) pacing with acceptable battery drainage. The current technologies available for LV capture automatic confirmation in most cases require the evoked response, as well as "LV pace to right ventricular sense" algorithms.The LV pacing percentage counter may overestimate the CRT delivery which may be reduced due to pacing inhibition (by sensed LV activation) or inadequate capture due to subthreshold current or pacing into refractory tissue. Moreover, the LV threshold at implant and its behavior over time (as a marker of electrical viability) and the ineffective CRT issues (subthreshold stimulation or concealed loss of capture) are discussed.The purpose of the present review is to explore these new challenges regarding LV pacing automatic management.

A Novel Quadripolar Active Fixation Left-Ventricular Pacing Lead for CardiacResynchronization Therapy: Initial United Kingdom Experience.

This study sought to assess immediate and short-term performance of the Medtronic Attain Stability Quadripolar 4798 lead (Medtronic, Dublin, Ireland). Cardiac resynchronization therapy (CRT) is an established treatment for appropriately selected patients with left ventricular (LV) systolic dysfunction. The most common reason for failure to implant a lead is the lack of a suitable epicardial vein, due either to an absent vessel in the target site, an unacceptably high threshold, lead instability, phrenic nerve stimulation, or a combination of reasons. In August 2017, a novel quadripolar active fixation LV lead (Medtronic) was released. This paper reports the initial clinical experience with lead implantation and specifically immediate and short-term pacing parameters across 3 United Kingdom centers. Consecutive patients eligible for CRT were deemed suitable for this lead. Immediate and short-term lead performance data regarding LV threshold, impedance, and displacement rates were collected at standard pacing checks (1day, 5weeks, 3months, and 9months post-implantation). CRT using this lead was attempted in 82 cases and was successful in 81 cases (98.8%). LV thresholds and impedance levels were 1.22 ± 0.75V and 737 ± 319Ω at implantation; 1.16 ± 0.71V and 597 ± 218Ω at day 1; 1.02 ± 0.48V and 579 ± 148Ω at week 6; 0.98 ± 0.49V and 569 ± 133Ω at 3months; and 1.06 ± 0.48V and 570 ± 140Ω at 9months. As of the publication of this paper, no LV lead has been displaced. CRT using the Medtronic lead was successful in more than 98% of the patients. Short-to-medium-term data regarding lead performance and stability were excellent, with zero displacements as of the publication of this paper.

His Bundle Pacing is Potentially Superior to Biventricular Pacing Systems

His-bundle pacing (HBP) has gained exponential recognition as a potentially effective strategy to circumvent the problems of chronic right ventricular (RV) pacing in pace-dependent patients. A 76-year-old man presented with New York Heart Association class III symptoms and worsening left ventricular (LV) function (LV ejection fraction 30%) after a pacemaker and atrioventricular nodal ablation for incessant atrial tachycardia/atrial fibrillation not curable with multiple ablations. A cardiac resynchronisation therapy upgrade was attempted; however, owing to high LV thresholds and phrenic stimulation at low output, HBP was performed. Following HBP, the RV-paced QRS width improved from 160 ms (old RV pace) to 133 ms (BiV pace). His pacing alone resulted in a paced QRS of 120 ms. This case confirms the feasibility of HBP as a strategy to potentially improve pacing-induced ventricular dyssynchrony. This strategy could well be an alternative for failed LV pacing and potentially be a first line treatment in selected patients due to one-third non–response rates with LV pacing, and the potential for superior outcomes. Further studies are needed to confirm long-term outcomes.

Super-response to cardiac resynchronization therapy may predict late phrenic nerve stimulation.

Changes in the anatomical relationship between left phrenic nerve and coronary veins may occur due to the reverse remodelling observed in super-responders to cardiac resynchronization therapy (CRT) and might be the underlying mechanism in patients developing late-onset phrenic nerve stimulation (PNS) without evidence of lead dislodgement (LD). In this study, we sought to evaluate the role of super-response (SR) to CRT as a potential predictor of late-onset PNS. Consecutive patients implanted with a left ventricular (LV) lead in a single centre were retrospectively analysed. Phrenic nerve stimulation was classified as 'early' when it occurred within 3 months of implantation and 'late' for occurrences thereafter. 'Late' PNS was considered related to LD (LD-PNS) when LV threshold differed by > 1 V or impedance >250 Ω from baseline values or in case of radiological displacement. Cases not meeting the former criteria were classified as 'non-LD-PNS'. Super-response was defined as a decrease ≥30% of the left ventricluar end-systolic volume at 1-year echocardiography. At 32 ± 7 months follow-up, PNS occurred in 20 of 139 patients. Late non-LD-PNS incidence was significantly higher in the SR group (8/61; 13.1%) when compared with the non-SR (1/78; 1.3%) (P = 0.010). Super-response remained the only predictor of non-LD-PNS at multivariate analysis (odds ratio: 11.62, 95% confidence interval 1.41-95.68, P = 0.023). Incidence of late non-LD-PNS is higher among SR to CRT, suggesting a potential role of the changes in the anatomical relationship between left phrenic nerve and coronary veins.

Alternative to left ventricular lead implantation through the coronary sinus: 1-year experience with a minimally invasive and robotically guided approach.

Left ventricular (LV) lead implantation through the coronary sinus (CS) can be limited and sometimes not possible-alternative approaches are needed. Minimally invasive, robotically guided LV lead implantation has major advantages, but there are little published data about the short- and long-term follow-ups, in terms of feasibility, safety, electrical performance, and impact on clinical outcome. A total of 21 heart failure patients underwent robotically guided LV lead implantation using the Da Vinci Robotic System. Indications were failed implant with conventional approach through the CS (n = 16) and non-response to conventional cardiac resynchronization therapy (n = 5). During the procedure, the entire LV free wall was exposed through 3 transthoracic ports (10 mm diameter each) allowing ample choice of stimulation site and the ability to implant 2 LV leads via a Y connector. Patients were prospectively followed up for 1 year. The two LV leads were successfully implanted in all patients. No peri-procedural complications were observed. After a mean stay in the intensive care unit of 1.2 ± 4 days, the 21 patients were hospitalized in the EP department for 6.7 ± 2.9 days. Acute LV thresholds were excellent (1.0 V ± 0.6/0.4 ms) and stayed stable at 1-year follow-up (1.5 V ± 0.6/0.4 ms, P = 0.21). Four patients demonstrated an increased threshold (>2 V/0.4 ms). There was no phrenic nerve stimulation. After 12 months, in the failed implant group, 69% of the patients were echocardiographic and clinical responders. The robotic approach was feasible, safe, and minimally invasive. Accordingly, robotically guided LV lead implantation seems to offer a new alternative when conventional approaches are not suitable.

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of <0.5 V in 77% of patients and <1 V in 95%. Device longevity analysis showed that the use of a 0.5-V safety margin increased average battery longevity by 0.62 years (95% confidence interval 0.61 to 0.63) compared with a safety margin of 1.5 V. Patients with LV PCTs >1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity.

Phrenic nerve stimulation in CRT patients and benefits of electronic lead repositioning: the ERACE trial

Despite novel left ventricular (LV) lead technologies, phrenic nerve stimulation (PNS) remains an adverse effect observed in many patients with cardiac resynchronization therapy (CRT). Beyond anatomic repositioning, modern CRT devices allow avoidance of PNS also by software-based adaption of the pacing configuration. The Electronic Repositioning With Acuity and Easytrak Leads study evaluated the incidence of PNS in a CRT population and examined how often LV lead relocation can be avoided by "electronic repositioning" (ER). Patients who had an indication for implantation of a first CRT defibrillator with the option of ER were enrolled. Primary endpoint was the efficiency of ER determined by the frequency of PNS with the standard pacing configuration (LV tip to RV coil) avoidable by ER. PNS and pacing parameters were evaluated during implant, predischarge, and first routine follow-up (FU) using four different pacing configurations available by ER. In total, 292 patients were enrolled and provided with a transvenous LV lead (82.2 % male, 65.5 ± 9.2 years old). The majority of the population was in NYHA III (84.2 %) with a LV ejection fraction of 25.3 ± 6.8 % and mean QRS width of 155 ± 27 ms, ischemic cardiomyopathy was present in 43.6 %. Median FU was 116 days. In the standard pacing configuration, PNS was inducible in 19.0/25.6/24.6 % at implant/predischarge/FU, respectively, resulting in 32.2 % of the patients presenting at least once with PNS. The safety margin for the standard pacing configuration between LV and PNS threshold was <1.0 V at 0.5 ms in 5.6/7.0/5.0 % of the patients, corresponding with a total rate of 11.6 % during the FU. In the finally chosen configuration, clinically relevant PNS occurred in 1.0/2.2/1.3 %. The four vector configurations allowed all but 6 of 292 (2 %) patients to be reprogrammed using ER without reoperation. The incidence of inducible PNS in CRT patients is considerable. In this study, PNS could be avoided in the majority of the patients by means of electronic repositioning. Thus, the use of ER should be considered for CRT patients.

Comparison of Different Pacing Strategies to Minimize Phrenic Nerve Stimulation in Cardiac Resynchronization Therapy

Phrenic nerve (PN) stimulation (PNS) frequently limits cardiac resynchronization therapy (CRT). Yet, pacing strategies to minimize PNS have not been systematically compared. We propose to: (1) compare different pacing strategies to minimize PNS in CRT and (2) evaluate differences between PN and left ventricular (LV) capture thresholds among LV pacing configurations. PN and LV thresholds were obtained using 6 LV configurations in 28 patients with any PNS during CRT implantation or replacement. Incidence of PNS was compared in all LV configurations by programming pacing output to (1) One Volt (V) above LV threshold, (2) triple pulse width (PW) at LV threshold, and (3) 1.5 times LV threshold for each patient. PN thresholds and PN strength-duration curves were statistically different between configurations (P < 0.05). Ring→RVcoil and Ring→Can had the largest difference between PN and LV thresholds. Pacing output programmed to 1.5 times LV threshold, 1 V above LV threshold, and triple PW at LV threshold had similar probability of PNS between LV configurations. However, 1 V above LV threshold and triple PW at LV threshold frequently resulted in poor (< 30%) LV capture safety margin (14-43% and 53-68%, respectively). Freedom from PNS (programmed output at twice LV threshold) was found in 88%, 84%, and 52% with 6, 3, or 2 available LV configurations, respectively. Multiple LV pacing configurations marginally increase the probability of avoiding PNS by electronic reprogramming. Pacing output programmed to 1.5 times LV threshold is an additional alternative to minimize PNS when electronic reprogramming options are limited.

Disparity in Left Ventricular Stimulation Among Different Pacing Configurations in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy (CRT) demands high energy utilization due to continuous biventricular pacing. Current technology allows 6 pacing configurations for a bipolar left ventricular (LV) lead. Understanding the energy requirements for each configuration will allow optimization of pacing output. Pacing impedance, LV voltage threshold at 1.5 ms (rheobase) and 0.4 ms and chronaxie were obtained in 6 LV configurations in 49 consecutive patients undergoing CRT implantation or replacement. Strength-duration curves were derived using the Lapicque formula. Pacing impedances and voltage thresholds at 1.5 and 0.4 ms, calculated minimum threshold energy at chronaxie, current drain, energy thresholds at 0.4 ms, and strength-duration curves were statistically different between LV configurations (P<0.05). The lowest threshold energy requirements were found in Tip→right ventricular (RV) coil and Tip→Can configuration. Energy strength-duration curves involving the ring as the cathode (Ring→RV, Ring→Can, and Ring→Tip) had the highest LV thresholds. The pacing configuration with the lowest energy threshold correlated 89% of the time with the lowest voltage threshold at 0.4 ms. The probability to reach LV thresholds <1.5 V at 0.4 ms was increased from 51% with 2 LV configurations to 67% with 6 LV configurations. Pacing impedance, LV thresholds, minimum threshold energy at chronaxie, current drain, voltage, and energy strength-duration curves were statistically different between LV pacing configurations. LV pacing configuration with the lowest voltage threshold does not always reflects the lowest energy threshold, particularly in the presence of a low impedance configuration. The availability of 6 LV configurations increases the probability of optimizing LV pacing output.

Anatomical factors involved in difficult cardiac resynchronization therapy procedure: a non-invasive study using dual-source 64-multi-slice computed tomography

In cardiac resynchronization therapy (CRT) procedure, left ventricular (LV) lead implantation is time consuming. In this clinical setting, no study has investigated the impact of right atrium anatomical parameters on both CRT implantation procedure duration and X-ray exposure. Additionally, only few studies have examined the coronary sinus (CS) using dual-source 64-multi-slice computed tomography (DS 64-MSCT), and its impact on CRT procedure parameters has not yet been investigated. The aim of this prospective study was to identify local anatomical predictive factors of difficult CRT implantation procedure using DS 64-MSCT. Between January and July 2010, 50 consecutive patients underwent primo CRT implantation. The patient population had a mean age of 70 ± 10 years, and was 34% female, with New York Heart Association Class 3.2 ± 0.3 heart failure, left ventricle ejection fraction 30 ± 4%, and QRS width 157 ± 30 ms. Cardiac resynchronization therapy implantation was attempted in 50 patients, and first LV lead implantation was obtained in 49 of 50 patients (98% primary success). One implantation failed (2%) due to unsuccessful LV lead implant. Procedure parameters were as follows: LV threshold, 1.4 ± 0.8 V; LV wave amplitude, 17 ± 8 mV; LV impedance, 830 ± 240 Ω; median procedure time (skin to skin), 51 min (38 min); median fluoroscopy procedure time, 11.9 min (22 min); and median LV fluoroscopic time, 10.3 min (22 min). In 10 patients (20%), procedures were difficult requiring an implantation lasting ≥ 85 min. The only predictive factor for difficult CRT implantation was the insertion level of the CS ostium (CSO), evaluated by the distance between the CSO and the bottom floor of the right atrium (14.8 ± 4 vs. 9.5 ± 4; P= 0.01). Neither the right atrium dilation nor right ventricular dysfunction was associated with difficult CRT implantation procedures. Today, despite improvements in the materials used, problems still remain in the CRT procedure. In this clinical setting, the only predictive factor for very long CRT procedures is the CSO-level insertion (located high). This anatomical anomaly identified by DS 64-MSCT prior to surgery is responsible for 20% of difficult CRT device implantation procedures.

The effects of anodal stimulation on electrocardiogram, left ventricular dyssynchrony, and acute haemodynamics in patients with biventricular pacemakers

Anodal stimulation (ANS) is a recognized phenomenon among patients with cardiac resynchronization therapy (CRT); this is noted during left ventricular (LV) pacing by the LV tip to right ventricular (RV) ring configuration. Its incidence varies according to the implanted hardware. We aim at evaluating the incidence of ANS and its acute haemodynamic effects among CRT patients. We screened all our patients who previously had an implanted CRT-P/D devices for ANS. After excluding all non-eligible devices, the initial screening was done by evaluating the programmer electrocardiogram (ECG) during device interrogation while pacing LV only from LV tip to RV ring. Those with ANS underwent screening by 12-lead ECG during biventricular pacing with VV interval programmed to 0. Patients with electrocardiographic evidence of ANS underwent detailed echocardiography. We screened 224 patients, 187 patients were excluded due to various causes. Thirty-seven subjects were analysed for this study. Anodal stimulation was found in 29 patients (78.4%) by primary screening. Twelve patients (41.4%) showed electrocardiographic evidence of ANS by 12-lead ECG. The ANS threshold was significantly higher than true bipolar LV threshold (4.5±1.7 vs. 1.1±0.3 V, respectively, P=<0.0001). Ten patients, with ECG evidence of ANS, underwent detailed echocardiography during biventricular pacing with and without ANS. Overall, there were no significant differences in the haemodynamic, echocardiographic, or resynchronization effects with and without ANS, two patients showed significant reduction in LV function with ANS. Anodal stimulation is a common phenomenon among CRT patients. In many cases ANS is seen with LV pacing only, while these changes may not be seen by ECG during biventricular pacing. Echocardiography did not show any significant acute haemodynamic benefit during ANS, and some patients may even deteriorate.

The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation

Cardiac resynchronization therapy (CRT) improves survival and reduces heart failure symptoms. However, phrenic nerve stimulation and high pacing thresholds are common problems that limit CRT effectiveness. Current technology allows reprogramming of left ventricular (LV) pacing vectors, permitting 'electronic repositioning' to overcome both phrenic nerve stimulation and high pacing output without the need for re-operation. Patients underwent prospective evaluation of a CRT system implantation with a bipolar LV. Optimal LV threshold and avoidance of phrenic nerve stimulation were determined at baseline and at 6 months. A subset of 48 patients underwent more detailed evaluation of pacing threshold and phrenic nerve stimulation at baseline and at 6 months. Between 2004 and 2007, 228 patients underwent CRT implantation (64 CRT pacemakers, 164 CRT defibrillators). At baseline, electronic reprogramming to determine an alternate configuration compared with standard LVtip to LVring found a ≥ 1.0 V reduction in pacing threshold in 80 patients (35%). Of the 17 patients who had an LVtip to LVring configuration and high pacing threshold (>5.0 V), 16 could be reduced by >1.0 V (94%) and 11 could be reduced by >2.0 V through electronic repositioning alone without repositioning the lead (65%). At implant, there were 48 patients with phrenic nerve stimulation at less than maximum pacing output (21%) using the standard LVtip to LVring configuration. In 37 cases (77%), there was at least one other configuration with no phrenic nerve stimulation, which prevented the need for lead revision. Electronic repositioning is an important tool in the management of CRT patients which may help to lower thresholds, avoid phrenic nerve stimulation, and prevent unnecessary re-operations for LV lead repositioning.

Left ventricular lead implantation at a phrenic stimulation site is safe and effective

Phrenic stimulation (PS) is a major limiting factor for both left ventricular (LV) lead placement and cardiac resynchronization therapy (CRT) delivery. We have developed a protocol allowing for LV lead implantation at a PS site based on specific criteria regarding phrenic and LV acute capture thresholds. The present study examined long-term outcomes in patients treated using this protocol. A total of 211 consecutive patients underwent CRT device implantation. The procedure was successful in 201 patients. Leads were implanted at a PS site in 27 patients (PS patients) and a non-PS site in 174 patients (non-PS patients). Left ventricular leads were placed at a PS site only on the following conditions: no PS at ≤3.5 V/0.5 ms, LV threshold ≤1.5 V, and a PS/LV threshold ratio >4. The mean PS threshold decreased (5.1 ± 1.6 vs. 2.8 ± 1.6 V, P < 0.001) and the mean LV threshold remained stable (1.0 ± 0.7 vs. 0.9 ± 0.8 V, P = 0.6) in PS patients over the 16 ± 9 month follow-up. Only one PS patient experienced non-reprogrammable PS and required a re-operation. Seven PS patients required very low LV channel output programming without the usual safety margin of twice the LV threshold amplitude or three times the pulse width. However, 100% LV capture was shown in those patients during daily activity. Non-reprogrammable PS occurred in 2 of the 174 non-PS patients. Our strategy for LV lead implantation at a PS site was found to result in long-term safe and effective outcomes.

184 Predictive factors of difficult implantation procedure in cardiac resynchronization therapy

No studies have been published regarding factors related to difficult CRT implantation procedure and primary left ventricular (LV) lead implant failure. The aim of this prospective study was twofold: (1) to evaluate the prevalence and predictive factors of prolonged CRT implantation procedure; (2) to identify the predictive factors of primary LV lead implantation failure. Between November 2008 and September 2009, 106 pts underwent primo CRT implantation. Population characteristics were a mean age of 69 ± 10 years; 28.3% female; NYHA class 3.2 ± 0.3; LVEF (29 ± 6%); QRS width 146 ± 23 ms. Primo CRT implantation was obtained in 96/106 pts (90.5% primary success). A second procedure was successfully attempted in 6/10 pts with a second more experienced operator (5.7%). Among the remaining 4 pts, 1 pt required an epicardial LV lead implantation, and the implantation was not reattempted in the other 3 pts. The overall success rate of CRT implantation was 96.2% (102/106 pts). Procedure parameters were as follows: LV threshold (1.4 ± 0.9V); LV wave amplitude (15 ± 8 mV); LV impedance (874 ± 215 Ohms); median procedure time (skin to skin), 55 min. [45–80] and median of procedure fluoroscopy time, 11 min. [6.2–29]. In 24 patients (22.6%), difficult procedures requiring 85 min of implantation duration occurred. By univariate analysis, predictive factors of difficult implantation were LV ejection fraction (25.6 ± 6 vs. 30.2 ± 8%; p = 0.02), LVEDD (72.4 ± 11 vs. 66 ± 11 mm; p = 0.01), LVESD (62 ± 12 vs. 56 ± 12 mm; p = 0.04) and the operator's experience (very experienced operator vs. less experienced operator; p = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD and operator's experience were independently associated with difficult procedures. In this patient subset with primary LV lead implant failure (n = 10), the only independent predictive factor was the LVESV (p = 0.03). In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operator's experience were independent predictors of surgical difficulties.

Phrenic stimulation management in CRT patients: are we there yet?

Phrenic stimulation may hinder left-ventricular (LV) stimulation and prevent cardiac resynchronization therapy (CRT) delivery. We reviewed the literature to address its prevalence and clinical implications in CRT patients. Phrenic stimulation prevalence ranges from 20 to 33% of patients when a posterolateral LV lead placement is aimed. False-negatives are common during implantation, sensitivity being about 60-80%. Symptoms may dictate repositioning the LV lead, meaning risk of lead dislodgement, decreased CRT efficacy, or high LV threshold. CRT turn-off occurred in 2% of patients because of refractory phrenic stimulation. Several strategies have been used to manage phrenic stimulation: whereas lead repositioning was the only one available in early CRT experience, the use of bipolar/multipolar leads combined with cathode programmability enabling several pacing configurations has made possible targeting the optimal LV pacing sites in nearly all patients.Despite technological improvements, phrenic stimulation symptoms are sporadically reported by 6-8% of patients at follow-up, meaning that there is still an unmet need to address this problem. Phrenic stimulation needs to be carefully managed at implantation and follow-up. Use of bipolar/multipolar leads and of multiple pacing configurations is mandatory to increase the chances of managing phrenic stimulation. Active fixation LV leads, hopefully bipolar, could further increase the success rate.

Predictive factors of difficult implantation procedure in cardiac resynchronization therapy

The usefulness of cardiac resynchronization therapy (CRT) in patients with congestive heart failure is offset by its long, user-dependent, and technical procedure. No studies have been published regarding factors related to CRT implantation procedure duration and X-ray exposure. Additionally, only a few studies have investigated the predictive factors of primary left ventricular (LV) lead implant failure. The aim of this prospective study was two-fold: (i) to evaluate the prevalence and predictive factors of prolonged CRT implantation procedure and (ii) to identify the predictive factors of primary LV lead implantation failure. Between November 2008 and September 2009, 128 consecutive patients underwent CRT implantation; of these, 22 patients (17.2%) were excluded because of CRT generator replacement. Population characteristics were a mean age of 69 +/- 10 years, 28.3% female, New York Heart Association class 3.2 +/- 0.3, LV ejection fraction (LVEF; 29 +/- 6%), and QRS width 146 +/- 23 ms. Cardiac resynchronization therapy implantation was attempted in 106 patients, and first LV lead implantation was obtained in 96 of 106 patients (90.5% primary success). Ten primary implantations failed (9.5%), due to unsuccessful LV lead implants. A second procedure was successfully attempted in six patients with a second more experienced operator (5.7%). Among the remaining four patients, one patient required a surgical epicardial LV lead implantation, and the implantation was not reattempted in the other three patients. The overall success rate of CRT system implantation was 96.2% (102 of 106 patients). Procedure parameters were as follows: LV threshold (1.4 +/- 0.9 V); LV wave amplitude (15 +/- 8 mV); LV impedance (874 +/- 215 ohm); median procedure time (skin to skin), 55 min (45-80); and median of procedure fluoroscopy time, 11 min (6.2-29). In 24 patients (22.6%), difficult procedures requiring >or=85 min of implantation duration occurred. By univariate analysis, predictive factors of difficult implantation were LV ejection fraction (25.6 +/- 6 vs. 30.2 +/- 8%; P = 0.02), LV end-diastolic diameter (72.4 +/- 11 vs. 66 +/- 11 mm; P = 0.01), LV end-systolic diameter (LVESD; 62 +/- 12 vs. 56 +/- 12 mm, P = 0.04), and the operator's experience (very experienced operator vs. less experienced operator, P = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operator's experience were independently associated with difficult procedures. In this patient subset with primary LV lead implant failure (n = 10), the only independent predictive factor was the LV end-systolic volume (P = 0.03). In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operator's experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.

Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators

AimsThe Secura™ ICD and Consulta™ CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population.Methods and resultsTwo prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 ± 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were ≤0.25 V in 97% (RA CM) and 96% (RV CM) and were all within the safety margin. Fully automatic CM measurements were available within 1 week prior to the 3-month visit in 90% (RA), 99% (RV), and 97% (LV) of the patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate.ConclusionComplete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity.The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.

Phrenic Stimulation

Background— Phrenic stimulation (PS) may hinder left ventricular (LV) pacing. We prospectively observed its prevalence in consecutive patients with cardiac resynchronization therapy (CRT) devices. Methods and Results— In the years 2003 to 2006, 197 patients received a CRT device. PS and LV threshold measurements were carried out at implantation and at 6-month follow-up. LV reverse remodeling was assessed by echocardiography before implantation and at follow-up. LV lead placement was lateral/posterolateral in 86% of patients. Both PS and LV reverse remodeling occurred most frequently at the lateral/posterolateral LV pacing sites ( P &lt;0.001). PS was detected in 73 (37%) of patients and was clinically relevant in 41 (22%). The detection of PS at implantation had a poor sensitivity, as it occurred only in left lateral or sitting position in 27 patients. Ten patients (5%) underwent repeated surgery and 4 (2%) had their CRT turned off because of PS. At follow-up, we could manage PS noninvasively in 32 patients with a small PS-LV threshold difference: in 20 by cathode programmability (3 also thanks to automatic management of LV output) and in 12 (without cathode programmability) by programming the LV output as threshold +1 V. Conclusions— PS may seriously hinder CRT. A bipolar LV lead and cathode programmability are mandatory to avoid PS by changing the LV pacing vector at target sites for CRT. LV stability at target sites despite PS should also be pursued by these means. The automatic adjustment of LV pacing output is complementary in patients with a small PS-LV threshold difference.