18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

Incidence and economics of transvenous ICD lead complications: Implications for tricuspid valve function and interventions.

BACKGROUND: Implantable cardioverter-defibrillators are used globally and are reliable, but complications related to transvenous leads remain a concern. Evidence related to the incidence and costs of those complications is heterogeneous with respect to scope and healthcare system. This analysis aims to create estimates of the incidence and costs of tricuspid valve (TV) complications, lead failures, and lead extractions from a single large real-world data set. METHODS AND RESULTS: This retrospective longitudinal cohort study used the deidentified Medicare Fee for Service administrative claims database. A total of 116 036 patients with de novo transvenous ICD implant were analyzed. Mean hospital costs were $26 903 for tricuspid valve complications, $20 851 for lead failures, and $22 278 for lead extractions. CONCLUSIONS: Transvenous ICD lead complications incur significant costs to patients, hospitals, and payers when they occur. Advancements in lead technology that reduce these complications could bring significant clinical and economic value.

18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I2) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense 18F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.

Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design.

BACKGROUND: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability. METHODS AND RESULTS: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. CONCLUSION: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

Evaluation of a novel mechanical compression device for hematoma prevention and wound cosmesis after CIED implantation.

BACKGROUND: An important complication of cardiac implantable electronic devices (CIED) implantation is the development of hematoma and device infection. OBJECTIVE: We aimed to evaluate a novel mechanical compression device for hematoma prevention and cosmetic outcomes following CIED implantation. METHODS: An open, prospective, randomized, single-center clinical trial was performed in patients undergoing CIED implantation. Patients were randomized to receive a novel mechanical compression device (PressRite, PR) or to receive the standard of care post device implantation. Skin pliability was measured with a calibrated durometer; the surgical site was evaluated using the Manchester Scar Scale (MSS) by a blinded plastic surgeon and the Patient and Observer Scar Scale (POSAS). Performance of PR was assessed through pressure measurements, standardized scar scales and tolerability. RESULTS: From the total of 114 patients evaluated for enrollment, 105 patients were eligible for analysis. Fifty-one patients were randomized to management group (PR) and 54 to the control group. No patients required early removal or experienced adverse effects from PR application. There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS). The control group had higher post procedure durometer readings in the surgical site when compared with the PR group (7.50 ± 3.45 vs. 5.37 ± 2.78; p = < .01). There were lower MSS scores in the PR group after 2 weeks (p = .03). CONCLUSION: We have demonstrated the safety of PR application and removal. In addition, PR appears to improve postoperative skin pliability, which could facilitate wound healing.

The use of non-invasive mapping in persistent AF to predict acute procedural outcome.

BACKGROUND: ECG imaging (ECGI) with phase mapping has been used to identify rotational activity non-invasively that can be targeted during atrial fibrillation (AF) ablation. Acute termination of AF using this method has shown improved clinical outcomes. In this study we sought to evaluate whether patterns of rotational density are associated with acute procedural outcomes when using a step-wise ablation strategy. METHODS: 50 patients with persistent or long-standing persistent AF underwent non-invasive 3D mapping with CardioInsight™ prior to AF ablation. Composite maps of rotational activity were created and prioritized based on the density of rotations on a biatrial model. Stepwise ablation of pulmonary vein isolation (PVI) ±â€¯rotations ± linear lesions was done with AF termination as the procedural endpoint. RESULTS: Acute termination of AF was achieved in 34 patients (68%). Median number of rotations in the left atrium (LA), interatrial septum and right atrium (RA) were 22.2 (9.4 to 29.3), 12.0 (4.3 to 13.4), 25.0 (14.5 to 31.3), respectively. In patients with acute AF termination, a higher number of rotations in the LA was observed, 20.3 (10.0 to 37.1) compared to 10.6 (7.7 to 17.2) in the RA (p = 0.02). Additionally, high density of rotations in the posterior inferior right atrium (segment 2B on the biatrial model) was observed in patients without acute AF termination (p = 0.02). CONCLUSION: Acute termination of persistent and long-standing persistent AF using rotational ablation guided by ECGI phase mapping can be achieved in a high percentage of both index and re-do cases. The distribution and pattern of these rotations may be associated with procedural outcomes and could potentially be used to stratify patients.

Atrial flutter after surgical maze: incidence, diagnosis, and management.

PURPOSE OF REVIEW: The prevalence of atrial fibrillation is increasing and surgical ablation is becoming more common, both as a stand-alone procedure and when performed concomitantly with other cardiac surgery. Although surgical ablation is effective, with it unique challenges arise, including iatrogenic macroreentrant tachycardias that are often highly symptomatic and difficult to manage conservatively. RECENT FINDINGS: Postsurgical ablation, localization of the arrhythmic circuit is difficult to determine using surface ECG alone because of alterations in the atrial myocardium, and multiple different pathways are often present. Most, however, localize to the left atrium, and percutaneous catheter ablation is emerging as an effective treatment modality. SUMMARY: Patients with complex postoperative arrhythmias should be referred to a dedicated atrial fibrillation center when possible and symptomatic arrhythmias mapped and ablated. Knowledge of the previously performed surgical lesion set is of vital importance in understanding the mechanism of the arrhythmia and increasing procedural success rates. VIDEO ABSTRACT: http://links.lww.com/HCO/A31.