Safety of catheter ablation in patients with recently implanted cardiac implantable electronic device: A 5-year experience.

INTRODUCTION: Catheter ablation (CA) can interfere with cardiac implantable electronic device (CIED) function. The safety of CA in the 1st year after CIED implantation/lead revision is uncertain. METHODS: This single center, retrospective cohort included patients who underwent CA between 2012 and 2017 and had a CIED implant/lead revision within the preceding year. We assessed the frequency of device/lead malfunctions in this population. RESULTS: We identified 1810 CAs in patients between 2012 and 2017, with 170 CAs in 163 patients within a year of a CIED implant/lead revision. Mean age 68 ± 12 years (68% men). Time between the CIED procedure and CA was 158 ± 99 days. The CA procedures included AF ablation (n = 57, 34%), AV node ablation (n = 40, 24%), SVT ablation (n = 37, 22%), and PVC/VT ablations (n = 36, 21%). The cumulative frequency of lead dislodgement, significant CIED dysfunction, and/or CIED-related infection following CA was (n = 1/170, 0.6%). There was a single atrial lead dislodgement (0.6%). There were no instances of power-on-reset or CIED-related infection. Following CA, there was no significant difference in RA or RV lead sensing (p = 0.52 and 0.84 respectively) or thresholds (p = 0.94 and 0.17 respectively). The RA impedance slightly decreased post-CA from 474 ± 80 Ohms to 460 ± 73 Ohms (p = 0.002), as did the RV impedance (from 515 ± 111 Ohms to 497 ± 98 Ohms, p < 0.0001). CONCLUSIONS: CA can be performed within 1 year following CIED implantation/lead revision with a low risk of CIED/lead malfunction or lead dislodgement. The ideal time to perform CA after a CIED remains uncertain.

Chronic phase subcutaneous implantable cardioverter defibrillator lead dislodgement in a patient with arrhythmogenic right ventricular cardiomyopathy.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is often used in young patients such as arrhythmogenic right ventricular cardiomyopathy (ARVC) and Brugada syndrome due to long-term lead durability issues. Although S-ICD lead dislodgement is rare, we encountered such an incident in a young ARVC patient during the chronic phase following the two-incision technique. Remote monitoring system is useful for early diagnosis of electrode movement (Graphical abstract image). When S-ICD lead dislodgement occurs in active young patients, lead revision using the three-incision technique may be an option.

A rare case of delayed complete lead dislodgement after deep septal pacing: A hidden risk of the specific procedure.

Deep septal ventricular pacing is a recently developed physiological pacing modality with good efficacy; however, it has a potential risk of unusual complications. Here, we report a patient with pacing failure and spontaneous, complete lead dislodgement after >2 years of deep septal pacing, possibly caused by systemic bacterial infection and specific lead behavior in the septal myocardium. This case report may implicate a hidden risk of unusual complications in deep septal pacing.

Tricuspid regurgitation and infective endocarditis as a cause of lead dislodgement in left bundle branch area pacing.

BACKGROUND: According to the current literature, there is no difference between left bundle brunch area pacing (LBBAP) and right ventricular apical pacing in terms of lead dislodgement and capture threshold elevation. However, there are no large-scale studies reporting the data about long-term lead stability in patients with severe tricuspid regurgitation. METHODS AND RESULTS: We present a case of lead dislodgement with possible infective endocarditis six months after implantation in a patient with severe tricuspid regurgitation who underwent LBBAP. CONCLUSIONS: We concluded that severe preoperative tricuspid regurgitation may cause lead dislodgement, and infective endocarditis may be a facilitator or main reason of lead dislodgement in cases of LBBAP.

Relationship between device displacement distance toward the caudal side during standing and pocket position laterality.

BACKGROUND: The displacement of cardiac implantable electronic devices (CIEDs) toward the caudal side during standing after CIED implantation could cause lead dislodgement. This study investigated the relationship between supine pocket position and standing CIEDs' displacement distance after the implantation. METHODS: After CIED surgeries performed at 2 hospitals between 2012 and 2020, 134 patients underwent postoperative chest x-rays in the supine and standing positions during hospitalization. To measure the displacement distance of CIEDs from the supine to the standing position, we identified the first thoracic vertebrae (Th1) in the supine position using the first rib as an index, drew a horizontal line at the lower edge of the Th1, and calculated the distance from that point to the upper edge of the CIED. The difference between measures for the two positions was compared. At the position of the pocket in the thorax in the supine position, the ratio of the distance between the thorax and the device is defined as the device thorax ratio (DTR). We examined the relationship between DTR and CIED displacement distance. RESULTS: In this study, we included 134 patients (53% men; median age, 79 years, body mass index, 22.3 ± 3.4; pacemaker 93%, left implantation 96%). We found that the more lateral the position of the CIED pocket, the more the CIED fell when standing (confidence interval = 0.34-0.60, P < .001). CONCLUSIONS: The farther the CIED was implanted outside the thorax in the supine position, the more significantly the CIED was displaced in the standing position.

A sudden change in pacing rate: Normal or malfunction?

A woman with a dual-chamber pacemaker was examined for recurrent chest discomfort and palpitations at our hospital. The Holter monitor test recorded recurrent episodes of a sudden increase in pacing rate from 60 to 105 bpm, which corresponded to the symptoms. Orthodromic pacemaker-mediated arrhythmia (OPMA), caused by ventricular lead dislodgement and atrial far-field sensing, caused the recurrent episodes of a sudden change in pacing rate. The occurrence of OPMA may represent a rare but noteworthy pacemaker problem. To our knowledge, our study reports the first case of PMA that only occurs, and is maintained, in the DDI mode.

Delayed presentation of pacemaker Reel Syndrome and lead damage: Coincidence or consequence?

Reel syndrome is a pacemaker lead early dislodgment, characterized by reeling-in of the lead(s) without being damaged. We herein present a case of an 86-year-old woman, with medical history of single chamber pacemaker implantation two years ago, admitted in cardiology department with complete AV block. Chest-Xray revealed ventricular lead coiling around and behind the pacemaker device. Urgent extraction of the previous pacemaker was performed; however, the lead damage made its repositioning unfeasible. Successful implantation of single-chamber pacemaker has been made. This clinical case highlights the importance of adequate follow-up to timely identify lead dislodgement, avoid lethal complications and lead fracture.

Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead versus a passive quadripolar lead.

Objectives: To compare the clinical outcome of cardiac resynchronization therapy (CRT) in patients receiving a bipolar left ventricular (LV) lead with a side helix for active fixation to the outcome in patients receiving a quadripolar passive fixation LV lead.Design: Sixty-two patients (mean age 72 ± 11 years) were blindly and randomly assigned to the active fixation bipolar lead group (n = 31) or to the quadripolar lead group (n= 31). The LV leads were targeted to the basal LV segment in a vein concordant to the LV segment with the latest mechanical contraction chosen on the basis of preoperative radial strain (RS) echocardiography.Results: At the 6-month follow-up (FU), the reduction in LV end-systolic volume and LV reverse remodelling responder rate, defined as LV end-systolic volume reduction >15%, was 77% in the active fixation group and 83% in the quadripolar group, which was not significantly different. At the 12-month FU, the LV ejection fraction (LVEF) did not differ between the groups. There were no significant differences between the two groups in changes in New York Heart Association (NYHA) functional class or Minnesota Living with Heart Failure Questionnaire score. The occurrence of phrenic nerve stimulation (PNS) was 19% in the active fixation group versus 10% in the quadripolar group (p=.30), and all cases were resolved by reprogramming the device. All patients were alive at the 12-month FU. There was no device infection.Conclusions: There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.ClinicalTrials.gov number, NCT04632472.

Ventricular asystole in the presence of a biventricular device.

In pacemaker-dependent patients with a newly implanted cardiac device, acute lead dislodgement constitutes one of the most common causes of loss of capture and ventricular asystole. In a biventricular system, it would be expected that such a potentially catastrophic event would be prevented with back-up right ventricular pacing unless both leads dislodge.

Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results.

INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.

S-ICD lead dislodgement in a young isometric athlete: A rare complication.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is an alternative to transvenous ICD in patients who do not need cardiac pacing. We report the case of a young isometric athlete who received S-ICD for primary prevention of sudden death. Lead dislodgement and myopotential noise oversensing during isometric training led to inappropriate shock, and a surgical revision was performed. During the procedure, strong fibrous adhesions were found, requiring polytetrafluoroethylene dilator sheaths. The S-ICD was finally reimplanted. Despite continued isometric training, no more myopotential oversensing occurred after 1-year follow-up. The present case highlights the possible higher risks of lead complication in an isometric athlete and the uncommon effort in removing an old-generation subcutaneous defibrillator lead.

Comprehensive strategy to reduce the incidence of lead dislodgement for cardiac implantable electronic devices.

BACKGROUND: Lead dislodgement (LD) is a well-recognized complication during implantation of cardiac implantable electronic devices (CIEDs). An intraprocedural protocol, referred to as reduction of LD protocol, was developed to reduce the risk of LD. METHODS: The protocol involved (1) inserting a straight stylet down the right atrial lead and applying forward pressure while monitoring for fluoroscopic stability, (2) visualizing all leads during deep inspiration to determine if there is adequate lead redundancy, and (3) having the patient take a deep breath and cough while pacing just at capture threshold to assess for loss of capture in each lead. Any intraprocedural change in the parameters fulfilling the predefined criteria for inadequate lead implantation prompted lead repositioning. Data regarding demographic factors, clinical characteristics, and incidence of LD in the first 30 days after implant was obtained from intramural CIED database. The preintervention (control) group spanned 27 months and consisted of a total of 4,294 leads while the postintervention (intervention) group spanned 17 months and consisted of 2,361 leads implanted. RESULTS: There was no significant difference in the demographic factors and clinical characteristics in the two groups. Protocol compliance was > 90%. There were 44 occurrences of LD (1.02%) before and 10 (0.4%) after implementation of the protocol. The protocol significantly reduced the incidence of LD during the 30 days after implant (P = 0.014). No clinical characteristic predicted the risk of LD. CONCLUSION: Intraprocedural maneuvers performed to assess the adequacy of lead implantation results in reduced risk of LD.

Transvenous retrograde reposition of an atrial lead.

Pacemaker lead dislodgement is one of the most undesired complications of pacemaker implantation. Repeated procedures are associated with an increased risk of complications, such as pocket infection, pneumothorax, and hematoma. We present a case who experienced dislodgement of the atrial pacemaker lead of a cardiac resynchronization therapy with defibrillator implantation device, which was corrected using a steerable ablation catheter by the transfemoral route.

Impact of intraoperative mechanical ventilation on left ventricular lead function in cardiac resynchronization therapy.

BACKGROUND: Intraoperative controlled mechanical ventilation (CMV) changes the intrathoracic geometry and may impact postoperative left ventricular (LV) lead function after CRT implantation. This multicenter study investigates the effect of intraoperative ventilation setting (spontaneous breathing [SB] vs CMV) on postoperative LV lead function taking into account patients' body mass index (BMI). METHODS: CRT implantation was performed at two centers during SB in 92 and during CMV in 73 patients. Follow-up was carried out after 3 ± 5 and 36 ± 53 days. Functional lead parameters (FLP; pacing threshold and impedance), postoperative adverse events (A;  phrenic nerve stimulation [PNS] and lead malfunction), and patients' BMI were assessed. Delta values of FLP between baseline and follow-up visits were analyzed applying an analysis of covariance model to detect subclinical alterations in LV lead function. RESULTS: AE occurred in a total of 36 (21%) patients. PNS was observed in 26 (15%) patients and LV lead repositioning due to malfunction was necessary in 10 (6%) patients. Both AE and FLP delta values between baseline and follow-up were not associated with intraoperative ventilation settings nor the patients' BMI. CONCLUSIONS: This study demonstrates that there is no impact of the intraoperative ventilation setting (SB vs CMV) on postoperative FLP or the occurrence of AE. This is also the case taking into account the BMI. With respect to these findings both approaches-sedation only or general anaesthesia including CMV-can be safely implemented during CRT implantation.

Inadvertent pacemaker lead dislodgement.

Transcatheter aortic valve implantation (TAVI) has become an established treatment option for aortic valve stenosis in patients with a high risk for conventional surgical valve replacement. A well-known complication is the development of conduction abnormalities. In the case of a new third-degree atrioventricular block, the complication can be life-threatening and permanent pacing is needed. Often these patients have a venous sheath placed in the jugular vein for the perioperative period. We report a case of inadvertent dislodgement of a permanent pacemaker lead after removal of a preoperatively placed venous sheath in a TAVI patient.

Meta-analysis of the incidence of lead dislodgement with conventional and leadless pacemaker systems.

INTRODUCTION: Leadless cardiac pacemaker (LCP) implantation using a transcatheter was recently developed to avoid pocket- and lead-related complications. Although a LCP has an active fixation mechanism using tines or a helix, LCP and lead dislodgement issues remain a major safety concern for patients. This article reviews the literature to determine the incidence of lead and LCP dislodgement. METHODS AND RESULTS: A total of 18 studies which included 17,321 patients undergoing conventional single- or dual-chamber pacemaker implantation and three studies which included 2,116 patients undergoing LCP device implantation were reviewed. The incidence of lead dislodgement ranged from 1% to 2.69% in individual studies with a mean of 1.63%, weighted mean of 1.71%, and median of 1.60 %. There was a relatively higher lead dislodgement rate between atrial and ventricular electrodes (odds ratio [OR], 3.56; 95% confidence interval [CI], 1.9-6.70; P  =  0.6; I2   =  0%), and between magnetic resonance imaging conditional and conventional leads (OR, 2.79; 95% CI, 1.30-5.99; P  =  0.16; I2   =  46%). The use of active fixation leads (OR, 1.06; 95% CI, 0.66-1.70; P  =  0.29; I2   =  20%) showed no significant difference in dislodgement risk compared to passive fixation leads. The incidence of LCP device dislodgement was 0%, 0.13%, and 1% in three leadless pacemaker studies. CONCLUSIONS: The incidence rates of conventional pacemaker lead dislodgement vary in individual studies with an overall high incidence. Use of the currently available LCP systems appears to result in a lower rate of device dislodgement. This may reflect the effectiveness of this novel technology and the fixation design of LCP devices.

"Spontaneous Twiddler's" Syndrome: The Importance of the Device Shape.

Twiddler's syndrome is caused by patient manipulation of the cardiac implantable device (CID) around its central axis within the pocket, resulting in retraction and dislocation of the electrodes. There are, however, some reports that Twiddler's syndrome may occur spontaneously without the patient's manipulation. This remains contentious as it may be argued that patients may not want to admit to manipulating the CID or may have been unaware of their actions. Recently, we have observed three very similar cases with a "spontaneous" Twiddler's syndrome resulting in lead displacement. All of the three patients denied device manipulation and were not prone to somnambulism or repetitive involuntary motor behaviors. It, therefore, seems highly unlikely that all patients could have manipulated the device in exactly the same way to result in the same postrotational position within the implant pocket. The fact is that the same device was implicated in all these cases in a relatively similar time sequence from implant to recognition of the implantable cardiac defibrillator rotation. We postulate that the unique elongated decision of the Fortify Assura (St. Jude Medical, Minneapolis, MN, USA) ICD makes this device prone to spontaneous rotation as is exemplified by our case series.

Active fixation of a thin transvenous left-ventricular lead by a side helix facilitates targeted and stable placement in cardiac resynchronization therapy.

AIMS: Suboptimal placement, phrenic nerve stimulation, and dislodgements of left-ventricular (LV) leads are main challenges in cardiac resynchronization therapy. We investigated the handling, performance, safety, and stability for a novel 4Fr LV lead with a small side helix located proximal to the ring electrode for active fixation of the LV lead. METHODS AND RESULTS: The novel LV lead was successfully implanted in 103 of 106 patients. Patients with dislodged LV leads and with demanding coronary vein anatomies were included. The lead body was rotated clockwise to engage the active fixation side helix in the vein wall. The stimulating electrode was located in basal LV segment and middle LV segment in 54 and 46% of the patients, respectively. The lead was targeted to a vein concordant to the LV segment with latest mechanical activation. Concordant LV lead placement was achieved in 73% of the patients and in adjacent segment in 24%. The average pacing capture threshold (PCT) at implantation was 1.04 ± 0.6 V (n = 103) and at an average follow-up at 7 months, the PCT remained low and no dislodgements have been observed. During follow-up, four leads have been explanted without complications. CONCLUSION: Active fixation of this 4Fr LV lead by using a side helix, offers flexibility to place the lead precisely in targeted vein segments over a wide range of vein anatomies. The average LV pacing threshold was low at implantation and follow-ups. The lead seems to be extractable and no late dislodgements have been observed.

Use of a novel pacing mode to achieve biventricular pacing in a patient with recurrent atrial lead dislodgement after CRT-D implantation.

Cardiac resynchronization therapy device (CRT-P and CRT-D) implantation has increased tremendously with increasing operator experience, eligible patients and expansion of indications. Refinements in devices and algorithms now aid physicians to improve biventricular pacing and optimize CRT. We report a case in which an interesting device program was used to achieve biventricular pacing after repeated dislodgement of the atrial lead in a patient implanted with CRT-D.