Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades.

AIMS: Cardiac resynchronization therapy (CRT) upgrades may be less likely to improve following intervention. Leadless left ventricular (LV) endocardial pacing has been used for patients with previously failed CRT or high-risk upgrades. We compared procedural and long-term outcomes in patients undergoing coronary sinus (CS) CRT upgrades with high-risk and previously failed CRT upgrades undergoing LV endocardial upgrades. METHOD AND RESULTS: Prospective consecutive CS upgrades between 2015 and 2019 were compared with those undergoing WiSE-CRT implantation. Cardiac resynchronization therapy response at 6 months was defined as improvement in clinical composite score (CCS) and a reduction in LV end-systolic volume (LVESV) ≥15%. A total of 225 patients were analysed; 121 CS and 104 endocardial upgrades. Patients receiving WiSE-CRT tended to have more comorbidities and were more likely to have previous cardiac surgery (30.9% vs. 16.5%; P = 0.012), hypertension (59.2% vs. 34.7%; P < 0.001), chronic obstructive airways disease (19.4% vs. 9.9%; P = 0.046), and chronic kidney disease (46.4% vs. 21.5%; P < 0.01) but similar LV ejection fraction (30.0 ± 8.3% vs. 29.5 ± 8.6%; P = 0.678). WiSE-CRT upgrades were successful in 97.1% with procedure-related mortality in 1.9%. Coronary sinus upgrades were successful in 97.5% of cases with a 2.5% rate of CS dissection and 5.6% lead malfunction/displacement. At 6 months, 91 WiSE-CRT upgrades and 107 CS upgrades had similar improvements in CCS (76.3% vs. 68.5%; P = 0.210) and reduction in LVESV ≥15% (54.2% vs. 56.3%; P = 0.835). CONCLUSION: Despite prior failed upgrades and high-risk patients with more comorbidities, WiSE-CRT upgrades had high rates of procedural success and similar improvements in CCS and LV remodelling with CS upgrades.

UK multicenter retrospective comparison of novel active versus conventional passive fixation coronary sinus leads.

BACKGROUND: A novel active fixation coronary sinus (CS) lead, Attain Stability (AS), has been released aiming to improve targeted lead positioning. Rather than being wedged into the distal vessel, it relies on a side helix for fixation. We aimed to compare implant procedure parameters and electromechanical stability of the AS lead with passive CS leads. METHODS: A retrospective study involving six major UK cardiac centers. Patients who received active fixation leads were compared with passive fixation lead recipients in a 1:2 ratio. The primary outcome was total lead displacements (combined macrodisplacement/microdisplacement, defined as displacements requiring repositioning procedures, an increase in threshold ≥0.5 V or pulse width ≥0.5 ms, or a change in pacing polarity). RESULTS: A total of 761 patients were included (253 AS leads and 508 passive fixation leads), of which 736 had follow-up data. The primary endpoint rate was 31% (75/241) in the active and 43% (214/495) in the passive group (p = .002). Six patients (2.5%) in the active group and 14 patients (2.8%) in the passive group required CS lead repositioning procedures (p = 0.981). On multivariable analysis, active leads were associated with a reduction in lead displacements, odds ratio 0.66 (95% confidence interval: 0.46-0.95), p = .024. There were differences in favor of passive leads in procedure duration, 120 (96-149) versus 127 (105-155) min (p = .008), and fluoroscopy time, 17 (11-26) versus 18.5 (13-27) min (p = .0022). The median follow-up duration was similar (active vs. passive): 31 (17-47) versus 34 (16-71) weeks, (p = .052). CONCLUSION: AS CS leads had improved electromechanical stability compared with passive fixation leads, with only minimal increases in implant procedure and fluoroscopy times.

Leadless left ventricular endocardial pacing in nonresponders to conventional cardiac resynchronization therapy.

BACKGROUND: Endocardial pacing may be beneficial in patients who fail to improve following conventional epicardial cardiac resynchronization therapy (CRT). The potential to pace anywhere inside the left ventricle thus avoiding myocardial scar and targeting the latest activating segments may be particularly important. The WiSE-CRT system (EBR systems, Sunnyvale, CA) reliably produces wireless, endocardial left ventricular (LV) pacing. The purpose of this analysis was to determine whether this system improved symptoms or led to LV remodeling in patients who were nonresponders to conventional CRT. METHOD: An international, multicenter registry of patients who were nonresponders to conventional CRT and underwent implantation with the WiSE-CRT system was collected. RESULTS: Twenty-two patients were included; 20 patients underwent successful implantation with confirmation of endocardial biventricular pacing and in 2 patients, there was a failure of electrode capture. Eighteen patients proceeded to 6-month follow-up; endocardial pacing resulted in a significant reduction in QRS duration compared with intrinsic QRS duration (26.6 ± 24.4 ms; P = .002) and improvement in left ventricular ejection fraction (LVEF) (4.7 ± 7.9%; P = .021). The mean reduction in left ventricular end-diastolic volume was 8.3 ± 42.3 cm3 (P = .458) and left ventricular end-systolic volume (LVESV) was 13.1 ± 44.3 cm3 (P = .271), which were statistically nonsignificant. Overall, 55.6% of patients had improvement in their clinical composite score and 66.7% had a reduction in LVESV ≥15% and/or absolute improvement in LVEF ≥5%. CONCLUSION: Nonresponders to conventional CRT have few remaining treatment options. We have shown in this high-risk patient group that the WiSE-CRT system results in improvement in their clinical composite scores and leads to LV remodeling.

Shared decision-making for ICDs: a regional collaborative initiative.

The National Institute for Health and Care Excellence (NICE) and NHS England have shown a commitment to embedding shared decision-making (SDM) in clinical practice and developing decision aids based on clinical guidelines. Healthcare policy makers are keen to enhance the engagement of patients in SDM in the belief that it improves the benefits accrued from healthcare interventions. This may be important for interventions such as implantable cardioverter-defibrillator (ICD) implantation, where cost-effectiveness is under scrutiny. NHS England invited the ICD implanters in the north of England to participate in a regional commissioning quality incentive (CQUIN) project to improve decision- making around a primary prevention ICD implant. A collaborative project included the development of a specific SDM tool, the first of its kind in the UK, followed by training and education of the clinical teams. The project illustrates that this approach is practical and deliverable and could be applied and used in other regions, and considered in additional clinical areas.

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

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

Guidance for Optimal Site Selection of a Leadless Left Ventricular Endocardial Electrode Improves Acute Hemodynamic Response and Chronic Remodeling.

OBJECTIVES: This study hypothesized that guided implants, in which the optimal left ventricular endocardial (LVENDO) pacing location was identified and targeted, would improve acute markers of contractility and chronic markers of cardiac resynchronization (CRT) response. BACKGROUND: Biventricular endocardial (BiVENDO) pacing may offer a potential benefit over standard CRT; however, the optimal LVENDO pacing site is highly variable. Indiscriminately delivered BiVENDO pacing is associated with a reverse remodeling response rate of between 40% and 60%. METHODS: Registry of centers implanting a wireless, LVENDO pacing system (WiSE-CRT System, EBR Systems, Sunnyvale, California); John Radcliffe Hospital (Oxford, United Kingdom), Guy's and St. Thomas' Hospital (London, United Kingdom), and The James Cook University Hospital (Middlesbrough, United Kingdom). Centers used a combination of preprocedural imaging and electroanatomical mapping the identify the optimal LVENDO site. RESULTS: A total of 26 patients across the 3 centers underwent a guided implant. Patients were predominantly male with a mean age of 68.8 ± 8.4 years, the mean LV ejection fraction was 34.2 ± 7.8%. The mean QRS duration was 163.8 ± 26.7 ms, and 30.8% of patients had an ischemic etiology. It proved technically feasible to selectively target and deploy the pacing electrode in a chosen endocardial segment in almost all cases, with a similar complication rate to that observed during indiscriminate BiVENDO. Ninety percent of patients met the definition of echocardiographic responder. Reverse remodeling was observed in 71%. CONCLUSIONS: Guided endocardial implants were associated with a higher degree of chronic LV remodeling compared with historical nonguided approaches.

Pacemaker implantation in superior vena cava obstruction: Re-canalization, venoplasty, and stenting.

Techniques to overcome challenging venous anatomy have become an increasingly important part of modern day cardiac device implantation. Complete superior vena cava (SVC) obstruction, however, is a rare and serious clinical entity, and consequently there is limited clinical experience in addressing this pathology in the context of transvenous pacemaker implantation. We present the case of a 48-year-old renal transplant patient with sick sinus syndrome and recurrent syncope, who had an upper SVC occlusion and a failed epicardial pacing system. The SVC was re-canalized and stented using techniques derived from chronic total occlusion coronary angioplasty, thus allowing successful implantation of a transvenous pacemaker lead. This case highlights the increased risk of developing central venous occlusion that exists in renal dialysis patients, and demonstrates the benefits of utilizing transferable interventional coronary and radiology techniques to overcome this pathology and facilitate pacemaker implantation. .

The 7-year teesside experience of primary prevention ICD indications following primary PCI (PPCI) and the potential impact of a change in NICE guidance.

INTRODUCTION: The recovery of LV function in patients with severe LV impairment in the acute phase following primary percutaneous coronary intervention (PPCI) is not well established. The indication for a primary prevention ICD post-STEMI is dependent on which screening guidance, NICE or ESC, is followed. The potential impact of the new NICE guidance is estimated. METHODS: We performed a retrospective analysis of all patients presenting with a STEMI over a 7-year period (2005-2012) treated with PPCI to determine in-hospital mortality, LV function at index presentation, at 3 months and the predicted primary prevention ICD implantation rate using NICE (TA095) and ESC 2006 guidelines. Predicted implant rates using the new NICE guidance (TA314) and actual implantation rates were also assessed. RESULTS: 3902 patients with a mean age of 65±13 years underwent PPCI. Of those patients surviving until discharge, 332 (10%) had LVEF ≤35%. 254 of 332 patients (76%) with a severely impaired ventricle were followed up at participating centres. 210 of 254 (83%) patients had a repeat echocardiogram within 3 months post-MI; among these patients, 89 (42%) remained to have LVEF ≤35%. The number of patients fulfilling NICE and ESC criteria for primary prevention ICD implantation was 14 (16%) and 84 (94%), respectively. The actual number of patients receiving an ICD was 17 (19%). The number of patients fulfilling the new NICE (TA314) guidance was 84 (94%). CONCLUSIONS: A small proportion of patients with STEMIs undergoing PPCI have a severely impaired LV systolic function. A large proportion of these patients will have improved LV systolic function at 3 months. There is a five-fold difference in the predicted ICD implantation rates depending on which guidance is followed-NICE versus ESC. The potential impact of the new NICE (TA314) guidance on ICD implantation will be a significant increase in ICD implantation rates.

Video-assisted thoracoscopic left ventricular pacing in patients with and without previous sternotomy.

BACKGROUND: Left ventricular epicardial lead placement via video-assisted thoracoscopy (VAT) is a recognized surgical technique to achieve cardiac resynchronization therapy (CRT) when conventional lead placement has failed. Its role in patients with previous sternotomy is uncertain. We describe our experience in a cohort of patients including those with previous sternotomy. METHODS: This was a retrospective review of consecutive patients undergoing VAT lead implantation for CRT in a single center between 2004 and 2011. All patients fulfilled conventional criteria for CRT and were followed up at 4 to 6 weeks and then at 3-month intervals. Clinical and pacing parameters were compared at baseline and at the latest review. RESULTS: Thirty-two patients (27 men; mean age, 67 ± 9 years) underwent VAT left ventricular lead implantation. Mean follow-up duration was 704 ± 450 days. Ten patients (31%) had undergone previous sternotomy. Thoracoscopic lead implantation was successful in 31 patients (97%): 1 patient with two previous sternotomies required conversion to open thoracotomy due to bleeding with multiple adhesions. Satisfactory implantation pacing thresholds of 2 volts or less at 0.5 ms were achieved in all patients. Despite a longer operative time in those with previous sternotomy, all clinical and pacing outcomes, including complications, clinical response to CRT, and long-term pacing variables were similar between the groups. CONCLUSIONS: VAT left ventricular lead placement appears safe and effective in selected patients with previous sternotomy, including coronary artery bypass operations, with postoperative outcomes comparable with those patients without previous sternotomy.

Do implantable cardioverter defibrillators improve survival in patients with severe left ventricular systolic dysfunction after coronary artery bypass graft surgery?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether implantable cardioverter defibrillators (ICD) improve survival in patients with severe left ventricular systolic dysfunction (LVSD) after coronary artery bypass graft (CABG) surgery. ICDs are designed to terminate potentially fatal cardiac tachyarrhythmias. A right ventricular lead is mandatory for detection, pacing and defibrillation capabilities. Dual chamber ICDs have an additional right atrial lead and are used for patients with conventional atrioventricular pacing indications. More sophisticated, biventricular devices exist to provide cardiac resynchronisation therapy (CRT) in addition to defibrillation (CRT-D). ICDs have been extensively investigated in patients with LVSD post myocardial infarction and in patients with non-ischaemic cardiomyopathy for both secondary prevention (history of ventricular arrhythmias) and primary prevention (deemed high risk for ventricular arrhythmias). This best evidence topic aims to review the evidence and its applicability to patients post CABG. Nine hundred and sixteen papers were identified using the search method outlined. Eight randomised controlled trials, two meta-analyses, and one non-randomised trial, in addition to international guidelines presented the best evidence to answer the clinical question. The current evidence base and guidelines suggest that ICDs should be considered for all patients with LVSD [ejection fraction (EF) ≤30-40%] receiving optimal pharmacological management, who are ≥40 days post MI [four weeks for National Institute for Health and Clinical Excellence (NICE)] and in New York Heart Association (NYHA) class I-III. UK NICE guidelines require in addition; non-sustained ventricular tachycardia (NSVT) on a Holter monitor and inducible ventricular tachycardia at electrophysiological study for EF between 30 and 35%; or a QRS >120 ms if EF <30%. The North American guidelines recommend EF <30% as a threshold for those with NYHA class I symptoms. The evidence is applicable to patients post CABG, provided all the other criteria are met. European Society of Cardiology (ESC) guidelines recommend waiting at least three months (consensus opinion) after revascularisation prior to assessment for an ICD, to allow time for potential recovery of ventricular function.

In patients undergoing aortic valve replacement, what factors predict the requirement for permanent pacemaker implantation?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question was to determine what preoperative, perioperative and postoperative factors influence the requirement for permanent pacemaker (PPM) implantation postisolated aortic valve replacement (AVR). Transcatheter aortic valve intervention was not included in this analysis. Using the reported search method outlined below, 705 papers were found. No randomised controlled trials, meta-analyses or registries were identified. Seven single-centre retrospective observational studies represent the best evidence on the subject. The author, journal, date and country of publication, level of evidence, patient group studied, study type, outcomes and results were tabulated. The incidence of PPM implantation following AVR varied from 3.0% to 11.8% (mean 7.0%, median 7.2%). Current best available evidence suggests that baseline evidence of conducting system disease - first degree atrioventricular block (AVB), left anterior hemiblock, right bundle branch block (RBBB) or left bundle branch block (LBBB) is the most powerful independent predictor of PPM requirement following AVR. Other important predictors are surgery for aortic regurgitation, preoperative myocardial infarction and longer perioperative cardiopulmonary bypass time. No consistent postoperative factors were identified. The mean time to PPM implant postAVR ranged from 6 to 13 days in the four studies that reported it. Current European Society of Cardiology guidelines recommend a period of seven days of persistent AVB postsurgery prior to PPM implantation.

Postoperative permanent pacemaker implantation in patients undergoing trans-catheter aortic valve implantation: what is the incidence and are there any predicting factors?

A best evidence topic was written according to a structured protocol. The issue was to determine the incidence and predictors of postoperative permanent pacemaker (PPM) implantation in patients undergoing trans-catheter aortic valve implantation (TAVI) for symptomatic calcific aortic stenosis and to compare this to the known risks of this complication following surgical aortic valve replacement (AVR). Using the reported search method 3071 articles were identified, of which 94 were relevant to the procedure of TAVI and 14 were deemed to represent the best evidence. All 14 studies, including both multi-centre registries and single-centre retrospective case series containing ≥30 patients, reported incidence of postoperative PPM implantation. Five of these studies also assessed predictors of the need for postoperative PPM implantation. The author, journal, date and country of publication, study type, level of evidence, patient group, outcomes and results were tabulated for these studies. We conclude that the current best available evidence suggests that the mean incidence of PPM implantation following TAVI is 14.2% (range 0-34%, median 9.7%), although this appears higher with the CoreValve prosthesis (five studies, mean 20.8%, range 9.3-30.0%) than with the Edwards-Sapien prosthesis (six studies, mean 5.4%, range 0-10.1%). The mean incidences of PPM implantation overall and when using the CoreValve prosthesis are higher than the mean incidence of 7.0% (range 3-11.8%, median 7.2%) following conventional AVR and may be explained by distinct differences between the patient groups involved and the procedure performed. Indications for PPM implantation appear to occur early in the postoperative period following TAVI and there is little evidence of recovery following atrioventricular block (AVB). New onset persistent left bundle branch block is common following TAVI but the significance and follow-up required is unclear. Independent predictors of PPM requirement following TAVI include use of the CoreValve prosthesis and evidence of conduction system dysfunction, either pre-existing right bundle branch block or AVB at the time of TAVI. All patients should be made aware of the high risk of PPM implantation with TAVI.

Acquired supravalvular aortic stenosis: a late complication of replacement of the ascending aorta.

Aortic syndromes are an increasing cause of morbidity and mortality. Ascending aortic dissection is a clinical emergency with most patients requiring open surgery to replace the ascending aorta. Detection through clinical suspicion, improved non-invasive imaging and refined surgical techniques have resulted in an improved survival rate. Acquired supravalvular aortic stenosis is an extremely rare complication of cardiac surgery. We present the case of a patient who, 15 years after undergoing elective replacement of the ascending aorta for aortic dissection, required repeat surgery for symptomatic supravalvular aortic stenosis. This case elegantly highlights the need for a detailed focused assessment in patients where the clinical presentation does not correlate with initial investigations. To our knowledge this is the first reported case of late symptomatic supravalvular aortic stenosis following replacement of the ascending aorta.

Does cardiac resynchronisation therapy improve survival and quality of life in patients with end-stage heart failure?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether bi-ventricular pacing, also referred to as cardiac resynchronisation therapy (CRT), improves survival and quality of life in patients with severe (NYHA III/IV) symptomatic heart failure. Cardiac pacing can be achieved by stimulation of the right ventricle, left ventricle (LV) or by bi-ventricular pacing. This best evidence topic considers only bi-ventricular pacing. This involves placement of pacing leads in the right ventricle, epicardially on the LV with a lead typically placed in a branch of the coronary sinus and, unless the patient is in permanent atrial fibrillation, in the right atrium. Bi-ventricular pacing allows the optimisation of atrio-ventricular timing and resynchronisation of septal and postero-lateral left ventricular contraction. Symptomatic heart failure has a high morbidity and a poor prognosis. Patients with dyspnoea at rest or on minimal exertion (NYHA III/IV) are at high risk of death due to progressive heart failure, while those with less severe symptoms are more likely to experience sudden cardiac death. Up to 50% of patients with NYHA class III/IV symptoms have a prolonged QRS duration (>120 ms) on 12-lead ECG (usually in a LBBB pattern). This intra-ventricular conduction delay is a surrogate marker of mechanical dyssynchrony (an uncoordinated regional contraction-relaxation pattern) and is associated with reduced cardiac output and increased mortality. Bi-ventricular pacing can reduce the delay in activation of the LV free wall found in many patients with LV systolic dysfunction, thereby improving mechanical synchrony and cardiac output. It may also reduce pre-systolic mitral regurgitation. Three hundred and fifty-six papers were identified using the search method outlined, nine randomised controlled trials and a meta-analysis in addition to published guidelines presented the best evidence to answer the clinical question. Current best available evidence suggests that in patients with left ventricular systolic dysfunction (LVEF or=120 ms), and NYHA class III or IV symptoms despite optimal pharmacological therapy, bi-ventricular pacing significantly reduces the number of hospitalisations from heart failure, improves functional status (NYHA class, peak oxygen uptake and exercise tolerance) and improves health related quality of life. The CARE-HF study also demonstrated a reduction in mortality from progressive heart failure and all-cause mortality.

Secondary prevention following coronary artery bypass grafting has improved but remains sub-optimal: the need for targeted follow-up.

A focused review of secondary preventive medication following revascularisation provides an opportunity to ensure optimal use of these agents. A retrospective analysis of our in-house cardiothoracic surgical database was performed to identify patients undergoing non-emergency, elective surgical revascularisation discharged on four secondary preventive medications: aspirin; beta-blockers; ACE-inhibitors and statins. Of 2749 patients studied, 2302 underwent isolated coronary artery bypass grafting (CABG), mean age 65.5 years (S.D. 9.15). Overall, 2536 (92%) patients were prescribed aspirin. Beta-blockers were prescribed in 2171 (79%) patients overall, in 1096/1360 (81%) of patients with a history of myocardial infarction and in 465/619 (75%) of patients with left ventricular systolic dysfunction (LVSD). Overall, 1518 (55%) patients were prescribed an ACE-inhibitor and 179 (6.5%) an angiotensin receptor blocker (ARB); one of these agents was prescribed in 446/619 (72%) patients with LVSD and 915/1360 (67%) patients with a history of previous myocardial infarction. Overall, 2518 (92%) patients were prescribed a statin. Secondary preventive therapies are prescribed more commonly on discharge after CABG than in previous studies, but there is a continuing under-utilisation of ACE-inhibitors. To maximise the potential benefits of these agents, further study is required to understand why they are not prescribed.