Completely epicardial implantable cardioverter/defibrillator (ICD) and CRT-D systems: A case series and systematic literature review.

BACKGROUND: Epicardial ICD systems and CRT-Ds using high voltage coils represent an alternative to transvenous systems in patients without central venous access and prior device complications including infection. OBJECTIVE: We present a case series in the adult population of epicardial ICD/CRTD systems using high voltage epicardial coils. We summarize the existing data regarding techniques, efficacy, and safety. METHODS: A retrospective board approved medical record review was conducted for all patients undergoing epicardial ICD/CRTD placement at our institution between January 2010 and May 2020. The literature was reviewed for prior published trials, case reports, and case series of epicardial high voltage coil insertions. RESULTS: Eleven patients (six female, mean age 48 years) underwent epicardial ICD/CRTD implant including 5/11 completely epicardial CRTD systems. The procedure was performed via median sternotomy in eight patients, left anterior thoracotomy in two patients, and sub-xiphoid approach in one patient. After a mean follow up of 35 months, appropriate successful shocks were delivered in two (18%) patients and no patients received an inappropriate shock. Three of five (60%) patients had volumetric remodeling with CRT with significant improvement of LV EF. Device-related complications requiring a surgical/percutaneous revision or another DFT test occurred in six patients (54%). One patient died during follow up due to refractory heart failure. No cases of epicardial device infection, coronary artery compression, constrictive pericarditis, or erosion of defibrillator coils into intrathoracic organs were reported. No randomized studies comparing safety and efficacy of traditional transvenous or subcutaneous ICD systems and epicardial ICD systems using contemporary high voltage coils were found nor any studies directly comparing epicardial defibrillator patches versus epicardial coils. Thirteen case series and 24 single case reports published between 2004 and 2020 were identified describing in total a heterogenous group of 188 patients with ICD systems incorporating one or more epi- or pericardially positioned shock coils. CONCLUSION: The use of epicardial defibrillation coils for ICD/CRT-D is a feasible treatment option for patients with either failed or contraindicated transvenous ICD systems. Dedicated epicardial high voltage leads with integrated pace-sense electrodes and specialized delivery tools for minimal invasive implantations may improve longer term outcomes.

Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.

Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.

Prolonged lead dwell time and lead burden predict bailout transfemoral lead extraction.

BACKGROUND: Transvenous lead extraction (TLE) may be performed by superior approach using the original implant vein or via a femoral approach; however, limited comparative data exists. We compare outcomes between femoral versus nonfemoral TLE approaches and determine predictors of bailout transfemoral lead extraction in patients undergoing initial TLE via the original implant vein by a superior approach. METHODS: All consecutive TLEs between October 2000 and March 2018 were prospectively collected (n = 1052). Patients were dichotomized into femoral (n = 118) and nonfemoral (n = 934) groups. RESULTS: Demographics were balanced between femoral vs nonfemoral groups. Patients in the femoral group had significantly higher mean lead dwell times (11.6 ± 9.7 vs 6.6 ± 6.6 years, P < .001), mean number of leads extracted (2.7 ± 1.3 vs 2.0 ± 1.0, P < .001), 30-day procedure related major complications (including deaths) (8.5% vs 1.1%, P < .001) and emergency thoracotomy rates (4.2% vs 0.7%, P = .007). All-cause 30-day mortality rates were similar between groups (3.4% vs 2.0%, P = .315). Prolonged lead dwell time and increased number of leads extracted were predictive of a bailout transfemoral approach at multivariable analysis. CONCLUSION: Femoral approach TLE is associated with increased risk of 30-day procedure related major complications but not 30-day all-cause mortality. Prolonged lead dwell time and increased number of leads extracted are independent predictors for bailout transfemoral lead extraction. Such patients should be considered high risk of major complications and performed by high-volume lead extraction centers with experience in multiple approaches and techniques including experience with transfemoral lead extraction.

Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis.

Background: CONVERGE was a prospective, multicenter, randomized controlled trial that evaluated the safety of Hybrid Atrial Fibrillation Convergent (HC) and compared its effectiveness to endocardial catheter ablation (CA) for the treatment of persistent atrial fibrillation (PersAF) and longstanding PersAF (LSPAF). In 2020, we reported that CONVERGE met its primary safety and effectiveness endpoints. The primary objective of the present study is to report CONVERGE trial results for quality of life (QOL) and Class I/III anti-arrhythmic drug (AAD) utilization following HC. Methods: Eligible patients had drug-refractory symptomatic PersAF or LSPAF and a left atrium diameter ≤6.0 cm. Enrolled patients were randomized 2:1 to receive HC or CA. Atrial Fibrillation Severity Scale (AFSS) and the 36-Item Short Form Health Survey (SF-36) were assessed at baseline and 12 months; statistical comparison was performed using paired t-tests. AAD utilization at baseline through 12 and 18 months post-procedure was evaluated; statistical comparison was performed using McNemar's tests. Results: A total of 153 patients were treated with either HC (n=102) or CA (n=51). Of the 102 HC patients, 38 had LSPAF. AFSS and SF-36 Mental and Physical Component scores were significantly improved at 12 months versus baseline with HC overall and for the subset of LSPAF patients treated with either HC or CA. The proportion of HC patients (n=102) who used Class I /III AADs at 12 and 18 months was significantly less (33.3% and 36.3%, respectively) than baseline (84.3%; P<0.001). In LSPAF patients who underwent HC (n=38), AADs use was 29.0% through 18 months follow-up versus 71.1% at baseline (P<0.001). Conclusions: HC reduced AF symptoms, significantly improved QOL, and reduced AAD use in patients with PersAF and LSPAF. ClinicalTrialsgov Identifier: NCT01984346.

Hybrid epicardial-endocardial ablation for long-standing persistent atrial fibrillation: A subanalysis of the CONVERGE Trial.

Background: Favorable clinical outcomes are difficult to achieve in long-standing persistent atrial fibrillation (LSPAF) with catheter ablation (CA). The CONVERGE (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent Atrial FIbrillation) trial evaluated the effectiveness of hybrid convergent (HC) ablation vs endocardial CA. Objective: The study sought to evaluate the safety and effectiveness of HC vs CA in the LSPAF subgroup from the CONVERGE trial. Methods: The CONVERGE trial was a prospective, multicenter, randomized trial that enrolled 153 patients at 27 sites. A post hoc analysis was performed on LSPAF patients. The primary effectiveness was freedom from atrial arrhythmias off new or increased dose of previously failed or intolerant antiarrhythmic drugs (AADs) through 12 months. The primary safety endpoint was major adverse event incidence through 30 days with HC. Key secondary effectiveness measures included (1) percent of patients achieving ≥90% AF burden reduction vs baseline and (2) AF freedom. Results: Sixty-five patients (42.5% of total enrollment) had LSPAF; 38 in HC and 27 in CA. Primary effectiveness was 65.8% (95% confidence interval [CI] 50.7%-80.9%) with HC vs 37.0% (95% CI 5.1%-52.4%) with CA (P = .022). Through 18 months, these rates were 60.5% (95% CI 50.0%-76.1%) with HC vs 25.9% (95% CI 9.4%-42.5%) with CA (P = .006). Secondary effectiveness rates were higher than CA with HC at 12 and 18 months. Freedom from atrial arrhythmias off AADs was 52.6% (95% CI 36.8%-68.5%) and 47.4% (95% CI 31.5%-63.2%) with HC at 12 and 18 months vs 25.9% (95% CI 9.4%-42.5%) and 22.2% (95% CI 6.5%-37.9%) with CA, respectively (12 months: P = .031; 18 months: P = .038). Three (7.9%) major adverse events occurred within 30 days of HC. Conclusion: Post hoc analysis demonstrated effectiveness and acceptable safety of HC compared with CA in LSPAF.

Staphylococcus Aureus Infective Endocarditis: JACC Patient Pathways.

A 19-year-old female patient presented with Staphylococcus aureus infective endocarditis, with suspected subdural brain hemorrhage, disseminated intravascular coagulopathy, and septic renal as well as spleen infarcts. The patient had extensive vegetations on the mitral and tricuspid valves and underwent urgent mitral and tricuspid repair. This paper discusses the clinical case and current evidence regarding the management and treatment of Staphylococcus aureus endocarditis.

Staphylococcus Aureus Infective Endocarditis: JACC Patient Pathways.

A 19-year-old female patient presented with Staphylococcus aureus infective endocarditis, with suspected subdural brain hemorrhage, disseminated intravascular coagulopathy, and septic renal as well as spleen infarcts. The patient had extensive vegetations on the mitral and tricuspid valves and underwent urgent mitral and tricuspid repair. This paper discusses the clinical case and current evidence regarding the management and treatment of Staphylococcus aureus endocarditis.

Convergent ablation for persistent atrial fibrillation: outcomes from a single-centre real-world experience.

OBJECTIVES: Atrial fibrillation (AF) is common and can cause significant morbidity and detriment to quality of life. Success rates for conventional catheter ablation are suboptimal in persistent AF (PsAF), especially when longstanding. Convergent hybrid ablation combines endoscopic surgical epicardial and endocardial catheter ablation. It offers promise in treating PsAF. We aimed to evaluate outcomes at our centre following convergent ablation. METHODS: We conducted an observational study of patients undergoing ablation from 2012 to 2019 at a London cardiac centre. Sixty-seven patients underwent convergent ablation entailing epicardial ablation, mostly via sub-xiphoid access, followed by endocardial left atrial catheter ablation. Baseline and follow-up data were obtained retrospectively from clinical records. Primary outcome was freedom from AF on/off anti-arrhythmic drugs after 12-month follow-up. Secondary outcomes included freedom from AF over the entire follow-up, freedom from anti-arrhythmic drugs, freedom from atrial arrhythmias, symptom status, repeat ablation and complications. RESULTS: At baseline, 80.6% had PsAF >1 year (80.6%), 49.3% had body mass index >30 kg/m2 at baseline and 19.4% had left ventricular ejection fraction of 40% or less. The median follow-up was 2.3 (1.4-3.7) years. Freedom from AF recurrence was 81.3% at 1 year and 61.5% over overall follow-up. Eleven patients (16.4%) required redo AF ablation. Prolonged AF duration was associated with increased recurrence at 12 months and duration >5 years with a shorter time to recurrence on Kaplan-Meier analysis, but this and other factors did not significantly impact the AF recurrence during the overall follow-up period. CONCLUSIONS: Convergent ablation had good 1-year and overall success rates for treating PsAF. Our results in a diverse, real-world population support the potential of convergent ablation in patients with challenging to treat PsAF.

Management of Patients With Severe Mitral Annular Calcification: JACC State-of-the-Art Review.

Mitral annular calcification (MAC) is a common and challenging pathologic condition, especially in the context of an aging society. Surgical mitral valve intervention in patients with MAC is difficult, with varying approaches to the calcified annular anatomy, and the advent of transcatheter valve interventions has provided additional treatment options. Advanced imaging provides the foundation for heart team discussions and management decisions concerning individual patients. This review focuses on the prognosis of, preoperative planning for, and management strategies for patients with MAC.

Massive thrombi on an implantable cardioverter-defibrillator lead in a patient with the antiphospholipid syndrome.

A patient with the antiphospholipid syndrome, who was suboptimally anticoagulated, presented with two large thrombi attached to her implantable cardioverter-defibrillator lead. Anticoagulation was unsuccessful so, in view of the risk from embolization, the system was removed surgically and an epicardial system implanted to reduce the risk of future device-related thrombosis.

Percutaneous lead and system extraction in patients with cardiac resynchronization therapy (CRT) devices and coronary sinus leads.

BACKGROUND: Cardiac resynchronization therapy (CRT) device and coronary sinus (CS) lead extraction is required due to the occurrence of system infection, malfunction, or upgrade. Published series of CS lead extraction are limited by small sample sizes. We present a 10-year experience of CRT device and CS lead extraction. METHODS: All lead extractions between 2000 and 2010 were entered into a computer database. From these, a cohort of 71 cases involving a CRT device or CS lead was analyzed for procedural method, success, and complications. RESULTS: Sixty coronary sinus leads were extracted in 71 cases (median age 71 years; 90% male) by manual traction/locking stylets (n = 54) or using a laser sheath (n = 6). Procedural success was achieved in 98% of CS leads. A total of 143 non-CS leads were extracted, with laser required in 46% of cases. The mean duration of lead implantation was 35.8 months (range 1-116 months) and 2.86 ± 1.07 leads were extracted per case. CRT extraction case load increased significantly over time. Minor complications occurred in four (5.6%) cases and major complications in one (1.4%) case. There were no intraprocedural deaths, but two deaths occurred within 30 days of extraction. CONCLUSIONS: Our 10-year experience confirms that percutaneous removal of CS leads can be achieved with high procedural success. Our recorded complication rates are no higher than those of non-CS lead extraction series, and should be taken in the context of the frail nature of CRT patients. Ongoing audit of procedure success and complications will be required to further guide best practice in CS lead extraction.

Long-term survival following transvenous lead extraction: Importance of indication and comorbidities.

BACKGROUND: Long-term outcomes are poorly understood, and data in patients undergoing transvenous lead extraction (TLE) are lacking. OBJECTIVE: The purpose of this study was to evaluate factors influencing survival in patients undergoing TLE depending on extraction indication. METHODS: Clinical data from consecutive patients undergoing TLE in the reference center between 2000 and 2019 were prospectively collected. The total cohort was divided into groups depending on whether there was an infective or noninfective indication for TLE. We evaluated the association of demographic, clinical, and device-related and procedure-related factors on mortality. RESULTS: A total of 1151 patients were included. Mean follow-up was 66 months, and mortality was 34.2% (n = 392). Of these patients, 632 (54.9%) and 519 (45.1%) were for infective and noninfective indications, respectively. A higher proportion in the infection group died (38.6% vs 28.5%; P <.001). In the total cohort, multivariable analysis demonstrated increased mortality risk with age >75 years (hazard ratio [HR] 2.98; 95% confidence interval [CI] 2.35-3.78; P <.001), estimated glomerular filtration rate <60 mL/min/1.73 m2 (HR 1.67; 95% CI 1.31-2.13; P <.001), higher cumulative comorbidity (HR 1.17; 95% CI 1.09-1.26; P <.001), reduced risk per percentage increase in left ventricular ejection fraction (HR 0.98; 95% CI 0.97-0.99; P <.001), and near unity per year of additional lead dwell time (HR 0.98; 95% CI 0.96-1.00; P = .037). Kaplan-Meier survival curves demonstrated worse prognosis, with a higher number of leads extracted and increasing comorbidities. CONCLUSION: Long-term mortality for patients undergoing TLE remains high. Consensus guidelines recommend evaluating risk for major complications when determining whether to proceed with TLE. This study suggests also assessing longer-term outcomes when considering TLE in those with a high risk of medium- and long-term mortality, particularly for noninfective indications.

Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial.

BACKGROUND: The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (AF) treatment led to the development of a minimally invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multicenter randomized controlled CONVERGE trial (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent AF) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for persistent and long-standing persistent AF treatment. METHODS: One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent versus CA. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia absent new/increased dosage of previously failed/intolerant class I/III antiarrhythmic drugs through 12 months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6 cm and imposed no limits on AF duration, making it the only ablation trial to substantially include long-standing persistent-AF, that is, 42% patients with long-standing persistent-AF. RESULTS: Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (P=0.036) on/off previously failed antiarrhythmic drugs and in 53.5% (53/99) versus 32.0% (16/50; P=0.0128) respectively off antiarrhythmic drugs. At 18 months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8 and 30 days postprocedure. No deaths, cardiac perforations, or atrioesophageal fistulas occurred. All but one primary safety event resolved. CONCLUSIONS: The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of persistent and long-standing persistent atrial fibrillation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01984346.

Long-Term Outcomes Following Heart Team Revascularization Recommendations in Complex Coronary Artery Disease.

Background The Heart Team ( HT ) comprises integrated interdisciplinary decision making. Current guidelines assign a Class Ic recommendation for an HT approach to complex coronary artery disease ( CAD ). However, there remains a paucity of data in regard to hard clinical end points. The aim was to determine characteristics and outcomes in patients with complex CAD following HT discussion. Methods and Results This observational study was conducted at St Thomas' Hospital (London, UK). Case mixture included unprotected left main, 2-vessel (including proximal left anterior descending artery) CAD , 3-vessel CAD , or anatomical and/or clinical equipoise. HT strategy was defined as optimal medical therapy ( OMT ) alone, OMT +percutaneous coronary intervention ( PCI ), or OMT +coronary artery bypass grafting. From April 2012 to 2013, 51 HT meetings were held and 398 cases were discussed. Patients tended to have multivessel CAD (74.1%), high SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) scores (median, 30; interquartile range, 23-39), and average age 69±11 years. Multinomial logistic regression analysis performed to determine variables associated with HT strategy demonstrated decreased likelihood of undergoing PCI compared with OMT in older patients with chronic kidney disease and peripheral vascular disease. The odds of undergoing coronary artery bypass grafting compared with OMT decreased in the presence of cardiogenic shock and left ventricular dysfunction and increased in younger patients with 3-vessel CAD . Three-year survival was 60.8% (84 of 137) in the OMT cohort, 84.3% (107 of 127) in the OMT + PCI cohort, and 90.2% in the OMT +coronary artery bypass grafting cohort (92 of 102). Conclusions In our experience, the HT approach involved a careful selection process resulting in appropriate patient-specific decision making and good long-term outcomes in patients with complex CAD .

Transcatheter mitral valve replacement in mitral annulus calcification - "The art of computer simulation".

There is considerable interest in transcatheter prosthetic valve treatment for mitral valve disease in high-risk individuals. Although the presence of mitral annular calcium (MAC) may provide an anchoring zone for such devices, results to date have been modest with reported technical failure rates approaching 30% in specialist centers. This in part relates to the risk of left ventricular outflow tract obstruction and device dislodgment but also to the lack of specific imaging guidelines to plan for such procedures. We present the use of finite element analysis and computer simulation based on cardiac CT in three patients with severe MAC in whom transcatheter devices were considered. In the first two cases, the computer simulations were performed after the clinical procedure and were concordant with the clinical outcome. For the third case, computer simulation was performed prior to the clinical procedure. This indicated unsuitability for transcatheter device deployment and a subsequent medical management was adopted. Overall, our initial results suggest that computer simulation may have the potential to improve patient selection for transcatheter mitral valve replacement in the presence of significant MAC.

Objective assessment of technical skills in cardiac surgery.

OBJECTIVE: Reduced training time combined with no rigorous assessment for technical skills makes it difficult for trainees to monitor their competence. We have developed an objective bench-top assessment of technical skills at a level commensurate with a junior registrar in cardiac surgery. METHODS: Forty cardiothoracic surgeons were recruited for the study, consisting of 12 junior trainees (year 1-3), 15 senior trainees (year 4-6) and 13 consultants. The assessment consisted of four key tasks on standardised bench-top models: aortic root cannulation, vein-graft to aorta anastomosis, vein-graft to Left Anterior Descending (LAD) anastomosis and femoral triangle dissection. An expert surgeon was present at each station to provide passive assistance and rate performance on a validated global rating scale giving rise to a total possible score of 40. Three expert surgeons repeated the ratings retrospectively, using blinded video recordings. Data analysis employed non-parametric tests. RESULTS: Both live and video scores differentiated significantly between performances of all groups of surgeons for all four stations (P < 0.01) (median live and video score for LAD; Junior 19,17; Senior 29,22; Consultant 36,28). Correlations between live and blinded rating were high (r = 0.67-0.84; P < 0.001) as was inter-rater reliability between the three expert video raters (alpha = 0.81). CONCLUSIONS: The use of bench-top tasks to differentiate between cardiac surgeons of differing technical abilities has been validated for the first time. Furthermore, it is unnecessary to perform post-hoc video rating to obtain objective data. These measures can provide formative feedback for surgeons-in-training and lead to the development of a competency-based technical skills curriculum.

Nominal size in six bileaflet mechanical aortic valves: a comparison of orifice size and biologic equivalence.

OBJECTIVES: Nominal size remains the standard by which valves are compared, but its relationship with orifice area and the patient tissue annulus diameter may differ according to valve design. The aims of this study were to measure the orifice size and compare biologic equivalence in six bileaflet mechanical heart valve designs. METHODS: The inflow aspect of each of 29 valves was photographed then digitized, and the maximum internal diameter and orifice area were calculated. Biologic equivalence was assessed with a series of machined polypropylene blocks. RESULTS: The orifice area ranged between 159 and 222 mm(2) for the six size 19 valves. The internal diameter ranged from 1.6 to 4.6 mm less than the manufacturer's nominal size. Biologic equivalence assessed from an estimate of tissue annulus diameter with machined blocks ranged from 1.0 and 3.5 mm larger than nominal size for the intra-annular valves. This diameter ranged from 3.5 mm smaller to 1.5 mm larger than nominal size for the supra-annular valves. CONCLUSION: There are major differences between nominal size and biologic equivalence. This may lead to confusion when attempting to make comparisons between different valve designs with the same nominal size. A clearer sizing nomenclature is required and could be based on in vitro assessment of tissue annulus diameter or an alphanumeric code.