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Background Superior vena cava (SVC) tears are rare but potentially lethal complications associated with transvenous lead extraction. When lacerations occur, surgeons need to be prepared for an emergent response. Nonetheless, little is known about the precise whereabouts of these lesions. Understanding the location and injury patterns enables a more anticipated and targeted surgical response. Methods We collected data via physician interviews after an SVC laceration occurred. These physicians were identified through the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and independent physician reports of adverse events. We identified 116 reports of SVC tears between July 1, 2016, and July 31, 2018. For an SVC tear to be included in our registry, a cardiothoracic surgeon had to be physically present to confirm the injury via emergent sternotomy. In each case, the surgeon recorded the SVC injury's exact location after a repair was attempted. Results During the study period, 116 SVC tears were confirmed by sternotomy. Tears occurred in any combination of the following locations: SVC–innominate vein, body of the SVC, and SVC–right atrial junction. The majority of tears (n = 72; 62%) were located in the isolated body of the SVC, followed by the SVC–right atrial junction (n = 23;19.8%) and the SVC–innominate junction (n = 17;14.6%). Combined tears were rare, accounting for only 3.6% (n = 4) of the adverse events recorded. Conclusions Most SVC tears occurred in the isolated body of the SVC. The second most common location was the SVC–right atrial junction. The SVC–innominate junction was the third most common location for these injuries. Combined tears were uncommon.

Aims The aim of this study is to evaluate the incidence, predictors, and outcomes of balloon-related thrombosis (BRT) in patients undergoing transvenous lead extraction (TLE). Use of an endovascular occlusion balloon has improved outcomes of superior vena cava injuries during TLE. Its thrombogenicity in clinical practice is unknown. Methods and results We prospectively evaluated consecutive patients undergoing prophylactic balloon placement during TLE utilizing two procedural workflows: one with the balloon within the inferior vena cava during the entire case (standard cohort) and one limiting the balloon’s dwell time (abbreviated cohort). Intracardiac echocardiography was used to evaluate for significant BRT (thrombus > 1 cm) after TLE. Forty-two patients (21 in each group) were included. Age, left ventricular ejection fraction, procedural indication, number of leads, and lead dwell time were similar between the groups. Balloon dwell time was significantly longer in the standard group (128 ± 74 vs. 25 ± 18 min, P < 0.001) as was BRT (14/21 vs. 1/21, P < 0.001). Mean thrombus length and width in the standard group was 3.99 ± 1.40 and 0.45 ± 0.16 cm, respectively and 5.2 × 0.4 cm in one patient in the abbreviated group. Between patients with and without BRT in the standard group, balloon dwell times were similar (113 ± 64 vs. 156 ± 88 min, P = 0.21). One patient in the standard group had a pulmonary embolism on post-operative Day 3 and was initiated on oral anticoagulation. Conclusion Prophylactic balloon placement for the entirety of the case is associated with a high incidence of BRT; a finding that is decreased when an abbreviated workflow is utilized.

Small vegetations (2.0 cm) associated with infected cardiac device leads can be managed percutaneously, whereas larger vegetations typically are removed via open heart surgery. Unfortunately, many patients with intracardiac vegetations are not candidates for open removal.The purpose of this study was to report our experience in the outcomes associated with the percutaneous management of large vegetations.Prospective data from January 2010 to August 2018 identified 826 patients with infections undergoing lead extraction. One hundred nineteen cases had vegetations measured in 2 dimensions (length and width) by transesophageal echocardiogram. Thirty-two patients had 3 characteristics: (1) at least 1 vegetation dimension ≥2.0 cm; (2) not a surgical candidate; and (3) had undergone transvenous lead extraction. The cohort was classified into 2 groups according to shape: (1) globular if the difference between dimensions was30% between dimensions; and (2) nonglobular if the difference was30%. The Fisher exact test and Pearson t test were used for analysis. P.05 was considered significant.Retrospective analysis of a single tertiary cardiac surgery center registry showed a significantly lower chance of being alive at discharge in patients with globular vegetations compared to patients with nonglobular vegetations (P = .002).Vegetation size is an important determinant of outcomes in patients who are not surgical candidates undergoing transvenous lead extraction. However, vegetation shape is also a relevant factor, as globular vegetations may predict a worse result compared to nonglobular vegetations.

We report the first case of a patient with myxofibrosarcoma (MFS) who presented acutely with a rib fracture and developed a rapidly expanding loculated hemothorax after chest trauma. The patient was taken to the operating room for evacuation of hemothorax, and samples and biopsy specimens were taken for cytologic and pathologic examination. Final report with immunohistochemical staining showed a high-grade MFS. After the procedure, there was clinical and radiological improvement, and the patient was followed up as an outpatient. Myxofibrosarcoma is a very rare and aggressive connective tissue neoplasm with variable presentations. Surgical resection is the preferred treatment. Prompt diagnosis and adequate management of these tumors are important to reduce their high local recurrence and distant metastasis rates. Therefore, it is important to be aware of its common and uncommon presentations.

BACKGROUND We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques. METHODS AND RESULTS This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value

Objectives This study sought to evaluate the impact of abandoned cardiovascular implantable electronic device (CIED) leads on the presentation and management of device-related infections. Background Device infection is a serious consequence of CIEDs and necessitates removal of all hardware for attempted cure. The merits of extracting or retaining presumed sterile but nonfunctioning leads is a subject of ongoing debate. Methods The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled patients with CIED infections at 10 institutions in the United States and abroad between January 1, 2009, and December 31, 2012. Within a propensity-matched cohort, relevant clinical information was compared between patients who had 1 or more abandoned leads at the time of infection and those who had none. Results Matching produced a cohort of 264 patients, including 176 with no abandoned leads and 88 with abandoned leads. The groups were balanced with respect to Charlson comorbidity index, oldest lead age, device type, sex, and race. At the time of admission, those with abandoned leads were less likely to demonstrate systemic signs of infection, including leukocytosis (p = 0.023) and positive blood cultures (p = 0.005). Conversely, patients with abandoned leads were more likely to demonstrate local signs of infections, including skin erosion (p = 0.031) and positive pocket cultures (p = 0.015). In addition, patients with abandoned leads were more likely to require laser extraction (p = 0.010). Conclusions The results of a large prospective registry of CIED infections demonstrated that patients with abandoned leads may present with different signs, symptoms, and microbiological findings and require laser extraction more than those without abandoned leads.

Due to new indications and improved technology, the incidence of laser lead extraction (LLE) has significantly increased over the past years. While LLE has been well studied and proven to be safe and effective, only few studies are geared toward the anesthesiologist's role during high-risk LLEs. This article utilized both a focused review and authors' experience to investigate anesthetic protocols during LLEs. Through this review, we recommend best practices for the anesthesiologist including appropriate procedure location, onsite availability of a cardiac surgeon, availability of a cardiopulmonary bypass machine, and intraoperative use of echocardiography to detect and address potential complications during high-risk LLEs.

Background Many clinicians use the strategy of prophylactically placing an endovascular balloon before transvenous lead extraction, yet there are no data regarding this practice. Objective This study assesses long-term outcomes of prophylactic placement of an endovascular balloon in the venae cavae of patients during transvenous lead extraction. Methods From April 1, 2016 to March 31, 2017 data were prospectively collected at 2 international cardiovascular centers on patients who had the balloon prophylactically placed in the venae cavae. Patients were monitored for a minimum of 3 months to capture any associated adverse events. Results Twenty-one patients had the balloon prophylactically placed in the venae cavae during lead extraction. Sixteen patients were male (76%); the mean age was 57.6 ± 18.7 years; and the mean body mass index was 26.1 ± 4.4 kg/m2. The mean lead dwell time was 11.2 ± 8.3 years, with an average of 2.2 ± 1.1 leads per case, and most indications for extraction were noninfectious (62%). Two minor complications (10%, pocket hematomas) and 1 major complication (5%, cardiac tamponade) occurred during the procedure. All cases (100%) were procedural successes, and all patients (100%) were discharged alive. On follow-up (6.8 ± 3.7 months), all patients were alive and reported no adverse events related to prophylactic balloon placement, such as pulmonary emboli or deep venous thrombi. Conclusion During the study period, we observed no acute or long-term adverse outcomes associated with prophylactic placement of an endovascular balloon in the venae cavae of patients undergoing transvenous lead extraction.

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Background: Lead management is an increasingly important aspect of care in patients with cardiac implantable electronic devices; however, relatively little is known about long-term outcomes after capping and abandoning leads. Methods: Using the 5% Medicare sample, we identified patients with de novo cardiac implantable electronic device implantations between January 1, 2000, and December 31, 2013, and with a subsequent lead addition or extraction ≥12 months after the de novo implantation. Patients who underwent extraction for infection were excluded. Using multivariable Cox proportional hazards models, we compared cumulative incidence of all-cause mortality, device-related infection, device revision, and lead extraction at 1 and 5 years for the extraction versus the cap and abandon group. Results: Among 6859 patients, 1113 (16.2%) underwent extraction, whereas 5746 (83.8%) underwent capping and abandonment. Extraction patients tended to be younger (median, 78 versus 79 years; P P =0.05), and had shorter lead dwell time (median, 3.0 versus 4.0 years; P P =0.027). There was no association between extraction and mortality, lead revision, or lead extraction at 5 years. Conclusions: Elective lead extraction for noninfectious indications had similar long-term survival to that for capping and abandoning leads in a Medicare population. However, extraction was associated with lower risk of device infections at 5 years.

Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair [‡][1] Nancy M. Albert, PhD, CCNS, CCRN, FAHA[§][2] Paul S. Chan, MD, MSc, FACC[‡][1] Lesley H. Curtis, PhD[‡][1] T. Bruce Ferguson, Jr, MD, FACC[§][2] Gregg C. Fonarow, MD, FACC, FAHA[‡][1] Michelle Gurvitz, MD, FACC[§][2] Corrine Y.

Background: Few studies have characterized the surgical outcomes following epicardial pacemaker implantation in neonates with congenital complete atrioventricular block (CCAVB). Objective: This study sought to assess the long-term outcomes of a minimally invasive epicardial approach using a subxiphoid access for pacemaker implantation in neonates. Methods: Between July 2002 and February 2015, 16 consecutive neonates underwent epicardial pacemaker implantation due to CCAVB. Among these, 12 (75.0%) had congenital heart defects associated with CCAVB. The patients had a mean age of 4.7 ± 5.3 days and nine (56.3%) were female. Bipolar steroid-eluting epicardial leads were implanted in all patients through a minimally invasive subxiphoid approach and fixed on the diaphragmatic ventricular surface. The pulse generator was placed in an epigastric submuscular position. Results: All procedures were successful, with no perioperative complications or early deaths. Mean operating time was 90.2 ± 16.8 minutes. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 4.1 ± 3.9 years. Three children underwent pulse generator replacement due to normal battery depletion at 4.0, 7.2, and 9.0 years of age without the need of ventricular lead replacement. There were two deaths at 12 and 325 days after pacemaker implantation due to bleeding from thrombolytic use and progressive refractory heart failure, respectively. Conclusion: Epicardial pacemaker implantation through a subxiphoid approach in neonates with CCAVB is technically feasible and associated with excellent surgical outcomes and pacing lead longevity.

Background: A history of open-heart surgery has been a heavily debated topic in transvenous lead extraction. This study evaluates the impact of prior sternotomy on transvenous lead extraction outcomes. Methods: Data for all patients undergoing transvenous lead extraction at a tertiary referral center were prospectively gathered from 2004 to 2017. Relevant clinical information was compared between patients with a history of sternotomy before transvenous lead extraction and those without. After considering baseline differences, multivariate regression, and propensity-matched analysis were performed. Outcome variables included major and minor complication rates, clinical success, and in-hospital mortality as defined by the 2017 Heart Rhythm Society consensus statement. Results: Of 1480 patients in the study period, 455 had a prior sternotomy. When compared with patients with no prior sternotomy, those with prior sternotomy were more likely to be older, male, and present with more comorbidities and leads targeted for extraction. No statistical differences were identified in major and minor complication rates ( P =0.75, P =0.41), clinical success rate ( P =0.26), and in-hospital mortality ( P =0.08). In patients with prior sternotomy, there were no instances of pericardial effusion after extraction. Prior sternotomy was not an independent predictor of clinical or procedural outcomes. No associations were elucidated after propensity-matched analysis. Conclusions: In a large, single-center series, no differences in clinical or procedural outcomes were elucidated between patients with a history of sternotomy and those without. Patients with sternotomies before lead extraction who experienced vascular or cardiac perforations clinically presented with hemothoraces rather than pericardial effusions.

Background: Superior vena cava (SVC) tears are one of the most lethal complications in transvenous lead extraction. An endovascular balloon can occlude the SVC in the event of a laceration, preventing blood loss and offering a more controlled surgical field for repair. An early study demonstrated that proper use of this device is associated with reduced mortality. Thereafter, high-volume extractors at the Eleventh Annual Lead Management Symposium developed a best practice protocol for the endovascular balloon. Methods: We collected data on adverse events in lead extraction from July 1, 2016, to July 31, 2018. Data were prospectively collected from both a US Food and Drug Administration–maintained database and physician reports of adverse events as they occurred. We gathered case details directly from extracting physicians. Confirmed SVC tears were analyzed for patient demographics, case details, and index hospitalization mortality. Results: From July 1, 2016, to July 31, 2018, 116 confirmed SVC events were identified, of which 44.0% involved proper balloon use and 56.0% involved no use or improper use. When an endovascular balloon was properly used, 45 of 51 patients (88.2%) survived in comparison to 37 of 65 patients (56.9%) when a balloon was not used or improperly used ( P =0.0002). Furthermore, multivariate regression modeling found that proper balloon deployment was an independent, negative predictor of in-hospital mortality for patients who experienced an SVC laceration (odds ratio, 0.13; 95% CI, 0.04–0.40; P Conclusions: From July 1, 2016, through July 31, 2018, patients undergoing lead extraction were more likely to survive SVC tears when treatment included an endovascular balloon.

Background Enterococcal cardiovascular implantable electronic device (CIED) infections are not well characterized. Methods Data from the Multicenter Electrophysiologic Device Infection Cohort, a prospective study of CIED infections, were used for descriptive analysis of adults with enterococcal CIED infections. Results Of 433 patients, 21 (4.8%) had enterococcal CIED infection. Median age was 71 years. Twelve patients (57%) had permanent pacemakers, five (24%) implantable cardioverter defibrillators, and four (19%) biventricular devices. Median time from last procedure to infection was 570 days. CIED-related bloodstream infections occurred in three patients (14%) and 18 (86%) had infective endocarditis (IE), 14 (78%) of which were definite by the modified Duke criteria. IE cases were classified as follows: valvular IE, four; lead IE, eight; both valve and lead IE, six. Vegetations were demonstrated by transesophageal echocardiography in 17 patients (81%). Blood cultures were positive in 19/19 patients with confirmed results. The most common antimicrobial regimen was penicillin plus an aminoglycoside (33%). Antibiotics were given for a median of 43 days. Only 14 patients (67%) underwent device removal. There was one death during the index hospitalization with four additional deaths within 6 months (overall mortality 24%). There were no relapses. Conclusions Enterococci caused 4.8% of CIED infections in our cohort. Based on the late onset after device placement or manipulation, most infections were likely hematogenous in origin. IE was the most common infection syndrome. Only 67% of patients underwent device removal. At 6 months follow-up, no CIED infection relapses had occurred, but overall mortality was 24%.

Background and aim of study The treatment of inoperable patients with concomitant complex coronary artery disease and severe aortic stenosis unsuitable for conventional transcatheter aortic valve replacement (TAVR) poses a significant challenge. Effective treatment is even more difficult in those patients with complex coronary anatomy unamenable to percutaneous revascularization. Our manuscript aims to enlighten clinicians on the management of this complex patient. Methods We conducted a contemporary review of the literature of combined off-pump coronary artery bypass grafting and transaortic TAVR in this patient population and describe our own successful experience in an inoperable patient with a porcelain aorta. Results Including our report, 17 cases have been described in the literature. All patients had multiple comorbidities with elevated STS (range, 2.6-25; 6%) and EuroScore I (range, 13.7-83; 7%) and were not considered candidates for conventional CABG and SAVR. Most had severe, complex, multivessel CAD deemed unsuitable for PCI and structural findings precluding them from other standard percutaneous or alternative TAVR approaches (transfemoral/subclavian/transcaval/transapical). Out of the 17 cases, 5 (29%) had porcelain aortas. Most reports specify the decision-making process is driven by a multidisciplinary team. Conclusion This report demonstrates that hybrid off-pump CABG surgery and transaortic TAVR can be successfully performed in high-risk patients with porcelain aortas who are not candidates for percutaneous methods, on-pump revascularization, transfemoral, subclavian, or transcaval valve implantations. It also highlights that careful study of the CTA scan could predict adequate access for a transaortic approach even in the presence of porcelain aorta in selected patients.

Background Complete heart block is a known complication after transcatheter aortic valve replacement (TAVR), often requiring pacemaker implantation within 24 hours of the procedure. However, clinical markers for delayed progression to complete heart block after TAVR remain unclear. Objectives We examined electrocardiographic data that may correlate with delayed progression to complete heart block and need for pacemaker. Methods This is a single-center retrospective study of 608 patients who underwent TAVR between April 2008 and June 2017. We excluded 164 (27.0%) patients due to having a pacemaker before the procedure or expiring within 24 hours of the procedure (8, 1.3%). We excluded an additional 50 (8.2%) patients who received a pacemaker within 24 hours of the procedure. Electrocardiograms (EKGs) obtained after the procedure were compared to the preprocedural EKG to detect new changes. Results Left bundle branch block, intraventricular conduction delay, left anterior fascicular block, and right bundle branch block were the most commonly seen conduction abnormalities after TAVR (25.1%, 10.9%, 7.5%, and 3.6%, respectively). Both left bundle branch block (odds ratio [OR] = 2.77 [95% confidence interval (CI): 1.24-6.22]) and right bundle branch block (OR = 13.2 [95% CI: 4.18-41.70]) carried an increased risk of pacemaker implantation after TAVR. Additionally, ΔPR greater than 40 ms from baseline also carried an increased risk of pacemaker implantation (OR = 3.53 [95% CI: 1.49-8.37]). Conclusion Left bundle branch block, right bundle branch block, and ΔPR greater than 40 ms were all associated with delayed progression to complete heart block and need for pacemaker implantation after TAVR.

Surgical and hybrid lead extraction has developed considerably over the past several decades. Although transvenous lead extraction is the standard approach to remove infected or malfunctioning cardiac implantable electronic device leads, surgical approaches may be necessary in complex cases not amenable to transvenous lead extraction or in cases that involve concomitant pathologies, such as tricuspid valve regurgitation. We describe our experience with 4 minimally invasive surgical approaches to lead extraction as well as our experience with hybrid open heart surgery and transvenous lead extraction as an option for patients who present with concomitant conditions.

The rise in indications for cardiac implantable electronic devices has necessitated the development of tools for removal of the electrodes that connect the heart to these externally located pacemakers and defibrillators. After implant of a cardiac electrode, variable but progressive fibrous adhesion occurs. Removal of these adhesions can cause devastating complications with high risk of mortality if not treated surgically in a highly expeditious and appropriate manner. This article describes the incidence, risk factors, and diagnosis of these injuries followed by discussion of recent evidence for use of superior vena cava balloon occlusion, and conventional surgical repair of these injuries.

Background With the increasing prevalence of human immunodeficiency virus positive (HIV+) patients in the United States, and the association between HIV and cardiovascular morbidity and mortality, the use of cardiac implantable electronic devices (CIEDs) in patients with HIV has become more common. With the increasing incidence of device-related complications, lead extraction is becoming a topic of importance in this population. As the use of implantable devices increases in the HIV+ population, complications are to be expected; therefore, lead extraction in the HIV population must be addressed. Methods From January 2004 to May 2013, 1,018 patients requiring lead extraction were referred to a single, high-volume tertiary cardiovascular center. Within this group of patients, 10 were HIV+. We retrospectively reviewed the charts of this cohort and reported clinical variables of interest. Results Infection was the most common indication for lead extraction and device removal. Four patients were in advanced heart failure, and the overall average ejection fraction of the sample population was 32.7 ± 16.3%. In addition, the majority of patients had one or more medical comorbidities. Devices removed, in order of frequency, were implantable cardioverter defibrillators, permanent pacemakers, and cardiac resynchronization therapy devices. On average, 35.6 ± 41.6 months elapsed from implantation of the oldest lead to the date of extraction. There were no major or minor complications and all procedures were clinically successful. Conclusions Laser lead extraction is both safe and effective in patients with HIV. This study sets a level of clinical precedent regarding the management of CIED infection or malfunction in patients with HIV.

Transcatheter aortic valve replacement (TAVR) is a well established interventional alternative for severe aortic stenosis. Acute coronary ostia obstruction is a rare but fatal complication of TAVR if it goes unnoticed. 82-year-old female presented to the hospital for acute heart failure

Artificial implantable pacemakers have long been a challenge to neurosurgeons seeking to perform advanced diagnostic imaging on their patients. Unfortunately, while the use of implantable pacemakers has been a life-saving advance for those with cardiac arrhythmias, they also often prevent these patients from undergoing magnetic resonance imaging (MRI). There have been multiple reported cases of pacemaker failure in the context of MRI use. Recent technological advances, however, have allowed the development of pacemakers that are not affected by the MRI scanner. Similar technology has also been applied to the development of MRI-compatible spinal cord stimulators and other neurostimulation devices. In this paper, we discuss four specific neurosurgical cases where the use of MRI was critical for diagnostic and therapeutic decision-making. Current non-MRI-compatible pacemakers were exchanged for MRI-compatible pacemaker technology with some associated cost and risk. The diagnostic cranial and spinal MRIs subsequently obtained were critical for forging the ensuing neurosurgical care. Based on these cases, we extrapolate the importance of MRI-compatible pacemakers to society at large and advocate for the use of such devices in all patients going forward.

The use of cardiac implantable electronic devices (CIEDs) has continued to rise along with indications for their removal. When confronted with challenging clinical scenarios such as device infection, malfunction or vessel occlusion, patients often require the prompt removal of CIED hardware, including associated leads. Recent advancements in percutaneous methods have enabled physicians to face a myriad of complex lead extractions with efficiency and safety. Looking ahead, emerging technologies hold great promise in making extractions safer and more accessible for patients worldwide. This review will provide the most up-to-date indications and procedural approaches for lead extractions and insight on the future trends in this novel field.

Background Cardiac implantable electronic device-related infective endocarditis (CIED-IE) comprises 10–57% of total CIED infections. Patients with definite CIED-IE who fulfill both major modified Duke criteria have not been well characterized. Methods Data from the Multicenter Electrophysiologic Device Infection Cohort, a prospective, multinational study of CIED infections were used to describe a subset of patients with CIED-IE who met both major Duke criteria for definite IE (bloodstream infection and intracardiac vegetations [VEG]). Results Of 433 patients with CIED infection, 144 (33.3%) had definite CIED-IE. The median age was 68 years and 77.1% were male. Twelve (8.3%) had past CIED infection. Seventy-seven patients (53.5%) had permanent pacemakers, 38 (26.4%) had implantable cardioverter defibrillators, and 29 (20.1%) had combination devices. The median time following the last device procedure was 550 days. CIED-IE was early in 60 patients (41.7%) and late in 84 (58.3%). Most patients presented with fever (77.8%) and sepsis (44.4%) with a median symptom duration of 7 days. On echocardiography, lead VEG was noted in 125 patients (86.8%) and valvular VEG in 54 patients (37.5%) with the tricuspid valve involved in 56.5%. On the basis of VEG location, there were 90 patients (62.5%) with isolated lead-associated IE (LAE), 19 patients (13.2%) with isolated valve-associated IE (VAE), and 35 patients (24.3%) with both (LVAE). All patients had positive blood cultures and 63/119 (52.9%) had positive lead cultures. The predominant organism in blood was Staphylococcus aureus (42.4%), followed by coagulase-negative staphylococci (20.1%). CIED removal occurred in 131 patients (91%). There were 25 deaths during the index hospitalization and 34 total deaths (24.3%) by 6 months. Mortality correlated with age >75 (P = 0.023) and sepsis on presentation (P = 0.052). Infecting organism, site of VEG, and device removal did not impact the risk of death. Conclusion Definite CIED-IE is relatively common. The majority of patients tend to have late-onset infection and often present with sepsis. S. aureus is the dominant organism causing definite CIED-IE. Isolated LAE occurs in 63% of patients. Older age and sepsis on admission are associated with higher mortality. Disclosures All authors: No reported disclosures.

Cardiac device lead extractions have increased in frequency over the past several years. Although most of these procedures are successfully performed through a percutaneous approach, certain cases may be unmanageable using conventional methods. The traditional approach for such complex cases has been median sternotomy. However, four surgical techniques offer a less-invasive alternative. These include the transatrial approach, the subxiphoid approach, the left minithoracotomy/thoracoscopy, and the ministernotomy. In the present study, we reviewed data from patients who underwent minimally invasive, surgical lead extraction at our institution from January 2003 to October 2017 using an ongoing, prospective registry. Summary statistics were generated for age, sex, device extracted, lead dwell time (years), procedure indication, major/minor complications and procedural success as defined by the 2017 Heart Rhythm Society consensus statement, and survival at discharge. Between January 2003 and October 2017, 14 cases at our center were managed via a transatrial approach, whereas 11 involved the subxiphoid approach, 19 involved a left minithoracotomy or thoracoscopy, and one involved a ministernotomy. For the transatrial approach, all cases were classified as procedural successes and all patients were discharged alive. Additionally, for the subxiphoid approach, all cases were deemed procedural successes, whereas survival at discharge was 90.9%. For the left minithoracotomy/thoracoscopy, all cases were procedural successes and survival at discharge was 94.7%. Lastly, the ministernotomy was successfully used to remove an infected, retained lead fragment from the innominate vein. In conclusion, at our institution, the transatrial approach, the subxiphoid approach, the left minithoracotomy/thoracoscopy, and the ministernotomy were used as minimally invasive, surgical approaches that represent fairly safe and effective alternatives to median sternotomy in complex cases unamenable to management via conventional, percutaneous approaches to lead extraction.

The rate of cardiovascular implantable electronic device infections (CIEDIs) has mirrored or exceeded the increased use of implantable cardiac devices in the United States. The presence of racial and ethnic disparities associated with CIEDIs has not been published. Our aim is to describe the presence of racial and ethnic disparities with respect to the management of CIEDIs.We reviewed a prospective single-center registry for patients undergoing removal of an implantable cardiac device between 1/2004 and 1/2016. 1173 consecutive patients underwent device extraction. 699 patients were identified as having an infection, 305 were identified as Caucasian and 394 were minorities (91 African Americans, 303 Hispanics). Patients had pre-operative transesophageal echocardiograms (TEEs) and collection of blood and exudate cultures. All underwent complete hardware extraction; leads were removed through the use of locking stylets and traction or laser extraction. En-bloc capsulectomy was performed with intraoperative specimen collection from pocket tissue, exudate, lead tips, and vegetations.Minority patients were: younger (67.9 ± 14.5 years vs 72.4 ± 13.2 years), had a higher proportion of male gender, diabetes, and chronic renal failure (p 0.001). Minorities experienced a higher rate of complications during extraction and a longer hospitalization (15.3 ± 9.9 days versus 17.4 ± 13.4 days, p 0.001). There was no significant difference between the proportion of types of infection in both groups.Minority patients with CIEDIs experienced more procedural complications during extraction and had a significantly longer length of index hospitalization than Caucasian patients.

Background Published guidelines mandate complete device removal in cases of cardiovascular implantable electronic device (CIED) infection. Clinical predictors of successful salvage of infected CIEDs have not been defined. Methods Data from the Multicenter Electrophysiologic Device Infection Collaboration, a prospective, observational, multinational cohort study of CIED infection, were used to investigate whether clinical predictors of successful salvage of infected devices could be identified. Results Of 433 adult patients with CIED infections, 306 (71%) underwent immediate device explantation. Medical management with device retention and antimicrobial therapy was initially attempted in 127 patients (29%). "Early failure" of attempted salvage occurred in 74 patients (58%) who subsequently underwent device explantation during the index hospitalization. The remaining 53 patients (42%) in the attempted salvage group retained their CIED. Twenty-six (49%) had resolution of CIED infection (successful salvage group) whereas 27 patients (51%) experienced "late" salvage failure. Upon comparing the salvage failure group, early and late (N = 101), to the group experiencing successful salvage of an infected CIED (N = 26), no clinical or laboratory predictors of successful salvage were identified. However, by univariate analysis, coagulase-negative staphylococci as infecting pathogens (P = 0.0439) and the presence of a lead vegetation (P = 0.024) were associated with overall failed salvage. Conclusions In patients with definite CIED infections, clinical and laboratory variables cannot predict successful device salvage. Until new data are forthcoming, device explantation should remain a mandatory and early management intervention in patients with CIED infection in keeping with existing expert guidelines unless medical contraindications exist or patients refuse device removal.

Prevention of sudden cardiac arrest (SCA) after removal of an infected implantable cardioverter-defibrillator (ICD) is a challenging clinical dilemma. The cost-effectiveness of the wearable cardioverter-defibrillator (WCD) in this setting remains uncertain.The purpose of this study was to compare the cost-effectiveness of the WCD with discharge home, discharge to a skilled nursing facility, or inpatient monitoring for the prevention of SCA after infected ICD removal.A decision model was developed to compare the cost-effectiveness of use of the WCD to several different strategies for patients who undergo ICD removal. One-way and 2-way sensitivity analyses were performed to account for uncertainties.In the base-case analysis, the incremental cost-effectiveness of the WCD strategy was $20,300 per life-year (LY) or $26,436 per quality-adjusted life-year (QALY) compared to discharge home without a WCD. Discharge to a skilled nursing facility and in-hospital monitoring resulted in higher costs and worse clinical outcomes. The incremental cost-effectiveness ratio was as low as $15,392/QALY if the WCD successfully terminated 95% of SCA events and exceeded the $50,000/QALY willingness-to-pay threshold if the efficacy was69%.The WCD strategy remained cost-effective, assuming 5.6% 2-month SCA risk, as long as the time to reimplantation was at least 2 weeks.The WCD likely is cost-effective in protecting patients against SCA after infected ICD removal while waiting for ICD reimplantation compared to keeping patients in the hospital or discharging them home or to a skilled nursing facility.

This study sought to evaluate the impact of abandoned cardiovascular implantable electronic device (CIED) leads on the presentation and management of device-related infections.Device infection is a serious consequence of CIEDs and necessitates removal of all hardware for attempted cure. The merits of extracting or retaining presumed sterile but nonfunctioning leads is a subject of ongoing debate.The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled patients with CIED infections at 10 institutions in the United States and abroad between January 1, 2009, and December 31, 2012. Within a propensity-matched cohort, relevant clinical information was compared between patients who had 1 or more abandoned leads at the time of infection and those who had none.Matching produced a cohort of 264 patients, including 176 with no abandoned leads and 88 with abandoned leads. The groups were balanced with respect to Charlson comorbidity index, oldest lead age, device type, sex, and race. At the time of admission, those with abandoned leads were less likely to demonstrate systemic signs of infection, including leukocytosis (p = 0.023) and positive blood cultures (p = 0.005). Conversely, patients with abandoned leads were more likely to demonstrate local signs of infections, including skin erosion (p = 0.031) and positive pocket cultures (p = 0.015). In addition, patients with abandoned leads were more likely to require laser extraction (p = 0.010).The results of a large prospective registry of CIED infections demonstrated that patients with abandoned leads may present with different signs, symptoms, and microbiological findings and require laser extraction more than those without abandoned leads.

Background— Infection is a serious complication of cardiovascular-implantable electronic device implantation and necessitates removal of all hardware for optimal treatment. Strategies for reimplanting hardware after infection vary widely and have not previously been analyzed using a large, multicenter study. Methods and Results— The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled subjects with cardiovascular-implantable electronic device infections at multiple institutions in the United States and abroad between 2009 and 2012. Reimplantation strategies were evaluated overall, and every patient who relapsed within 6 months was individually examined for clinical information that could help explain the negative outcome. Overall, 434 patients with cardiovascular-implantable electronic device infections were prospectively enrolled at participating centers. During the initial course of therapy, complete device removal was done in 381 patients (87.8%), and 220 of them (57.7%) were ultimately reimplanted with new devices. Overall, the median time between removal and reimplantation was 10 days, with an interquartile range of 6 to 19 days. Eleven of the 434 patients had another infection within 6 months, but only 4 of them were managed with cardiovascular-implantable electronic device removal and reimplantation during the initial infection. Thus, the repeat infection rate was low (1.8%) in those who were reimplanted. Patients who retained original hardware had a 11.3% repeat infection rate. Conclusions— Our study findings confirm that a broad range of reimplant strategies are used in clinical practice. They suggest that it is safe to reimplant cardiac devices after extraction of previously infected hardware and that the risk of a second infection is low, regardless of reimplant timing.

In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial.Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

Objectives The purpose of this study was to determine whether the clinical presentation of lead-associated endocarditis (LAE) is related to the size of lead vegetations and how size is related to bacteriology and clinical outcomes. Background Cardiac implantable electronic device (CIED) infection may present as either local pocket infection or bloodstream infection with or without LAE. LAE is associated with significant morbidity and mortality. Methods The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the MEDIC registry between January 1, 2009 and December 31, 2012 were analyzed. The clinical features and outcomes of 2 groups of patients were compared based on the size of the lead vegetation detected by echocardiography (> or Results There were 129 patients with LAE enrolled into the MEDIC registry. Of these, 61 patients had a vegetation Conclusions The clinical presentation of LAE is influenced by the size of the lead vegetation. Prompt recognition and management of LAE depends on obtaining blood cultures and echocardiography, including transesophageal echocardiography, in CIED patients who present with either signs of local pocket or systemic infection.

Background A higher frequency Excimer laser sheath using an 80-Hz pulse repetitive rate was approved by the Food and Drug Administration in April 2012. We reported our initial clinical experience with a high-frequency Excimer laser sheath and compared it with lower-frequency laser sheaths which have been previously used. Methods In this single center, retrospective cohort study, we evaluated patients who underwent lead extraction from December 2008 to May 2013. Those who underwent lead removal without using a laser sheath or with approaches other than subclavian were excluded. Primary endpoints included total laser time, number of pulses, and complications. Data on clinical characteristics, lead type, indications, and outcomes were prospectively collected and analyzed. Results A total of 427 patients were included in the study (72.6% male; age 67.9 ± 15.23 years). Lower frequency and higher frequency laser sheaths were used in 315 and 112 patients, respectively. A total of 821 leads were removed with 765 leads (93.2%) extracted using the Excimer laser sheath. Lead age was 5.71 ± 4.96 years. Complete extraction was seen in all patients. A higher-frequency laser sheath was associated with a lower laser time and a lower total number of laser pulses even after adjustments for the number of leads, type of leads, and lead age. In the higher frequency group, mortality rate was 0.9% and minor complication rate was 3.6%. Conclusions When compared with the lower-frequency laser sheath, the higher-frequency laser sheath requires less laser times and more efficient amount of pulses for lead extraction with comparable success rate. Due to the rarity of major and minor complications, no statistical significance was found between the two groups.