Persistent left superior vena cava transvenous lead extraction: A European experience.

BACKGROUND: Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare. METHOD: Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported. RESULTS: Ten patients aged 73.4 ± 7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95 ± 39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4 ± 74.7 min. There was no 30-day mortality. CONCLUSION: TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.

Leadless pacemaker implant in patients with pre-existing infections: Results from the Micra postapproval registry.

INTRODUCTION: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. METHODS AND RESULTS: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT-D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow-up duration was 8.5 ± 7.1 months (range 0-28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1-7). During follow-up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. CONCLUSION: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

Metal artefact reduction algorithms prevent false positive results when assessing patients for cardiac implantable electronic device infection.

Software-based metal artefact reduction (MAR) techniques are available to reduce artefacts from cardiac implantable electronic devices (CIED) in the CT data. The impact of disabling MAR techniques on quantification of 18F-FDG uptake around the CIED has not been examined. We consider the importance of enabling MAR in patients with suspected CIED infection to prevent inaccuracies in quantification of tissue tracer uptake on the attenuation-corrected PET images.

Increased late complex device infections are determined by cardiac resynchronization therapy-defibrillator infection.

AIMS: The incidence of cardiac device infection (CDI) more than 12 months following complex device implant (late infection) has not been extensively reported. Our objective was to compare both early (within 12 months) and late infection rates following complex device implantation. METHODS AND RESULTS: Patients who received either a cardiac resynchronization therapy (CRT) device with or without a defibrillator (CRT-D or CRT-P), or a defibrillator alone [implantable cardioverter-defibrillator (ICD)], between March 2005 and December 2011 were studied retrospectively. The study endpoint was device removal due to CDI. A total of 496 patients underwent complex device implantation. There were 1883 patient years of follow-up. Mean age was 73 ± 8 years. Seventy per cent were male. Overall, 24 infections (4.8%) were identified; 6 infections were within 12 months (1.2%) and 18 (3.7%) infections at least 12 months following implant (P < 0.025). The mean intervals between implant and infection were 6 months (±3.7) and 30 months (±14.4) in the early and late groups, respectively. Early infection rates (%) for ICD, CRT-P, and CRT-D devices were 1.5, 1.6, and 0.6, respectively. Corresponding late infection rates were 2.2, 2.1, and 6.4. The increased late infection rate was driven by increased CRT-D infection (P < 0.01; compared with early CRT-D infection). CONCLUSION: Early CDI rates are consistent with published data. Compared with early infection, late CDI rates are significantly increased and are due to CRT-D infection. These findings are consistent with emerging reports. Late CRT-D infection threatens to undermine the long-term costs and overall health gain from these devices.

Pacing-induced cardiomyopathy: pathophysiological insights through matrix metalloproteinases.

Pacing-induced ventricular dysfunction and pacing-induced cardiomyopathy (PiCMP) are recognized complications of chronic right ventricular pacing. Alterations in myocardial perfusion and sympathetic innervation contribute to the development of pacing-induced heart disease. However, it is unlikely that these are the only processes involved. Matrix metalloproteinases (MMPs) are proteolytic enzymes that degrade the collagenous extracellular matrix and play a central role in left ventricular remodelling during the development of heart failure. While the pathophysiological mechanisms and altered MMP expression that occur in chronic pressure overload, ischaemic and non-ischaemic dilated cardiomyopathy have been defined, those that occur in the clinical setting of pacing-induced ventricular dysfunction and PiCMP have not been reported. Here we review the clinical epidemiology of pacing-induced ventricular dysfunction and discuss how data derived from animal models provide insight into how changes in MMP expression and function contribute to the development of PiCMP. The review concludes by exploring pacing strategies that may be used to prevent pacing-induced ventricular dysfunction.

Patient radiation dose during fluoroscopically guided biventricular device implantation.

OBJECTIVE: Implantation of biventricular devices (BiV) with a transvenous left ventricular lead is complex requiring a significant fluoroscopy time and radiation dose. In the United Kingdom, the Health Protection Agency (HPA) collects data regarding radiographic procedures and sets national diagnostic reference levels (DRL) at the 75th percentile of the distribution of doses for a wide range of procedures. Insufficient data were returned to the HPA to allow them to set DRL for BiV devices at the last publication in 2010. Due to the large variation in data available and small datasets for BiV procedures we aimed to collect a large dataset to guide standards for implantation. METHODS: We collected retrospective data (fluoroscopy time and radiation dose [DAP]) for new BiV devices for the three years 2009-2011 from three high volume tertiary centres in the North West of England. Databases were scrutinised to ensure the quality of the data. RESULTS: From a total of 1374 implants we identified data for 1319 patients for fluoroscopy time and 1316 for DAP. The mean fluoroscopy time for all three centres combined was 18.7±0.3 min. The 75th percentile fluoroscopy time for the combined data was 24.2 min. The mean DAP for the three centres combined was 25.1±1.3 Gy cm2. The 75th percentile DAP for the combined data was 27.7 Gy cm2. CONCLUSIONS: We present a large dataset of new biventricular device implants, based on the 75th percentile data we suggest a DRL of 24.2 min and 27.7 Gy cm2.

Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial.

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.

Advantages of a subcutaneous implantable cardioverter-defibrillator in LAMP2 hypertrophic cardiomyopathy.

Danon disease is a rare X-linked lysosomal disease causing severe hypertrophic cardiomyopathy (LAMP2 cardiomyopathy) and an extremely poor prognosis in males, with several reported cases of sudden cardiac death despite the use of transvenous implantable cardioverter defibrillators (TV-ICD). We describe a case in which a TV-ICD was unable to defibrillate induced ventricular fibrillation (VF), but a wholly subcutaneous system (S-ICD) was successful in terminating induced VF and spontaneous ventricular tachycardia. These findings have relevance to the selection of device therapy in the management of these individuals and a wider group of young patients with severe hypertrophic cardiomyopathy.

Not all pacemakers are created equal: MRI conditional pacemaker and lead technology.

Due to expanding clinical indications and an aging society there has been an increase in the use of implantable pacemakers. At the same time, due to increased diagnostic yield over other imaging modalities and the absence of ionizing radiation, there has been a surge in demand for magnetic resonance imaging (MRI) assessment, of both cardiac and noncardiac conditions. Patients with an implantable device have a 50-75% chance of having a clinical indication for MRI during the lifetime of their device. The presence of an implantable cardiac device has been seen as a relative contraindication to MRI assessment, limiting the prognostic and diagnostic utility of MRI in many patients with these devices. The introduction of MRI conditional pacemakers will enable more patients to undergo routine MRI assessment without risk of morbidity or device malfunction. This review gives a general overview of the principles and current evidence for the use of MRI conditional implantable cardiac devices. Furthermore, we appraise the differences between those pacemakers currently released to market.

Interaction between Cfd1 and Nbp35 proteins involved in cytosolic FeS cluster assembly machinery deciphers a stable complexation in Leishmania donovani.

Leishmania donovani is the causative unicellular parasite for visceral leishmaniasis (VL); and FeS proteins are likely to be very essential for their survival and viability. Cytosolic FeS cluster assembly (CIA) machinery is one of the four systems for the biosynthesis and transfer of FeS clusters among eukaryotes; Cfd1 and Nbp35 are the scaffold components for cytosolic FeS cluster biogenesis. We investigated the role of CIA machinery components and purified Cfd1 and Nbp35 proteins of L. donovani. We also investigated the interactive nature between LdCfd1 and LdNbp35 proteins by in silico analysis, in vitro co-purification, pull down assays along with in vivo immuno-precipitation; which inferred that both LdCfd1 and LdNbp35 proteins are interacting with each other. Thus, our collective data revealed the interaction between these two proteins which forms a stable complex that can be attributed to the cellular process of FeS clusters biogenesis, and transfer to target apo-proteins of L. donovani. The expression of Cfd1 and Nbp35 proteins in Amp B resistant parasites is up-regulated leading to increased amount of FeS proteins. Hence, it favors increased tolerance towards ROS level, which helps parasites survival under drug pressure contributing in Amphotericin B resistance.

UK Expert Consensus Statement for the Optimal Use and Clinical Utility of Leadless Pacing Systems on Behalf of the British Heart Rhythm Society.

Pacemakers are a key technology in the treatment of bradyarrhythmias. Leadless pacemakers (LP) were introduced to address limitations of transvenous devices. However, guidelines and other restrictions have led to LPs becoming niche products. The aim of this consensus statement was to determine the strength of opinion of UK implantation experts as to how LPs can be more optimally used. Using a modified Delphi approach, a panel of LP experts developed 36 statements that were used to form a survey that was distributed to LP implanters in the UK. Stopping criteria included a 3-month window for response, a minimum 25% response rate and at least 75% of statements achieving the threshold for consensus (agreed at 66%). In all, 31 of 36 statements reached consensus, and 23 of these achieved ≥90% agreement. Five statements did not achieve consensus. On the basis of these results, seven recommendations were proposed. The implementation of these recommendations may increase the use of LPs, with the aim of improving patient outcomes.

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study.

AIMS: The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. METHODS AND RESULTS: COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72-88%] than the previous 12 months (0.27 vs. 1.52 events/patient-year, respectively, P < 0.0001). Freedom from device/system-related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. CONCLUSIONS: Remote haemodynamic-guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.

An Unusual Cause of Pacemaker Lead Displacement: 'Reverse Ratchet' Syndrome.

Lead displacement is a common complication of pacemaker device implantation, often resulting in prolonged hospital stays and increased costs. The frequency of long-term lead displacement ranges between 1.8% and 8.0%. In our case, the patient did not present any symptoms and the lead displacement was seen at a relatively late stage. During a routine pacemaker follow up, it was noted that the right ventricular (RV) threshold had increased and deteriorated over time. The pacemaker box had rotated anticlockwise and the RV lead had developed a loop that eventually led to its retraction from the RV implantation position into the pulmonary artery. The patient was asymptomatic; however, he underwent RV lead revision. Patient education, opening an appropriate pocket for the size of the generator, fixing the sleeves to an appropriate tightness and securing the battery with a strong suture all can be used to avoid lead displacement.

Novel atrioventricular sequential pacing approach using a transvenous atrial pacemaker and a leadless pacemaker: a case report.

BACKGROUND: The use of transvenous pacing leads is associated with the risk of developing tricuspid valve (TV) dysfunction. This develops through several mechanisms including the failure of leaflet coaptation or direct damage to the TV or to its sub-valvular apparatus and can result in significant tricuspid regurgitation (TR). Multiple approaches to pacemaker implantation after transvenous lead extraction (TLE) or surgical TV repair have been described. Placement of pacing leads across the TV is generally avoided in such circumstances. CASE SUMMARY: A 66-year-old woman presented with a year-long history of exertional dyspnoea, peripheral oedema, and postural neck pulsations. Her medical history included a dual-chamber pacemaker implantation for sinus node dysfunction 14 years ago. Echocardiography revealed severe lead-related TR. Her case was discussed in our multi-disciplinary team meeting. A decision was made to perform a TLE and implant a leadless pacemaker in an attempt to avoid open-heart surgery if possible. This was reserved as an option in the event of persistent severe TR. Transvenous extraction of the right ventricular lead was performed. The atrial lead was preserved and connected to and AAI device. A Micra AV was implanted allowing for atrioventricular (AV) synchronous pacing. DISCUSSION: We present the first case of successful implementation of AV sequential pacing using a dual-pacemaker approach involving the use of an AAI pacemaker and a Micra AV device. This was performed after TLE for severe lead-related TR.

Ambulatory intravenous furosemide for decompensated heart failure: safe, feasible, and effective.

AIMS: This study aims to establish the feasibility, safety, and efficacy of outpatient intravenous (IV) diuretic treatment for the management of decompensated heart failure (HF) for patients enrolled in the HeartFailure@Home service. METHODS AND RESULTS: We retrospectively analysed the clinical episodes of decompensated HF for patients enrolled in the HeartFailure@Home service, managed by ambulatory IV diuretic treatment either at home or on a day-case unit. A control group consisting of HF patients admitted to hospital for IV diuretics (standard-of-care) was also evaluated. In total, 203 episodes of decompensated HF (n = 154 patients) were evaluated. One hundred and fourteen episodes in 79 patients were managed exclusively by the ambulatory IV diuretic service-78 (68.4%) on a day-case unit and 36 (31.6%) domiciliary; 84.1% of patient episodes under the HF@Home service were successfully managed entirely in an out-patient setting without hospitalization. Eleven patients required admission in order to administer higher doses of IV diuretics than could be provided in the ambulatory setting. During follow-up, there were 20 (17.5%) 30 day re-admissions with HF or death in the ambulatory IV group and 29 (32.6%) in the standard-of-care arm (P = 0.02). There was no difference in 30 day HF readmissions between the two groups (14.9% ambulatory vs. 13.5% inpatients, P = 0.8), but 30 day mortality was significantly lower in the ambulatory group (3.5% vs. 21.3% inpatients, P < 0.001). CONCLUSIONS: Outpatient ambulatory management of decompensated HF with IV diuretics given either on a day case unit or in a domiciliary setting is feasible, safe, and effective in selected patients with decompensated HF. This should be explored further as a model in delivering HF services in the outpatient setting during COVID-19.

Performance of first pacemaker to use smart device app for remote monitoring.

BACKGROUND: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. OBJECTIVE: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods. METHODS: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless). RESULTS: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber). CONCLUSION: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM.

Triage-HF Plus: a novel device-based remote monitoring pathway to identify worsening heart failure.

AIMS: Remote monitoring of patients with physiological data derived from cardiac implanted electronic devices (CIEDs) offers potential to reconfigure clinical services. The 'Heart Failure Risk Score' (HFRS) uses input from integrated device physiological monitoring to risk-stratify patients as low-risk, medium-risk, or high-risk of a heart failure event in the next 30 days. This study aimed to evaluate a novel clinical pathway utilizing a combination of CIED risk-stratification and telephone triage to identify patients with worsening heart failure (WHF). METHODS AND RESULTS: A prospective, single-centre, real-world evaluation of the 'Triage-HF Plus' clinical pathway (HFRS in combination with telephone triage) over a 27 month period. One hundred and fifty-seven high-risk HFRS transmissions were referred for telephone triage assessment. Interventions were at the discretion of the clinical assessor acting in accordance with clinical guidelines. An additional 3month consecutive sample of low and medium HFRS transmissions (control group) were also contacted for telephone triage assessment (n = 98). Successful telephone contact was made in 127 (81%) of referred high-risk HFRS cases: 71 (55.9%) were confirmed to have WHF requiring intervention; 19 (14.9%) had an alternative acute medical problem; one patient had been recently discharged from hospital with WHF; and 36 (28.0%) had no apparent cause for the high score. In the control group, only one patient had symptoms of WHF. The sensitivity and specificity of CIED-based remote monitoring to identify WHF 98.6% (92.5-100.0%) and 63.4% (55.2-71.0%), respectively. CONCLUSIONS: The Triage-HF Plus clinical pathway is a potentially useful remote monitoring tool for patients with heart failure and in situ CIEDs.

Correction: Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study.

[This corrects the article DOI: 10.1371/journal.pone.0206611.].