124 results on '"Mark M Gallagher"'
Search Results
2. Real-world results of oesophageal protection from a temperature control device during left atrial ablation
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Lisa W M Leung, Pavandeep Toor, Zaki Akhtar, Abhay Bajpai, Anthony Li, Manav Sohal, and Mark M Gallagher
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
3. Triple access transvenous lead extraction: Pull‐through of a lead from subclavian to jugular access to facilitate extraction
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Zaki Akhtar, Khiast Ullah Zaman, Lisa WM Leung, Zia Zuberi, Manav Sohal, and Mark M. Gallagher
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General Medicine ,Cardiology and Cardiovascular Medicine - Published
- 2022
4. Anatomical variations in coronary venous drainage: Challenges and solutions in delivering cardiac resynchronization therapy
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Zaki Akhtar, Manav Sohal, Christos Kontogiannis, Idris Harding, Zia Zuberi, Abhay Bajpai, Mark Norman, Simon Pearse, Ian Beeton, and Mark M. Gallagher
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Cardiac Resynchronization Therapy ,Heart Failure ,Male ,Vena Cava, Superior ,Persistent Left Superior Vena Cava ,Vascular Malformations ,Physiology (medical) ,Drainage ,Humans ,Female ,Cardiac Resynchronization Therapy Devices ,Cardiology and Cardiovascular Medicine - Abstract
Aims\ud To investigate the abnormalities of the coronary venous system in candidates for cardiac resynchronization therapy (CRT) and describe methods for circumventing the resulting difficulties.\ud \ud Methods\ud From four implanting institutes, data of all CRT implants between October 2008 and October 2020 were screened for abnormal cardiac venous anatomy, defined as an anatomical variation not conforming to the accepted ‘normal’ anatomy. Patient demographics, procedural detail, and subsequent left ventricle (LV) lead pacing indices were collected.\ud \ud Results\ud From a total of 3548 CRT implants, 15 (0.42%) patients (80% male) of 72.2 ± 10.6 years in age with an LV ejection fraction of 34 ± 10.3% were identified to have had an abnormal cardiac venous anatomy over the study period. There were 13 cases of persistent left side superior vena cava (pLSVC), five of which had coronary sinus ostium atresia (CSOA) including two with an “unroofed” coronary sinus (CS); one patient had a unique anomalous origin of the CS and one patient had an isolated CSOA. In total 14 patients (60% repeat attempt) had successful percutaneous implant under general anesthesia (46.7%) via the cephalic vein (59.1%), using the femoral approach (53.3%) for levophase venography and/or pull-through, including one case of endocardial LV implant. Pacing follow-up over 37.64 ± 37.6 months demonstrated LV lead threshold between 0.62 and 2.9 volts (pulsewidth 0.4–1.5 ms) in all cases; five patients died within 2.92 ± 1.6 years of a successful implant.\ud \ud Conclusion\ud CRT devices can be implanted percutaneously even in the presence of substantial abnormalities of coronary venous anatomy. Alternative routes of venous access may be required.
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- 2022
5. Hourly variability in outflow tract ectopy as a predictor of its site of origin
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Manav Sohal, Gareth R Thomas, Mark M Gallagher, Lisa W. Leung, Benedict M. Wiles, Magdi Saba, Michael C. Waight, Anthony Li, Elijah R. Behr, and Alejandro Jimenez Restrepo
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Patient Consent ,medicine.medical_specialty ,Radiofrequency ablation ,Heart Ventricles ,Coefficient of variation ,Youden's J statistic ,law.invention ,Electrocardiography ,law ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,Ventricular ectopic ,Retrospective Studies ,Site of origin ,business.industry ,medicine.disease ,Ventricular Premature Complexes ,Bigeminy ,Ambulatory ,Catheter Ablation ,Tachycardia, Ventricular ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
INTRODUCTION Before ablation, predicting the site of origin (SOO) of outflow tract ventricular arrhythmia (OTVA), can inform patient consent and facilitate appropriate procedural planning. We set out to determine if OTVA variability can accurately predict SOO. METHODS Consecutive patients with a clear SOO identified at OTVA ablation had their prior 24-h ambulatory ECGs retrospectively analysed (derivation cohort). Percentage ventricular ectopic (VE) burden, hourly VE values, episodes of trigeminy/bigeminy, and the variability in these parameters were evaluated for their ability to distinguish right from left-sided SOO. Effective parameters were then prospectively tested on a validation cohort of consecutive patients undergoing their first OTVA ablation. RESULTS High VE variability (coefficient of variation ≥0.7) and the presence of any hour with
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- 2021
6. Persistent left superior vena cava transvenous lead extraction: A European experience
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Mark M Gallagher, Alexander Breitenstein, Patrizio Mazzone, Jan Steffel, Christoph Starck, Manav Sohal, Elkin Gonzalez, Zaki Akhtar, Sergio Richter, Amir Zaidi, Omar Al-Razzo, Christopher A. Rinaldi, Francesco Melillo, Zia Zuberi, Vishal Mehta, University of Zurich, and Akhtar, Zaki
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Male ,Pacemaker, Artificial ,medicine.medical_specialty ,Vena Cava, Superior ,610 Medicine & health ,2705 Cardiology and Cardiovascular Medicine ,2737 Physiology (medical) ,Persistent Left Superior Vena Cava ,Superior vena cava ,Physiology (medical) ,medicine ,Humans ,General anaesthesia ,Persistent left superior vena cava ,Device Removal ,Aged ,Aged, 80 and over ,business.industry ,Healthy population ,medicine.disease ,Defibrillators, Implantable ,Transvenous lead ,Surgery ,Treatment Outcome ,medicine.anatomical_structure ,Ventricle ,10209 Clinic for Cardiology ,Right atrium ,Female ,Cardiology and Cardiovascular Medicine ,business ,Lead extraction - Abstract
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.
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- 2021
7. Delays in AF ablation cost lives
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Lisa W. M. Leung, Pavandeep Toor, Zaki Akhtar, and Mark M. Gallagher
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
8. Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort
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Jan Steffel, Christoph Starck, Zaki Akhtar, Pia Lanmüller, Lisa W M Leung, Manav Sohal, Alexander Breitenstein, Elkin Gonzalez, Jürgen Eulert-Grehn, Mark M Gallagher, Giulia Domenichini, Ahmed I Elbatran, Patrizio Mazzone, Alessandra Marzi, Peter-Paul Delnoy, Omar Al-Razzo, and Francesco Melillo
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Adult ,Male ,medicine.medical_specialty ,Multivariate analysis ,Population ,Older patients ,Internal medicine ,Humans ,Medicine ,Major complication ,Risk factor ,education ,Device Removal ,Aged ,Retrospective Studies ,Aged, 80 and over ,education.field_of_study ,business.industry ,Age Factors ,General Medicine ,Middle Aged ,Electrodes, Implanted ,Transvenous lead ,Europe ,Propensity score matching ,Cohort ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
BACKGROUND Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. METHODS Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [
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- 2021
9. Prevalence of bradyarrhythmias needing pacing in COVID‐19
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Zia Zuberi, Sumeet Sharma, Lisa Wm Leung, Abhay Bajpai, Mark M Gallagher, Christos Kontogiannis, Manav Sohal, Ian Beeton, Zaki Akhtar, and Zhong Chen
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Male ,Bradycardia ,medicine.medical_specialty ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Sepsis ,COVID‐19 ,Internal medicine ,Devices ,Prevalence ,medicine ,Humans ,In patient ,high‐degree AV block ,Aged ,Aged, 80 and over ,pacing ,business.industry ,Cardiac Pacing, Artificial ,COVID-19 ,General Medicine ,medicine.disease ,Cohort ,Cardiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background The Sars-Cov-2 infection is a multisystem illness that can affect the cardiovascular system. Tachyarrhythmias have been reported but the prevalence of bradyarrhythmia is unclear. Cases have been described of transient high-degree atrioventricular (AV) block in COVID-19 that were managed conservatively. Method A database of all patients requiring temporary or permanent pacing in 2 linked cardiac centres was used to compare the number of procedures required during the first year of the pandemic compared to the corresponding period a year earlier. The database was cross-referenced with a database of all patients testing positive for Sars-Cov-2 infection in both institutions to identify patients who required temporary or permanent pacing during COVID-19. Results The number of novel pacemaker implants was lower during the COVID-19 pandemic than the same period the previous year (540 vs 629, respectively), with a similar proportion of high-degree AV block (38.3% vs 33.2%, respectively, p = 0.069). Four patients with the Sars-Cov-2 infection had a pacemaker implanted for high-degree AV block, 2 for sinus node dysfunction. Of this cohort of six patients, two succumbed to the COVID-19 illness and one from non-COVID sepsis. Device interrogation demonstrated a sustained pacing requirement in all cases. Conclusion High-degree AV block remained unaltered in prevalence during the COVID-19 pandemic. There was no evidence of transient high-degree AV block in patients with the Sars-Cov-2 infection. Our experience suggests that all clinically significant bradyarrhythmia should be treated by pacing according to usual protocols regardless of the COVID status. This article is protected by copyright. All rights reserved.
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- 2021
10. Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes
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Lisa W M, Leung, Zaki, Akhtar, Ahmed I, Elbatran, Abhay, Bajpai, Anthony, Li, Mark, Norman, Riyaz, Kaba, Manav, Sohal, Zia, Zuberi, and Mark M, Gallagher
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Treatment Outcome ,Pulmonary Veins ,Recurrence ,Physiology (medical) ,Atrial Fibrillation ,Catheter Ablation ,Humans ,Heart Atria ,Cardiology and Cardiovascular Medicine - Abstract
The IMPACT study established the role of controlled esophageal cooling in preventing esophageal thermal injury during radiofrequency (RF) ablation for atrial fibrillation (AF). The effect of esophageal cooling on ablation lesion delivery and procedural and patient outcomes had not been previously studied. The objective was to determine the effect of esophageal cooling on the formation of RF lesions, the ability to achieve procedural endpoints, and clinical outcomes.Participants in the IMPACT trial underwent AF ablation guided by Ablation Index (30 W at 350-400 AI posteriorly, 40 W at ≥450 AI anteriorly). A blinded 1:1 randomization assigned patients to the use of the ensoETM® device to keep esophageal temperature at 4°C during ablation or standard practice using a single-sensor temperature probe. Ablation parameters and clinical outcomes were analyzed.Procedural data from 188 patients were analyzed. Procedure and fluoroscopy times were similar, and all pulmonary veins were isolated. First-pass pulmonary vein isolation and reconnection at the end of the waiting period were similar in both randomized groups (51/64 vs. 51/68; p = 0.54 and 5/64 vs. 7/68; p = 0.76, respectively). Posterior wall isolation was also similar: 24/33 versus 27/38; p = 0.88. Ablation effect on tissue, measured in impedance drop, was no different between the two randomized groups: 8.6Ω (IQR: 6-11.8) versus 8.76Ω (IQR: 6-12.2; p = 0.25). Arrhythmia recurrence was similar after 12 months (21.1% vs. 24.1%; 95% CI: 0.38-1.84; HR: 0.83; p = 0.66).Esophageal cooling has been shown to be effective in reducing ablation-related thermal injury during RF ablation. This protection does not compromise standard procedural endpoints or clinical success at 12 months.
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- 2022
11. Multi‐lead cephalic venous access and long‐term performance of high‐voltage leads
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Oswaldo Valencia, Lisa W M Leung, Manav Sohal, Andrew T Cox, Ian Beeton, Mark M Gallagher, Zia Zuberi, Nilanka Mannakkara, Idris Harding, Zaki Akhtar, Fadi Jouhra, Simon Pearse, Anthony Li, Zhong Chen, Ahmed I Elbatran, Abhay Bajpai, and Hanney Gonna
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Icd lead ,030204 cardiovascular system & hematology ,Cardiac Resynchronization Therapy ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,Internal medicine ,Lead failure ,Humans ,Medicine ,Cardiac Resynchronization Therapy Devices ,030212 general & internal medicine ,Lead (electronics) ,Heart Failure ,Cephalic vein ,business.industry ,Implantable cardioverter-defibrillator ,Defibrillators, Implantable ,Venous access ,Treatment Outcome ,Hypertension ,Cohort ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Body mass index - Abstract
Background Cardiac resynchronization therapy-defibrillator (CRT-D) implantation via the cephalic vein is feasible and safe. Recent evidence has suggested a higher implantable cardioverter-defibrillator (ICD) lead failure in multi-lead defibrillator therapy via the cephalic route. We evaluated the relationship between CRT-D implantation via the cephalic and ICD lead failure. Methods Data was collected from three CRT-D implanting centers between October 2008 and September 2017. In total 633 patients were included. Patient and lead characteristics with ICD lead failure were recorded. Comparison of "cephalic" (ICD lead via cephalic) versus "non-cephalic" (ICD lead via non-cephalic route) cohorts was performed. Kaplan-Meier survival and a Cox-regression analysis were applied to assess variables associated with lead failure. Results The cephalic and non-cephalic cohorts were equally male (81.9% vs. 78%; p = .26), similar in age (69.7 ± 11.5 vs. 68.7 ± 11.9; p = .33) and body mass index (BMI) (27.7 ± 5.1 vs. 27.1 ± 5.7; p = .33). Most ICD leads were implanted via the cephalic vein (73.5%) and patients had a mean of 2.9 ± 0.28 leads implanted via this route. The rate of ICD lead failure was low and statistically similar between both groups (0.36%/year vs. 0.13%/year; p = .12). Female gender was more common in the lead failure cohort than non-failure (55.6% vs. 17.9%, respectively; p = .004) as was hypertension (88.9% vs. 54.2%, respectively, p = .038). On multivariate Cox-regression, female sex (p = .008; HR, 7.12 [1.7-30.2]), and BMI (p = .047; HR, 1.12 [1.001-1.24]) were significantly associated with ICD lead failure. Conclusion CRT-D implantation via the cephalic route is not significantly associated with premature ICD lead failure. Female gender and BMI are predictors of lead failure.
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- 2021
12. Stridor and dyspnoea after ablation for atrial fibrillation
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Khalid Bin Waleed, Pavandeep Toor, Zaki Akhtar, Jonathan Aron, Paul Govewalla, and Mark M Gallagher
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
13. Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study
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Mark M Gallagher, Manav Sohal, Riyaz Kaba, Zaki Akhtar, Zia Zuberi, Hanney Gonna, Abhay Bajpai, Lisa W M Leung, Idris Harding, John Louis-Auguste, Jamal Hayat, Nawaf Al-Subaie, Banu Evranos, Mark Norman, and Anthony Li
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Gastroparesis ,Randomization ,medicine.medical_treatment ,Catheter ablation ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,Esophagus ,0302 clinical medicine ,Randomized controlled trial ,Clinical Research ,law ,Physiology (medical) ,medicine ,Humans ,AcademicSubjects/MED00200 ,General anaesthesia ,Prospective Studies ,030212 general & internal medicine ,Temperature control ,Thermal injury ,business.industry ,Temperature ,Atrial fibrillation ,Ablation ,medicine.disease ,Ablation for Atrial Fibrillation ,Oesophagus ,Treatment Outcome ,Anesthesia ,Catheter Ablation ,Atrio-oesophageal fistula ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims Thermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury. Methods and results A single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27). There was no difference between groups in the duration of RF or in the force applied (P value range= 0.2–0.9). Procedure duration and fluoroscopy duration were similar (P = 0.97, P = 0.91, respectively). Conclusion Thermal protection of the oesophagus significantly reduces ablation-related thermal injury compared with standard care. This method of oesophageal protection is safe and does not compromise the efficacy or efficiency of the ablation procedure.
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- 2020
14. CARDIAC RHYTHM MANAGEMENTPredictors and management of cardiac perforation caused by cardiac rhythm device implantation
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Ahmed I Elbatran, Alexander Grimster, Anthony Li, Abhay Bajpai, and Mark M Gallagher
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medicine.medical_specialty ,business.industry ,Diastole ,medicine.disease ,Pericardial effusion ,law.invention ,Rhythm ,law ,Cardiac Perforation ,Diabetes mellitus ,Heart failure ,Internal medicine ,medicine ,Cardiology ,Artificial cardiac pacemaker ,Systole ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Cardiac perforation caused by cardiac rhythm device implantation is uncommon but potentially lethal. Methods All patients presenting to a single referral centre with cardiac perforation after implantation between December 2017 and July 2019 were identified. Patient demographics, time to diagnosis, the method of lead extraction and 30-day complications were examined. Results Thirteen cases of cardiac perforation were identified, 4 of which were implanted at other hospitals. The incidence of perforation for devices implanted at our institution was 9/1031 (0.87%). Median time from implantation to diagnosis was 8 days (IQR = 3–21). Compared with implantations during the same time period, patients with perforation were older (80 ± 10 years vs. 73 ± 15 years, P = 0.005) and predominantly females (9/13 vs. 355/1031, P = 0.009). In all cases, the perforating lead was an active fixation model, an ICD coil in one case. 10 leads were in the right ventricle (3 of which in apical position) and 3 in the right atrium (all in the lateral wall). There was no greater proportion of a particular lead type compared with implantations during the same time period. All had abnormal electrical parameters at device interrogation. Nine patients (69%) had pericardial effusion and four (31%) developed tamponade. Transvenous lead extraction was successfully performed in all 13 patients, with no 30-day mortality. Conclusion Older age and female gender were more prevalent in patients with lead perforation. Transvenous lead extraction was safely performed in all patients.
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- 2020
15. Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions
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Zaki Akhtar, Mark M. Gallagher, Ahmed I. Elbatran, Christoph T. Starck, Elkin Gonzalez, Omar Al‐Razzo, Patrizio Mazzone, Peter‐Paul Delnoy, Alexander Breitenstein, Jan Steffel, Jürgen Eulert‐Grehn, Pia Lanmüller, Francesco Melillo, Alessandra Marzi, Lisa WM Leung, Giulia Domenichini, Manav Sohal, University of Zurich, and Akhtar, Zaki
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Pacemaker, Artificial ,Treatment Outcome ,10209 Clinic for Cardiology ,Humans ,610 Medicine & health ,General Medicine ,Cardiology and Cardiovascular Medicine ,Promethazine ,2705 Cardiology and Cardiovascular Medicine ,Device Removal ,Defibrillators, Implantable ,Retrospective Studies - Abstract
With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce.We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units.Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality.CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p .001) and with pre-dominantly non-infectious indications (57.4% vs. 50.2%, CS vs. cardiologists, p .001). CS achieved a higher complete success per lead than the cardiologists (98.1% vs. 95.7%, respectively, p .01), with a higher number of minor complications (5.51% vs. 2.1%, p .01) and similar number of major complications (0.47% vs. 1.3%, p = .12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs. 0.94%, p = .21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p .01), procedure duration (OR 1.01 [1.01-1.02], p .01) and CS operator (OR 2.67, [1.12-6.37], p = .027) were associated with 30-day mortality.TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.
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- 2022
16. Cost-effectiveness of catheter ablation versus medical therapy for the treatment of atrial fibrillation in the United Kingdom
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Lisa W. M. Leung, Ryan J. Imhoff, Howard J. Marshall, Diana Frame, Peter J. Mallow, Laura Goldstein, Tom Wei, Maria Velleca, Hannah Taylor, and Mark M. Gallagher
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Physiology (medical) ,Cost-Benefit Analysis ,Atrial Fibrillation ,Catheter Ablation ,Humans ,Cardiology and Cardiovascular Medicine ,Anti-Arrhythmia Agents ,Markov Chains ,State Medicine ,United Kingdom ,health care economics and organizations - Abstract
INTRODUCTION: Research evidence has shown that catheter ablation is a safe and superior treatment for atrial fibrillation (AF) compared to medical therapy, but real-world practice has been slow to adopt an early interventional approach. This study aims to determine the cost effectiveness of catheter ablation compared to medical therapy from the perspective of the United Kingdom. METHODS: A patient-level Markov health-state transition model was used to conduct a cost-utility analysis. The population included patients previously treated for AF with medical therapy, including those with heart failure (HF), simulated over a lifetime horizon. Data sources included published literature on utilization and cardiovascular event rates in real world patients, a systematic literature review and meta-analysis of randomized controlled trials for AF recurrence, and publicly available government data/reports on costs. RESULTS: Catheter ablation resulted in a favorable incremental cost-effectiveness ratio (ICER) of £8614 per additional quality adjusted life years (QALY) gained when compared to medical therapy. More patients in the medical therapy group failed rhythm control at any point compared to catheter ablation (72% vs. 24%) and at a faster rate (median time to treatment failure: 3.8 vs. 10 years). Additionally, catheter ablation was estimated to be more cost-effective in patients with AF and HF (ICER = £6438) and remained cost-effective over all tested time horizons (10, 15, and 20 years), with the ICER ranging from £9047-£15 737 per QALY gained. CONCLUSION: Catheter ablation is a cost-effective treatment for atrial fibrillation, compared to medical therapy, from the perspective of the UK National Health Service.
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- 2022
17. Arrhythmias in Chronic Kidney Disease
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Zaki Akhtar, Lisa WM Leung, Christos Kontogiannis, Isaac Chung, Khalid Bin Waleed, and Mark M Gallagher
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cardiovascular system ,cardiovascular diseases ,urologic and male genital diseases ,Cardiology and Cardiovascular Medicine - Abstract
Arrhythmias cause disability and an increased risk of premature death in the general population but far more so in patients with renal failure. The association between the cardiac and renal systems is complex and derives in part from common causality of renal and myocardial injury from conditions including hypertension and diabetes. In many cases, there is a causal relationship, with renal dysfunction promoting arrhythmias and arrhythmias exacerbating renal dysfunction. In this review, the authors expand on the challenges faced by cardiologists in treating common and uncommon arrhythmias in patients with renal failure using pharmacological interventions, ablation and cardiac implantable device therapies. They explore the most important interactions between heart rhythm disorders and renal dysfunction while evaluating the ways in which the coexistence of renal dysfunction and cardiac arrhythmia influences the management of both.
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- 2022
18. Impact of ablation index settings on pulmonary vein reconnection
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Mark M Gallagher, S Abbey, Matteo Anselmino, M. Rillo, Frederic Sebag, Francesco Solimene, Ennio Pisano, Graziana Viola, Domenico Pecora, F. Lamberti, Giuseppe Sgarito, Marco Scaglione, A. Lepillier, A. De Simone, E. De Ruvo, Emanuele Bertaglia, A. Pani, Teresa Strisciuglio, Giulio Zucchelli, Giuseppe Stabile, Lepillier, A., Strisciuglio, T., De Ruvo, E., Scaglione, M., Anselmino, M., Sebag, F. A., Pecora, D., Gallagher, M. M., Rillo, M., Viola, G., Pisano, E., Abbey, S., Lamberti, F., Pani, A., Zucchelli, G., Sgarito, G., De Simone, A., Bertaglia, E., Solimene, F., and Stabile, G.
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medicine.medical_specialty ,medicine.medical_treatment ,Catheter ablation ,030204 cardiovascular system & hematology ,Pulmonary vein ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,Fluoroscopy ,030212 general & internal medicine ,Pulmonary vein reconnection ,medicine.diagnostic_test ,business.industry ,Incidence (epidemiology) ,Ablation index ,Atrial fibrillation ,Ablation ,medicine.disease ,eye diseases ,Catheter ,Treatment Outcome ,Pulmonary Veins ,Cardiology ,Population study ,Cardiology and Cardiovascular Medicine ,business - Abstract
Purpose: Ablation index (AI) is a radiofrequency lesion quality marker. The AI value that allows effective and safe pulmonary vein isolation (PVI) is still debated. We evaluated the incidence of acute and late PV reconnection (PVR) with different AI settings and its predictors. Methods: The Ablation Index Registry is a multicenter study that included patients with paroxysmal/persistent atrial fibrillation (AF) who underwent first-time ablation. Each operator performed the ablation using his preferred ablation catheter (ThermoCool® SmartTouch or Surround Flow) and AI setting (380 posterior-500 anterior and 330 posterior-450 anterior). We divided the study population into two groups according to the AI setting used: group 1 (330–450) and group 2 (380–500). Incidence of acute PVR was validated within 30 min after PVI, whereas the incidence of late PVR was evaluated at repeat procedure. Results: Overall, 490 patients were divided into groups 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of the first-pass PVI between the two study groups. Acute PVR was observed in 5.6% PVs. The rate of acute PVR was slightly higher in group 2 (64/943, 6.8%, PVs) than in group 1 (48/1045, 4.6% PVs, p = 0.04). Thirty patients (6%) underwent a repeat procedure and late PVR was observed in 57/116 (49%) PVs (number of reconnected PV per patient of 1.9 ± 1.6). A similar rate of late PVR was found in the two study groups. No predictors of acute and late PVR were found. Conclusion: Ablation with a lower range of AI is highly effective and is not associated with a higher rate of acute and late PVR. No predictors of PV reconnection were found.
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- 2022
19. Innovative Cardiac Resynchronization
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Zaki Akhtar, Ian Beeton, Lisa W M Leung, Zhong Chen, and Mark M Gallagher
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0301 basic medicine ,medicine.medical_specialty ,CRT, cardiac resynchronization therapy ,left ventricle ,CRT-P, cardiac resynchronization therapy–pacemaker ,medicine.medical_treatment ,Cardiac resynchronization therapy ,GCV, great cardiac vein ,cardiac resynchronization therapy ,030105 genetics & heredity ,Cardiac pacemaker ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Mini-Focus Issue: Electrophysiology ,Diseases of the circulatory (Cardiovascular) system ,cardiovascular diseases ,Lead (electronics) ,Imaging Vignette: Technical Corner ,business.industry ,CS, coronary sinus ,Dilated right atrium ,LV, left ventricle ,medicine.anatomical_structure ,Ventricle ,RC666-701 ,Cardiac resynchronization ,Cardiology ,cardiovascular system ,Cardiology and Cardiovascular Medicine ,business ,030217 neurology & neurosurgery ,Coronary sinus ostium ,cardiac pacemaker - Abstract
An acutely angulated coronary sinus ostium coupled with a dilated right atrium presents technical challenges for cardiac resynchronization therapy (CRT) implantation. Innovative use of a deployable left ventricle lead as an anchor to support guidewire navigation within the cardiac venous system permits optimal CRT deployment. (Level of Difficulty: Advanced.), Central Illustration
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- 2021
20. Review paper on <scp>WPW</scp> and athletes: Let sleeping dogs lie?
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Mark M Gallagher and Lisa W M Leung
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Population ,Reviews ,Catheter ablation ,Review ,Accessory pathway ,030204 cardiovascular system & hematology ,pre‐excitation ,Asymptomatic ,sudden cardiac death ,Sudden cardiac death ,WPW ,Electrocardiography ,03 medical and health sciences ,0302 clinical medicine ,Heart Conduction System ,Heart Rate ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,education ,Wolff‐Parkinson‐White syndrome ,catheter ablation of accessory pathways ,education.field_of_study ,biology ,Athletes ,business.industry ,General Medicine ,medicine.disease ,biology.organism_classification ,athletes ,Increased risk ,cardiac screening ,Catheter Ablation ,Cardiology ,Wolff-Parkinson-White Syndrome ,medicine.symptom ,Presentation (obstetrics) ,Cardiology and Cardiovascular Medicine ,business - Abstract
Accessory pathways are present in 1 in 300 young individuals. They are often asymptomatic and potentially lethal arrhythmias may be the first presentation. During long‐term follow‐up, up to 20% of asymptomatic individuals with pre‐excitation go on to develop an arrhythmia and the absence of traditional clinical and electrophysiological high‐risk markers does not guarantee the “safe” nature of an accessory pathway. The widespread availability of permanent cure for the condition at low risk by catheter ablation, creates an incentive to screen for accessory pathways with a 12‐lead ECG, particularly in individuals who are perceived to be at increased risk, such as athletes and high‐risk professions. We review the existing literature on the assessment and management of accessory pathways (Wolff‐Parkinson‐White [WPW] syndrome) and discuss its implications for the young athletic population.
- Published
- 2020
21. Contact force sensing in ablation of ventricular arrhythmias using a 56-hole open-irrigation catheter: a propensity-matched analysis
- Author
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Abhay Bajpai, Manav Sohal, Riyaz Kaba, Mark M Gallagher, Mark Norman, Magdi Saba, Elijah R. Behr, Anthony Li, Ahmed I Elbatran, and Zia Zuberi
- Subjects
medicine.medical_specialty ,Irrigated radiofrequency ,Complications ,Catheters ,Ventricular ectopy ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Ablation ,Ventricular tachycardia ,Article ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,Internal medicine ,Atrial Fibrillation ,medicine ,Fluoroscopy ,Humans ,030212 general & internal medicine ,Normal heart ,Ejection fraction ,medicine.diagnostic_test ,business.industry ,Equipment Design ,medicine.disease ,Catheter ,Treatment Outcome ,Propensity score matching ,Cardiology ,Catheter Ablation ,Cardiology and Cardiovascular Medicine ,business ,Contact force - Abstract
Purpose The effect of adding contact force (CF) sensing to 56-hole tip irrigation in ventricular arrhythmia (VA) ablation has not been previously studied. We aimed to compare outcomes with and without CF sensing in VA ablation using a 56-hole radiofrequency (RF) catheter. Methods A total of 164 patients who underwent first-time VA ablation using Thermocool SmartTouch Surround Flow (TC-STSF) catheter (Biosense-Webster, Diamond Bar, CA, USA) were propensity-matched in a 1:1 fashion to 164 patients who had first-time ablation using Thermocool Surround Flow (TC-SF) catheter. Patients were matched for age, gender, cardiac aetiology, ejection fraction and approach. Acute success, complications and long-term follow-up were compared. Results There was no difference between procedures utilising either TC-SF or TC-STSF in acute success (TC-SF: 134/164 (82%), TC-STSF: 141/164 (86%), p = 0.3), complications (TC-SF: 11/164 (6.7%), TC-STSF: 11/164 (6.7%), p = 1.0) or VA-free survival (TC-SF: mean arrhythmia-free survival time = 5.9 years, 95% CI = 5.4–6.4, TC-STSF: mean = 3.2 years, 95% CI = 3–3.5, log-rank p = 0.74). Fluoroscopy time was longer in normal hearts with TC-SF (19 min, IQR: 14–30) than TC-STSF (14 min, IQR: 8–25; p = 0.04). Conclusion Both TC-SF and TC-STSF catheters are safe and effective in treating VAs. The use of CF sensing catheters did not improve safety or acute and long-term outcomes, but reduced fluoroscopy time in normal heart VA.
- Published
- 2020
22. Left atrial appendage isolation during ablation in the interatrial septum: Rapid recognition by continuous monitoring of appendage electrograms
- Author
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Ahmed I Elbatran, Lisa W M Leung, and Mark M Gallagher
- Subjects
Male ,Tachycardia ,medicine.medical_specialty ,medicine.medical_treatment ,Catheter ablation ,030204 cardiovascular system & hematology ,Pulmonary vein ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Atrial Fibrillation ,Humans ,Medicine ,Atrial Appendage ,cardiovascular diseases ,030212 general & internal medicine ,Atrial tachycardia ,Aged ,Atrial Septum ,business.industry ,Atrial fibrillation ,General Medicine ,medicine.disease ,Ablation ,medicine.anatomical_structure ,Catheter Ablation ,cardiovascular system ,Cardiology ,Atrial Ablation ,medicine.symptom ,Electrophysiologic Techniques, Cardiac ,Cardiology and Cardiovascular Medicine ,business ,Interatrial septum - Abstract
Extensive atrial ablation in the setting of atrial fibrillation (AF) and atrial tachycardia (AT) can affect interatrial connections. A 76-year-old man with a history of tachycardia-induced cardiomyopathy and nine ablation procedures for AF/AT over 15 years presented with highly symptomatic recurrent AT. Previous ablation lesions included pulmonary vein isolation, left atrial posterior wall isolation, mitral isthmus line, cavotricuspid isthmus line, and the ablation of areas of fractionated electrograms. Electroanatomical mapping found the pulmonary veins and the left atrial posterior wall to be silent, as was the posterior interatrial septum and the mitral isthmus area. Activation mapping showed progression of electrograms in the left atrial appendage (LAA) from the septal aspect posteriorly, and in the coronary sinus from proximal to distal; implying the existence of a septal circuit, where extensive fractionation was noted. This was targeted, while monitoring conduction into the LAA using a multielectrode catheter. Ablation led to prompt termination of tachycardia and simultaneous LAA isolation. Immediate cessation of ablation led to recovery of conduction into LAA. Additional lesions in the interatrial septum were required to render the tachycardia noninducible, accompanied by temporary isolation of LAA. The ablation lesion sets employed while ablating AF and left AT can block many interatrial pathways, rendering conduction dependent on muscle bundles in the interatrial septum and, therefore, vulnerable to block by lesions in this area. LAA isolation has been associated with high incidence of LAA thrombus formation and stroke despite oral anticoagulation. Continuous observation of LAA electrograms during ablation can help to avoid this complication.
- Published
- 2019
23. First-line management of paroxysmal atrial fibrillation: is it time for a 'pill in the bin' approach? A discussion on the STOP AF First, EARLY AF, Cryo-FIRST, and EAST-AF NET 4 clinical trials
- Author
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Zaki Akhtar, Mark M Gallagher, Sreenivasa Rao Kondapally Seshasai, and Lisa W M Leung
- Subjects
medicine.medical_specialty ,business.industry ,Paroxysmal atrial fibrillation ,First line ,MEDLINE ,Clinical trial ,Pulmonary Veins ,Physiology (medical) ,Internal medicine ,Pill ,Atrial Fibrillation ,medicine ,Cardiology ,Catheter Ablation ,Humans ,Cardiology and Cardiovascular Medicine ,business - Published
- 2021
24. Protecting Against Collateral Damage to Non-cardiac Structures During Endocardial Ablation for Persistent Atrial Fibrillation
- Author
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Lisa WM Leung, Zaki Akhtar, Jamal Hayat, and Mark M Gallagher
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Injury to structures adjacent to the heart, particularly oesophageal injury, accounts for a large proportion of fatal and life-altering complications of ablation for persistent AF. Avoiding these complications dictates many aspects of the way ablation is performed. Because avoidance involves limiting energy delivery in areas of interest, fear of extracardiac injury can impede the ability of the operator to perform an effective procedure. New techniques are becoming available that may permit the operator to circumvent this dilemma and deliver effective ablation with less risk to adjacent structures. The authors review all methods available to avoid injury to extracardiac structures to put these developments in context.
- Published
- 2021
25. Preventing Fatal Injury to the Superior Vena Cava
- Author
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Christoph Starck, Mark M Gallagher, and Zaki Akhtar
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Superior Vena Cava Syndrome ,Vena Cava, Superior ,business.industry ,Thorax ,Fatal injury ,Surgery ,Superior vena cava ,Medicine ,Humans ,Cardiology and Cardiovascular Medicine ,business - Published
- 2021
26. PO-648-01 DIAGNOSTIC PERFORMANCE OF THE CONFIRM RX WITH SHARPSENSE TECHNOLOGY FOR AF EPISODES OF DIFFERENT DURATION: UK EXPERIENCE
- Author
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Andre Rodrigues Pontes Briosa e Gala, Michael TB Pope, Milena Leo, Julian O.M. Ormerod, Honey Thomas, Mark M. Gallagher, Ross J. Hunter, Duncan C. Field, David Wilson, Roy S. Gardner, John Paisey, and Timothy R. Betts
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2022
27. Economic Evaluation of Catheter Ablation Versus Medical Therapy for the Treatment of Atrial Fibrillation from the Perspective of the UK
- Author
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Lisa WM Leung, Zaki Akhtar, Christos Kontogiannis, Ryan J Imhoff, Hannah Taylor, and Mark M Gallagher
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Randomised evidence supports an early rhythm control strategy as treatment for AF, and catheter ablation outperforms medical therapy in terms of effectiveness when studied as first- and second-line treatment. Despite evidence consistently showing that catheter ablation treatment is superior to medical therapy in most AF patients, only a small proportion receive ablation, in some cases after a prolonged trial of ineffective medical therapy. Health economics research in electrophysiology remains limited but is recognised as being important in influencing positive change to ensure early access to ablation services for all eligible patients. Such information has informed the updated recommendations from the recently published National Institute for Health and Care Excellence clinical guideline on the diagnosis and management of AF, but increased awareness is needed to drive real-world adoption and to ensure patients are quickly referred to specialists. In this article, economic evaluations of catheter ablation versus medical therapy are reviewed.
- Published
- 2021
28. Subacute left main stem thrombus in COVID-19: a case report
- Author
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Lisa W M Leung, Zaki Akhtar, Sumeet Sharma, and Mark M Gallagher
- Subjects
2019-20 coronavirus outbreak ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Images in Cardiology ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,medicine.disease ,Left coronary artery ,medicine.artery ,Internal medicine ,medicine ,Cardiology ,Coronary Heart Disease ,AcademicSubjects/MED00200 ,Thrombus ,Cardiology and Cardiovascular Medicine ,business ,Main stem - Published
- 2021
29. Oesophageal thermal protection during AF ablation: effect on left atrial myocardial ablation lesion formation and patient outcomes
- Author
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B Evranos, A Bajpai, Zia Zuberi, Mark Norman, N Al Subaie, Mark M Gallagher, A Li, Lisa W M Leung, Manav Sohal, G Dhillon, A El Batran, Jamal Hayat, RA Kaba, Zaki Akhtar, and J Louis-Auguste
- Subjects
medicine.medical_specialty ,Thermal injury ,medicine.diagnostic_test ,Radiofrequency ablation ,business.industry ,Surrogate endpoint ,medicine.medical_treatment ,Cardiac arrhythmia ,Atrial fibrillation ,Ablation ,medicine.disease ,law.invention ,Left atrial ,law ,Physiology (medical) ,Internal medicine ,Cardiology ,medicine ,Fluoroscopy ,Cardiology and Cardiovascular Medicine ,business - Abstract
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Dr Leung has received research support from Attune Medical (Chicago, IL). Dr Gallagher has received research funding from Attune Medical (Chicago, IL). Background Randomized evidence has shown that controlled oesophageal cooling is effective at reducing oesophageal thermal injury during radiofrequency (RF) ablation for atrial fibrillation (AF) compared to standard care. The effect of oesophageal cooling on ablation lesion formation in left atrial myocardium and patient outcomes at 12-months had not been previously studied. Purpose To determine the effect of oesophageal cooling on the formation of RF lesions, the ability to achieve procedural endpoints and long-term patient outcomes compared to standard care ablations. Methods Ablation results and patient outcomes from a double-blind randomized controlled trial were analysed (IMPACT trial NCT03819946). AF ablation was guided by Ablation Index technology (30W at 350-400 AI posteriorly, 40W at 450 AI anteriorly). A blinded 1:1 randomization assigned patients to the use of an oesophageal temperature control device to keep oesophageal temperature at 4 degrees during ablation or standard practice using a single-sensor temperature probe. Ablation parameters and 12-month outcomes were analysed. Results We recruited 188 patients. Procedure and fluoroscopy times were similar. First pass pulmonary vein isolation and reconnection at the end of the waiting period were similar in both randomized groups (51/64 vs 51/68; p = 0.54 and 5/64 vs 7/68; p = 0.76, respectively). Posterior wall isolation was also similar: 24/33 vs 27/38; p = 0.88. Ablation effect on myocardial tissue, measured in impedance drop, was also similar: 8.6Ω (IQR: 6-11.8) vs 8.76Ω (IQR: 6-12.2; p = 0.25) and median catheter tip temperature was the same at 25.5 degrees. Arrhythmia recurrence was similar at 12 months (20.3% vs 26.8%, from 142 completed assessments; p = 0.66). Conclusions Oesophageal cooling has been shown to be effective in reducing ablation-related oesophageal thermal injury during RF ablation. Ablation data show that this protection does not make it any more difficult to achieve standard procedural endpoints or clinical success at 12-months. Abstract Figure. Pyramid frequency plots of AI values
- Published
- 2021
30. A registry review of 2532 catheter ablations for atrial fibrillation using active thermal protection
- Author
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Zaki Akhtar, Mark M Gallagher, A Li, B Evranos, RA Kaba, N Al Subaie, A Bajpai, Zia Zuberi, J Louis-Auguste, Mark Norman, Idris Harding, Lisa W M Leung, Manav Sohal, Hanney Gonna, and Jamal Hayat
- Subjects
medicine.medical_specialty ,Thermal injury ,business.industry ,Cardiac electrophysiology ,medicine.medical_treatment ,Atrial fibrillation ,Cardiac Ablation ,medicine.disease ,Ablation ,Catheter ,medicine.anatomical_structure ,Physiology (medical) ,Internal medicine ,Cardiology ,Medicine ,Esophagus ,Cardiology and Cardiovascular Medicine ,business ,Adverse effect - Abstract
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Dr Leung has received research support from Attune Medical (Chicago, IL). Dr Gallagher has received research funding from Attune Medical (Chicago, IL). Background Thermal injury to the oesophagus causes a spectrum of adverse effects after ablation for atrial fibrillation (AF); at the most severe end, atrio-oesophageal fistula carries a high mortality rate. Controlled active thermal protection in the oesophagus during ablation is the most promising method of oesophageal protection. Randomized evidence from the IMPACT trial (NCT03819946) showed an 83.4% reduction in endoscopically detected oesophageal lesions compared to standard care when an oesophageal temperature control device was used to control the local temperature. The IMPACT patients who were randomized to the use of the device had no adverse event related to its use. Real world registry data on applications of this device have not previously been available. Purpose To determine the safety of an oesophageal temperature control device by review of real-world registry data on its clinical use and any reported device-related adverse events. Methods We reviewed the following databases for any reported oesophageal temperature control device-related complications: The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA). An internal registry (post-marketing follow up) database maintained by the manufacturer of the device was used to quantify the number used for each indication. Reported events were reviewed and catalogued for description and identification of any events related to its use in the cardiac electrophysiology lab. The IMPACT study patients were reviewed for any device-related events. Results Of the 13, 284 oesophageal temperature control devices used, 2532 were recorded as having been used for the purpose of oesophageal protection during catheter ablation for AF. A total of 5 events associated with the device were identified, all from the MAUDE database. Three were from 2017, one from 2018, and one from 2019. All involved its use in critical care or trauma patients and were related to user error or contraindicated patient selection; none resulted in serious harm to the patient. No adverse events occurred related to its use in the cardiac electrophysiology lab. No case of clinically significant oesophageal injury was reported in a patient who had been protected by the oesophageal temperature control device. Conclusions Real world registry data has shown no adverse events reported to date in over 2500 uses of an oesophageal temperature control device in the cardiac electrophysiology lab, for the purpose of active thermal protection. This data supports the randomized trial evidence of its clinical effectiveness. Abstract Figure. Oesophageal active thermal protection
- Published
- 2021
31. Transvenous lead revision for cardiac perforation: a single centre experience
- Author
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Zia Zuberi, R Kaba, Mark M Gallagher, Abhay Bajpai, Manav Sohal, A Grimster, Ahmed I Elbatran, M Saba, L Wm Leung, Simon Pearse, Zaki Akhtar, Anthony Li, and M Norman
- Subjects
medicine.medical_specialty ,business.industry ,Pleural effusion ,Cancer ,Chest pain ,medicine.disease ,Pericardial effusion ,Transvenous lead ,Single centre ,Physiology (medical) ,Cardiac Perforation ,medicine ,Medical imaging ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
Funding Acknowledgements Type of funding sources: None. Background Cardiac perforation is an uncommon but life-threatening complication of cardiac implantable electronic device (CIED) implantation. Management strategy commonly relies on diagnostic Computed Tomography (CT) imaging and cardiac surgery. Emerging evidence has indicated a diversion from this approach. Transvenous culprit lead revision has been shown to be safe and efficacious in limited series. We sought to evaluate the outcomes of transvenous lead revision in patients with cardiac perforation. Method Data was collected retrospectively of patients admitted to a single tertiary centre with CIED-related cardiac perforation between December 2013 – October 2019. Transvenous lead revision was performed as standard with cardiac surgery on standby. Patient demographics, use of CT imaging, method of removal and 30-day outcomes were recorded. Results Of the 46 recorded CIED-related cardiac perforations, the majority occurred in female patients (63%) and hypertensives (61%), whilst a proportion had cancer (20%) and ischaemic heart disease (30%). The culprit in most cases was a standard pacing lead (92%) of an active fixation (98%) in the right ventricle (80%) positioned at the ventricular apex (65%). The median time to presentation from implant was 14 days [IQR 4-50 days] with chest pain (44%); abnormal pacing indices was highly prevalent (95%) whilst a pericardial effusion was noted in the majority of cases (57%). CT scanning was performed in 19 cases (41%) for various indications but deemed essential in only 4, all of which had non-diagnostic pacing indices and imaging. Chest X-ray (CXR) found clear perforation, lead displacement or pleural effusion in 74% of cases, whilst an echocardiogram found these in 64% of cases. The culprit lead was replaced in the majority of cases (87%) under local anaesthesia (76%) with surgical backup. The median hospital stay was 7 days [IQR 3-10 days] with zero procedural and 30-day mortality. Conclusion Transvenous lead revision for CIED-related cardiac perforation is safe and efficacious. CT modality for diagnostic purposes is useful in providing incremental value in a minority of cases; patients with non-diagnostic pacing parameters and non-CT imaging benefit most from this.
- Published
- 2021
32. Cost-effectiveness of catheter ablation versus medical therapy for the treatment of atrial fibrillation in the United Kingdom
- Author
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D Frame, Lisa W M Leung, Mark M Gallagher, Peter J. Mallow, H Taylor, L Goldstein, and RJ Imhoff
- Subjects
medicine.medical_specialty ,Cost effectiveness ,business.industry ,medicine.medical_treatment ,Catheter ablation ,Atrial fibrillation ,Cardiac Ablation ,Ablation ,medicine.disease ,Surgery ,Quality-adjusted life year ,Physiology (medical) ,Heart failure ,medicine ,Cardiology and Cardiovascular Medicine ,Adverse effect ,business - Abstract
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): This research study was funded by Biosense Webster, Inc. Dr Leung has received research support from Attune Medical (Chicago, IL) towards a research fellowship at St. George"s University of London. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Background Randomised data on patient-related outcomes comparing catheter ablation to medical therapy for the treatment of atrial fibrillation (AF) have shown the effectiveness of catheter ablation. Ablation versus medical therapy should also be analysed from a health economics perspective to achieve optimal healthcare resource allocation. Purpose To determine the cost effectiveness of catheter ablation compared to medical therapy for the treatment of atrial fibrillation, from the perspective of the UK National Health Service. Methods A patient-level Markov health-state transition model was used to conduct a cost utility analysis comparing catheter ablation and medical therapy for the treatment of AF. A systematic review and meta-analysis of catheter ablation treatment versus medical therapy (rhythm and/or rate control drugs) was conducted to enable comparison of AF recurrence between treatment groups utilising the model. Additional model parameters were established based upon a best-evidence review of the literature. The model simulated care delivered from a secondary care perspective. Total patients simulated in this model over a lifetime were 250,000, with patients entering the model at age 64. Only previously treated AF patients were included, including those with concomitant heart failure. A separate scenario analysis was conducted to determine the cost effectiveness specifically in the cohort of patients with AF and heart failure. Main outcomes measures Incremental cost-effectiveness ratio (ICER) and average total expected costs and quality-of-life years (QALYs) incurred over the lifetime of a patient. AF recurrence, complications and cardiovascular adverse events were compared over the total duration inside the model. Results In the base case analysis, catheter ablation resulted in a favourable ICER of £8,614 per additional QALY gained when compared to medical therapy, well below the national Willingness-to-Pay threshold of £20,000. Catheter ablation was associated with an expected increase of 1.01 QALYs, while adding an additional cost £8,742 over a patient’s lifetime. The cost-effectiveness of catheter ablation was improved in the heart failure sub-group analysis, with an ICER of £6,438. A significantly greater proportion of patients in the medical therapy group failed rhythm control at any stage compared to catheter ablation (72% vs 24%) and at a faster rate (median time to treatment failure: 3.8 vs 10 years). Conclusion Catheter ablation appears to be a highly cost-effective treatment for atrial fibrillation, compared to medical therapy, from the perspective of the UK National Health Service. With low rates of adverse events and superiority in achieving rhythm control, AF ablation services should be prioritised with appropriate allocation of healthcare resources.
- Published
- 2021
33. PROMET: The effect of operator profession on non-laser transvenous lead extraction
- Author
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L Wm Leung, Christoph Starck, Zaki Akhtar, Mark M Gallagher, Ahmed I Elbatran, and Manav Sohal
- Subjects
law ,business.industry ,Physiology (medical) ,Operator (physics) ,Extraction (chemistry) ,Medicine ,Cardiology and Cardiovascular Medicine ,Laser ,business ,Device implant ,Simulation ,Transvenous lead ,law.invention - Abstract
Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.
- Published
- 2021
34. PROMET: the effect of age on patient outcomes in non-laser transvenous lead extraction
- Author
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Christoph Starck, Ahmed I Elbatran, Zaki Akhtar, L Wm Leung, Mark M Gallagher, and Manav Sohal
- Subjects
medicine.medical_specialty ,law ,business.industry ,Physiology (medical) ,Extraction (chemistry) ,medicine ,Radiology ,Cardiology and Cardiovascular Medicine ,Laser ,business ,law.invention ,Transvenous lead - Abstract
Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background Cardiac implantable electronic devices (CIEDs) improve morbidity and mortality. This has fuelled an upsurge in implantation of these devices across all patient cohorts, simultaneously increasing the need for transvenous lead extractions (TLE). As the global population expands and life-expectancy extends, TLE will play a significant role in CIED management. Advancing patient age is a recognised risk factor for poor outcomes however the association between patient age and TLE outcomes remains unclear. We sought to evaluate the relationship between patient age and non-laser TLE outcomes. Method Data of 2205 patients (3849 leads) was collected retrospectively from six high-volume TLE institutes across Europe (PROMET) between January 2005-December 2018. Propensity 1:1 score matching was performed to limit the effects of confounding variables, pairing 353 patients in the >80 years of age category with 353 patients in Results In the 80 years-of-age cohorts, there was a similar proportion of male patients (65.3% vs 67.9%, p = 0.47) treated under general anaesthesia (96.5% vs 93.4%, p = 0.078) for a pre-dominant infectious indication (56.7% vs 60.3%, p = 0.52) but with a higher requirement of the EvolutionTM sheath in the octogenarians (39.4% vs 48.4%, p = 0.015). A similar clinical success per lead was achieved between the two age groups (96.6% vs 98%, 80 years, p = 0.245) as was complete lead extraction (95.5% vs 96.6%, 80 years, p = 0.44) with a comparable minor complication rate (2.3% vs 3.1%, 80 years, p = 0.29) and major complications (1.1% vs 1.4%, 80 years, p = 0.74). Thirty-day mortality was higher in the octogenarian cohort than the Conclusion Transvenous lead extraction is similar in efficacy and safety across all age groups. Thirty-day mortality is higher in the advanced age group, signifying the importance of post-procedural management in this cohort.
- Published
- 2021
35. PO-711-03 A RANDOMISED COMPARISON OF METHODOLOGY IN CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION: RESULTS AT UP TO A DECADE
- Author
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Mark M. Gallagher, Manav Sohal, Zaki Akhtar, Yi Gang, Hanney Gonna, Abhay Bajpai, Zia Zuberi, Mark Norman, and Lisa WM. Leung
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2022
36. CA-528-03 A REGISTRY REVIEW UPDATE OF 7120 CATHETER ABLATIONS FOR ATRIAL FIBRILLATION USING A DEDICATED ESOPHAGEAL TEMPERATURE CONTROL DEVICE FOR PROTECTION
- Author
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Lisa WM. Leung, Zaki Akhtar, Abhay Bajpai, Zia Zuberi, Anthony Li, Mark Norman, Riyaz A. Kaba, Manav Sohal, and Mark M. Gallagher
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2022
37. PO-648-02 INCIDENCE OF FALSE-POSITIVE AF DETECTION WITH THE NEW CONFIRM RX™ WITH SHARP-SENSE TECHNOLOGY IN ‘REAL-WORLD’ PATIENTS
- Author
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Andre Rodrigues Pontes Briosa e Gala, null Michael TB Pope, Milena Leo, Julian O.M. Ormerod, Honey Thomas, Mark M. Gallagher, Roy S. Gardner, Duncan C. Field, David Wilson, Ross J. Hunter, John Paisey, and Timothy R. Betts
- Subjects
Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2022
38. Leadless cardiac resynchronization therapy: a distant Utopia
- Author
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Zaki Akhtar, Lisa W M Leung, Manav Sohal, and Mark M Gallagher
- Subjects
medicine.medical_specialty ,Pacemaker, Artificial ,Utopia (typeface) ,business.industry ,medicine.medical_treatment ,Cardiac Resynchronization Therapy Devices ,MEDLINE ,Cardiac resynchronization therapy ,Cardiac Resynchronization Therapy ,Chronic disease ,Utopias ,Physiology (medical) ,Chronic Disease ,medicine ,Humans ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business - Published
- 2021
39. Prolonged QT predicts prognosis in COVID-19
- Author
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Lisa W M Leung, Aodhan Breathnach, Victoria Ewasiuk, Ahmed I Elbatran, Mark M Gallagher, Zhong Chen, Zaki Akhtar, Brendan Madden, Louise Gregory, Sumeet Sharma, Yee Guan Yap, and David Fluck
- Subjects
Male ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Long QT syndrome ,Prolonged QT ,030204 cardiovascular system & hematology ,Azithromycin ,ECG abnormality ,QT interval ,Article ,03 medical and health sciences ,Electrocardiography ,0302 clinical medicine ,Internal medicine ,Medicine ,Humans ,030212 general & internal medicine ,T-wave inversion ,Mortality ,medicine.diagnostic_test ,business.industry ,SARS-CoV-2 ,COVID-19 ,Hydroxychloroquine ,General Medicine ,Emergency department ,medicine.disease ,Prognosis ,Long QT Syndrome ,Female ,Cardiology and Cardiovascular Medicine ,business ,COVID 19 ,medicine.drug - Abstract
Coronavirus disease-2019 (COVID-19) causes severe illness and multi-organ dysfunction. An abnormal electrocardiogram is associated with poor outcome, and QT prolongation during the illness has been linked to pharmacological effects. This study sought to investigate the effects of the COVID-19 illness on the corrected QT interval (QTc).For 293 consecutive patients admitted to our hospital via the emergency department for COVID-19 between 01/03/20 -18/05/20, demographic data, laboratory findings, admission electrocardiograph and clinical observations were compared in those who survived and those who died within 6 weeks. Hospital records were reviewed for prior electrocardiograms for comparison with those recorded on presentation with COVID-19.Patients who died were older than survivors (82 vs 69.8 years, p 0.001), more likely to have cancer (22.3% vs 13.1%, p = 0.034), dementia (25.6% vs 10.7%, p = 0.034) and ischemic heart disease (27.8% vs 10.7%, p 0.001). Deceased patients exhibited higher levels of C-reactive protein (244.6 mg/L vs 146.5 mg/L, p 0.01), troponin (1982.4 ng/L vs 413.4 ng/L, p = 0.017), with a significantly longer QTc interval (461.1 ms vs 449.3 ms, p = 0.007). Pre-COVID electrocardiograms were located for 172 patients; the QTc recorded on presentation with COVID-19 was longer than the prior measurement in both groups, but was more prolonged in the deceased group (448.4 ms vs 472.9 ms, pre-COVID vs COVID, p 0.01). Multivariate Cox-regression analysis revealed age, C-reactive protein and prolonged QTc of 455 ms (males) and 465 ms (females) (p = 0.028, HR 1.49 [1.04-2.13]), as predictors of mortality. QTc prolongation beyond these dichotomy limits was associated with increased mortality risk (p = 0.0027, HR 1.78 [1.2-2.6]).QTc prolongation occurs in COVID-19 illness and is associated with poor outcome.
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- 2021
40. Finding the heart of the problem: A letter to the editor on 'Detection of oesophageal course during left atrial ablation' by Santoro et al
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Mark M Gallagher, Zaki Akhtar, and Lisa Wm Leung
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medicine.medical_specialty ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Letter to the editor ,business.industry ,medicine.medical_treatment ,General surgery ,MEDLINE ,Ablation ,Left atrial ,lcsh:RC666-701 ,Physiology (medical) ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,Letter to the Editor - Published
- 2021
41. Percutaneous management of lead-related cardiac perforation with limited use of computed tomography and cardiac surgery
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Zaki Akhtar, Mark Norman, Ahmed I Elbatran, Mark M Gallagher, Zia Zuberi, Abhay Bajpai, Alexander Grimster, Simon Pearse, Magdi Saba, Anthony Li, Lisa W M Leung, Manav Sohal, and Riyaz Kaba
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Male ,Reoperation ,medicine.medical_specialty ,Percutaneous ,Pleural effusion ,medicine.medical_treatment ,Perforation (oil well) ,030204 cardiovascular system & hematology ,Pericardial effusion ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Risk Factors ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Device Removal ,Aged ,business.industry ,General Medicine ,Implantable cardioverter-defibrillator ,medicine.disease ,Cardiac surgery ,Defibrillators, Implantable ,Heart Injuries ,Echocardiography ,Female ,Radiology ,Tamponade ,Cardiology and Cardiovascular Medicine ,business ,Tomography, X-Ray Computed - Abstract
Background Cardiac implantable electronic device (CIED)-related perforation is uncommon but potentially lethal. Management typically includes the use of computed tomography (CT) scanning and often involves cardiac surgery. Methods Patients presenting to a single referral centre with CIED-related cardiac perforation between 2013 and 2019 were identified. Demographics, diagnostic modalities, the method of lead revision, and 30-day complications were examined. Results A total of 46 cases were identified; median time from implantation to diagnosis was 14 days (interquartile range = 4-50). Most were females (29/46, 63%), 9/46 (20%) had cancer, 18 patients (39%) used oral anticoagulants, and no patients had prior cardiac surgery. Active fixation was involved in 98% of cases; 9% involved an implantable cardioverter defibrillator lead. Thirty-seven leads perforated the right ventricle (apex: 24) and 9 punctured the right atrium (lateral wall: 5). Abnormal electrical parameters were noted in 95% of interrogated cases. Perforation was visualized in 41% and 6% of cases with chest X-ray (CXR) and transthoracic echocardiography, respectively. CXR revealed a perforation, gross lead displacement, or left-sided pleural effusion in 74% of cases. Pericardial effusion occurred in 26 patients (57%) of whom 11 (24%) developed tamponade, successfully drained percutaneously. Pre-extraction CT scan was performed in 19 patients but was essential in four cases. Transvenous lead revision (TLR) was successfully performed in all cases with original leads repositioned in six patients, without recourse to surgery. Thirty-day mortality and complications were low (0% and 26%, respectively). Conclusion CT scanning provides incremental diagnostic value in a minority of CIED-related perforations. TLR is a safe and effective strategy.
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- 2021
42. Exclusively cephalic venous access for cardiac resynchronisation: A prospective multi-centre evaluation
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Mark M Gallagher, Ian Beeton, Idris Harding, Nilanka Mannakkar, Anthony Li, Andrew T Cox, Hanney Gonna, Zhong Chen, Zia Zuberi, Lisa Wm Leung, Abhay Bajpai, Joseph Lalor, Manav Sohal, and Giulia Domenichini
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Male ,medicine.medical_specialty ,030204 cardiovascular system & hematology ,Cardiac Resynchronization Therapy ,03 medical and health sciences ,0302 clinical medicine ,Catheterization, Peripheral ,medicine ,Seldinger technique ,Humans ,030212 general & internal medicine ,Cardiac Resynchronization Therapy Devices ,Prospective Studies ,Multi centre ,Axillary Vein ,Lead (electronics) ,Aged ,Cephalic vein ,Access route ,business.industry ,General Medicine ,medicine.disease ,Venous access ,Surgery ,Pneumothorax ,Female ,Clinical Competence ,Cardiology and Cardiovascular Medicine ,business ,Subclavian vein - Abstract
BACKGROUND: Small series has shown that cardiac resynchronisation therapy (CRT) can be achieved in a majority of patients using exclusively cephalic venous access. We sought to determine whether this method is suitable for widespread use. METHODS: A group of 19 operators including 11 trainees in three pacing centres attempted to use cephalic access alone for all CRT device implants over a period of 8 years. The access route for each lead, the procedure outcome, duration, and complications were collected prospectively. Data were also collected for 105 consecutive CRT device implants performed by experienced operators not using the exclusively cephalic method. RESULTS: A new implantation of a CRT device using exclusively cephalic venous access was attempted in 1091 patients (73.6% male, aged 73 ± 12 years). Implantation was achieved using cephalic venous access alone in 801 cases (73.4%) and using a combination of cephalic and other access in a further 180 (16.5%). Cephalic access was used for 2468 of 3132 leads implanted (78.8%). Compared to a non-cephalic reference group, complications occurred less frequently (69/1091 vs 12/105; P = .0468), and there were no pneumothoraces with cephalic implants. Procedure and fluoroscopy duration were shorter (procedure duration 118 ± 45 vs 144 ± 39 minutes, P
- Published
- 2020
43. Mechanical deviation of the esophagus: Not an easy concept to swallow
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Zaki Akhtar, Mark M Gallagher, Jamal Hayat, and Lisa W M Leung
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medicine.medical_specialty ,business.industry ,Atrial fibrillation ,medicine.disease ,Surgery ,Atrioesophageal fistula ,medicine.anatomical_structure ,Esophagus ,Physiology (medical) ,medicine ,Catheter Ablation ,Humans ,Cardiology and Cardiovascular Medicine ,business ,Af ablation - Published
- 2020
44. 16-month outcomes following hybrid ablation for long-standing persistent atrial fibrillation in patients with dilated atria
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Manav Sohal, A Elbadri, Mark M Gallagher, A Bajpay, Venkatachalam Chandrasekaran, Rajan Sharma, Philemon Gukop, A Momin, RA Kaba, M Saba, A Ashry, and A Li
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Internal medicine ,Persistent atrial fibrillation ,medicine ,Cardiology ,In patient ,Cardiology and Cardiovascular Medicine ,Ablation ,business - Abstract
Introduction Although catheter ablation therapy is a well-established treatment for cardiac dysrhythmias, the success rates for longstanding, persistent AF with dilated atria remain unsatisfactory. The minimally invasive hybrid technology is a novel form of therapy. Methods A prospective, single-center UK study to evaluate the hybrid ablation technique for patients with longstanding (>1 year) persistent AF and dilated atria. Stage 1 was a minimally invasive epicardial approach for ablation of the posterior wall of left atrium (LA) and pulmonary veins (PVs). Stage 2 was a transcatheter approach via the femoral veins to isolate the endocardial aspect of the PVs +/− posterior wall. Occasionally, the sequence of the stages was reversed. Results Forty-one patients were enrolled for the study with a mean follow-up for 16±9 months. Mean age was 65±9 years and the mean BMI was 32±7. Males constituted 75% of the study cohort. Mean LA size was 48±7 mm and mean left ventricular ejection fraction (LVEF) was 51.9%, although 51.6% of patients had impaired LVSF (LVEF below 55%). 87.8% CI (0.7–0.9) of patients remained in sinus rhythm (SR) without repeat ablation, whereas only 12.2% CI (0.04–0.02) had redeveloped persistent AF. Although numerically different, there was no statistically significant difference in maintaining SR between patients with severely dilated LA (>50 mm) and those without (70% vs. 90%, respectively; z=−1.39, p=0.165). Major perioperative complications during stage 1 ablation were low, with IVC injury in 1 patient and a mild stroke in 1 patient. Median LOS was 1 day (1–4 days) and there was no 30-day mortality after stage 1. Conclusions The hybrid ablation therapy has a conversion rate from longstanding persistent AF to SR of 87.8% at a mean follow-up of 16±9 months, without repeat ablation. LOS was short, with very few complications and no peri-operative mortality. The hybrid approach appears to be very encouraging for a condition with otherwise low success rates by conventional endocardial techniques alone. Funding Acknowledgement Type of funding source: None
- Published
- 2020
45. Patient outcomes after AF ablation using Ablation Index technology with oesophageal protection: insight from the IMPACT study
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Zia Zuberi, J Louis-Auguste, Hanney Gonna, N Al-Subaie, Mark Norman, RA Kaba, A Bajpai, Jamal Hayat, A Li, B Evranos, Mark M Gallagher, Idris Harding, Zaki Akhtar, Lisa W M Leung, and Manav Sohal
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medicine.medical_specialty ,Index (economics) ,business.industry ,medicine.medical_treatment ,medicine ,Impact study ,Radiology ,Cardiology and Cardiovascular Medicine ,Ablation ,Af ablation ,business - Abstract
Background Atrio-oesophageal fistula formation accounts for the majority of AF ablation-related morbidity and mortality. Thermal injury to the oesophagus can be significantly reduced by application of oesophageal cooling for protection during AF ablation. The effect of this method of oesophageal protection in patients receiving radiofrequency (RF) ablation guided by Ablation Index technology is currently unknown. Objective To investigate the ability of a temperature control device to protect the oesophagus from ablation-related thermal injury in patients receiving AF ablation guided by Ablation Index technology. Methods The IMPACT study is a single-centre, prospective, double-blind randomized controlled trial, which investigated the ability of a controlled method of oesophageal cooling to protect the oesophagus from ablation-related thermal injury. The EnsoETM device was used to deliver oesophageal cooling. This method was compared in a 1:1 randomization to a control group of standard practice utilizing a single-sensor temperature probe. In the study group, the device was used to keep the luminal temperature at 4°C during RF ablation. All participants received AF ablation using Ablation Index technology at posterior and anterior settings (30W at 350–400 and 40W at 450–500, respectively). Endoscopic examination was performed within 7 days post-ablation and oesophageal injury was graded. The patient and the endoscopist were blinded to the randomization. Structured clinical follow up occurred after 3 months post-ablation; both patient and follow up clinician were blinded. Results We recruited 188 patients, of whom 120 underwent endoscopic evaluation. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 versus 2/60; P=0.008). There was no difference between groups in RF time, lesion duration, force, power and combined ablation index (P value range= 0.2–0.9). Procedure and fluoroscopy duration were similar (P=0.97, P=0.91 respectively). The majority of those who passed through the 1st follow up evaluation (n=136) did not have gastrointestinal or chest pain symptoms post ablation and there was no difference between the randomized groups. Only 4.4% overall had severe symptoms and they were poorly correlated against those who sustained mucosal lesions. AF recurrence was similar in both groups (8% vs 8.8%). There were 2 cases of vascular trauma needing intervention in the control group and 1 case of conservatively managed pericardial effusion in the protected group only. Clinical and endoscopy findings did not report any EnsoETM device-related trauma. Conclusion Thermal protection of the oesophagus significantly reduces ablation-related thermal injury compared to standard care when ablation is performed using radiofrequency with Ablation Index technology. This method of oesophageal protection is safe and does not compromise the efficacy of the ablation procedure. Endoscopy findings and patient symptoms. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): 1. Public hospital: St. George's NHS Foundation Trust; 2. Private company: Attune Medical (Chicago, IL)
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- 2020
46. 'Close' cardiac monitoring: life-threatening complication of a loop recorder implant
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Ian Beeton, Zaki Akhtar, Zhong Chen, Mark M Gallagher, and Lisa W M Leung
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medicine.medical_specialty ,AAA Domain ,business.industry ,medicine.medical_treatment ,Prostheses and Implants ,Syncope ,Cardiovascular monitoring ,Physiology (medical) ,medicine ,Electrocardiography, Ambulatory ,Humans ,Implant ,Cardiac monitoring ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business ,Complication ,Loop recorder - Published
- 2020
47. Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques
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Alessandra Marzi, Jürgen Eulert-Grehn, Jan Steffel, Manav Sohal, Pia Lanmüller, Christoph Starck, Elkin Gonzalez, Giulia Domenichini, Omar Al-Razzo, Mark M Gallagher, Alexander Breitenstein, Patrizio Mazzone, Francesco Melillo, Peter-Paul Delnoy, University of Zurich, and Starck, Christoph T
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medicine.medical_specialty ,610 Medicine & health ,2705 Cardiology and Cardiovascular Medicine ,2737 Physiology (medical) ,Interquartile range ,Clinical Research ,Physiology (medical) ,Medicine ,Major complication ,Laser lead extraction ,Lead (electronics) ,Technical success ,business.industry ,Mortality rate ,Retrospective cohort study ,Rotational lead extraction ,Surgery ,Leads and Lead Extraction ,Evolution extraction sheath ,10209 Clinic for Cardiology ,Cardiology and Cardiovascular Medicine ,Complication ,business ,Laser methods ,Lead extraction - Abstract
Aims Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques. Methods and results Data were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41–112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66–145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%. Conclusion Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.
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- 2020
48. Electrophysiology in the time of coronavirus: coping with the great wave
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Jiafeng Lin, Jin Li, Yuechun Li, Mark M. Gallagher, Giuseppe D'Angelo, Zaki Akhtar, Paolo Della Bella, Jun Ma, Patrizio Mazzone, Weiqian Lin, Jia Li, and Lisa W M Leung
- Subjects
2019-20 coronavirus outbreak ,Coping (psychology) ,medicine.medical_specialty ,China ,Coronavirus disease 2019 (COVID-19) ,Public health interventions ,Disease ,Coping behavior ,030204 cardiovascular system & hematology ,Ablation ,Workflow ,03 medical and health sciences ,0302 clinical medicine ,COVID-19 Testing ,Informed consent ,Clinical Research ,Physiology (medical) ,Pandemic ,London ,Restricted activity ,Medicine ,Humans ,AcademicSubjects/MED00200 ,030212 general & internal medicine ,Pandemics ,Research ethics ,business.industry ,SARS-CoV-2 ,Public health ,COVID-19 ,medicine.disease ,Electrophysiology ,Italy ,Family medicine ,Catheter ablation ,Local disease ,Medical emergency ,Cardiac Electrophysiology ,Cardiology Service, Hospital ,business ,Cardiology and Cardiovascular Medicine ,Arrhythmia - Abstract
AimsTo chart the effect of the COVID-19 pandemic on the activity of interventional electrophysiology services in affected regions.MethodsWe reviewed the electrophysiology laboratory records in 3 affected cities: Wenzhou in China, Milan in Italy and London, United Kingdom. We interviewed electrophysiologists in each centre to gather information on the impact of the pandemic on working patterns and on the health of staff members.ResultsThere was a striking decline in interventional electrophysiology activity in each of the centres. The decline occurred within a week of the recognition of widespread community transmission of the virus in each region and shows a striking correlation with the national figures for new diagnoses of COVID-19 in each case. During the period of restriction, work-flow dropped to th allowing the electrophysiology service to resume with a strict testing regime for all patients.ConclusionInterventional electrophysiology is vulnerable to closure in times of great social difficulty including the COVID-19 pandemic. Intense public health intervention can permit suppression of local disease transmission allowing resumption of some normal activity.CONDENSED ABSTRACTCOVID-19 has affected every aspect of life worldwide. In the electrophysiology labs of Wenzhou, Milan and London, activity was suspended as the disease took hold. Only Wenzhou has resumed normal services, facilitated by a monumental nationwide program of public health interventions and supported by stringent testing protocols.WHAT’S NEWWe describe the impact of the COVID-19 pandemic on interventional electrophysiology units in 3 cities: Wenzhou, Milan and London.In all cases, the routine work of the electrophysiology was virtually suspended within a week of the recognition of widespread virus transmission in the area.During the period of restricted activity imposed by the pandemic, centres have dealt with a small number of emergency ablations only, a balanced mix of atrial, ventricular and junctional arrhythmias.In 2 of the 3 centres, electrophysiologists were redeployed to perform other medical duties including in COVID-19 wards.COVID-19 infection occurred in medical and nursaing staff in 2 of the 3 centres.Only in the cases of Wenzhou, China, has a resumption of normal activity been possible; this follows intensive public health intervention and is protected by stringent testing.FUNDINGNoneETHICAL APPROVALNone required from the Research Ethics Committee (REC) London according to the type of study. Institutional ethical approval obtained at the centres of: St. George’s Hospital NHS Foundation Trust, London, UK; Local Health Authority Ethical Approval was obtained in: The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University in Wenzhou, PR China and San Raffaele in Milan, Italy.CONSENTInformed consent was obtained from all participants/interviewees who took part in this study.
- Published
- 2020
49. Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry
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Mariano Rillo, Nicolas Badenco, Mark M Gallagher, Marco Scaglione, Ermenegildo De Ruvo, Giuseppe Sgarito, Maurizio Del Greco, Daniela Dugo, Frederic Sebag, Antonio De Simone, Francesco Solimene, A. Pani, A. Castro, Maurizio Landolina, A. Lepillier, Giuseppe Stabile, Filippo Lamberti, Teresa Strisciuglio, Valerio De Santis, Massimo Grimaldi, Luca Rossi, Giulio Zucchelli, Salim Abbey, Emanuele Bertaglia, Ennio Pisano, Graziana Viola, Domenico Pecora, Matteo Anselmino, Stabile, G., Lepillier, A., De Ruvo, E., Scaglione, M., Anselmino, M., Sebag, F., Pecora, D., Gallagher, M., Rillo, M., Viola, G., Rossi, L., De Santis, V., Landolina, M., Castro, A., Grimaldi, M., Badenco, N., Del Greco, M., De Simone, A., Pisano, E., Abbey, S., Lamberti, F., Pani, A., Zucchelli, G., Sgarito, G., Dugo, D., Bertaglia, E., Strisciuglio, T., and Solimene, F.
- Subjects
Registrie ,medicine.medical_specialty ,medicine.medical_treatment ,Anterior wall ,Reproducibility of Result ,Catheter ablation ,030204 cardiovascular system & hematology ,Pulmonary vein ,Lesion ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Physiology (medical) ,Atrial Fibrillation ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Registries ,reproducibility ,Reproducibility ,ablation index ,atrial fibrillation ,catheter ablation ,business.industry ,Reproducibility of Results ,Atrial fibrillation ,Ablation ,medicine.disease ,Surgery ,Prospective Studie ,Catheter ,Treatment Outcome ,Pulmonary Veins ,Catheter Ablation ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Human - Abstract
Background Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. Methods A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). Results At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. Conclusions An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.
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- 2020
50. Remanufactured circular mapping catheters: safety, effectiveness and cost
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Manav Sohal, Zia Zuberi, Alexander Grimster, Anthony Li, Mark M Gallagher, Lisa Wm Leung, Abhay Bajpai, Banu Evranos, and Mark Norman
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Adult ,Male ,Infection risk ,Sterilisation ,Cost effectiveness ,Cardiac electrophysiology catheters ,030204 cardiovascular system & hematology ,Cardiac Catheters ,Article ,03 medical and health sciences ,0302 clinical medicine ,Physiology (medical) ,Atrial Fibrillation ,Equipment Reuse ,Humans ,Medicine ,New device ,Operations management ,Prospective Studies ,030212 general & internal medicine ,Remanufacturing ,Safety effectiveness ,Aged ,Aged, 80 and over ,Equipment Safety ,business.industry ,Equipment Design ,Middle Aged ,United Kingdom ,Cost savings ,Catheter ,Mapping system ,Catheter Ablation ,Female ,Cost-effectiveness ,Safety ,Cardiology and Cardiovascular Medicine ,Af ablation ,business ,Circular mapping catheters - Abstract
BACKGROUND: The use of remanufactured single-use devices (SUDs), including cardiac electrophysiology catheters, has become established in the USA and other health care systems but without much published scientific evaluation on the relative safety or efficacy of these devices. In the United Kingdom (UK), the use of remanufactured SUDs has not been routine. We performed a structured evaluation of the safety and efficacy of a remanufactured circular mapping catheter (Stryker® remanufactured Lasso NAV 2515) during its introduction in our centre. METHODS: We prospectively evaluated the performance of a remanufactured circular mapping catheter in 100 consecutive patients undergoing an AF ablation. Operator feedback was obtained, assessing the device appearance, ease of use and function. As an indirect measurement of efficacy, acute procedure metrics were compared to those in 100 propensity-matched cases performed by the same operators using a new device. Cost savings were calculated. RESULTS: No complication occurred in association with the remanufactured device. There was one reported failure of device malfunction-the flexion-extension mechanism of a remanufactured catheter and none in the matched-control group. There was satisfactory communication with the electro-anatomic mapping system. Ease of use of the remanufactured catheter was reported to be similar to a newly manufactured device. Procedural duration was similar with remanufactured devices and matched controls. With 100 cases using the remanufactured device, cost savings amounted to £30,444. CONCLUSIONS: The use of remanufactured circular mapping catheters is safe, efficient and reliable. Widespread use of remanufactured SUDs offers the possibility of significant economic benefit.
- Published
- 2019
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