Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection.

Importance: Complete hardware removal is a class I recommendation for cardiovascular implantable electronic device (CIED) infection, but practice patterns and outcomes remain unknown. Objective: To quantify the number of Medicare patients with CIED infections who underwent implantation from 2006 to 2019 and lead extraction from 2007 to 2019 to analyze the outcomes in these patients in a nationwide clinical practice cohort. Design, Setting, and Participants: This cohort study included fee-for-service Medicare Part D beneficiaries from January 1, 2006, to December 31, 2019, who had a de novo CIED implantation and a CIED infection more than 1 year after implantation. Data were analyzed from January 1, 2005, to December 31, 2019. Exposure: A CIED infection, defined as (1) endocarditis or infection of a device implant and (2) documented antibiotic therapy. Main Outcomes and Measures: The primary outcomes of interest were device infection, device extraction, and all-cause mortality. Time-varying multivariable Cox proportional hazards regression models were used to evaluate the association between extraction and survival. Results: Among 1 065 549 patients (median age, 78.0 years [IQR, 72.0-84.0 years]; 50.9% male), mean (SD) follow-up was 4.6 (2.9) years after implantation. There were 11 304 patients (1.1%) with CIED infection (median age, 75.0 years [IQR, 67.0-82.0 years]); 60.1% were male, and 7724 (68.3%) had diabetes. A total of 2102 patients with CIED infection (18.6%) underwent extraction within 30 days of diagnosis. Infection occurred a mean (SD) of 3.7 (2.4) years after implantation, and 1-year survival was 68.3%. There was evidence of highly selective treatment, as most patients did not have extraction within 30 days of diagnosed infection (9202 [81.4%]), while 1511 (13.4%) had extraction within 6 days of diagnosis and 591 (5.2%) had extraction between days 7 and 30. Any extraction was associated with lower mortality compared with no extraction (adjusted hazard ratio [AHR], 0.82; 95% CI, 0.74-0.90; P < .001). Extraction within 6 days was associated with even lower risk of mortality (AHR, 0.69; 95% CI, 0.61-0.78; P < .001). Conclusions and Relevance: In this study, a minority of patients with CIED infection underwent extraction. Extraction was associated with a lower risk of death compared with no extraction. The findings suggest a need to improve adherence to guideline-directed care among patients with CIED infection.

Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: a 'heart team' approach.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of 'jailing' a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this 'state-of-the-art' review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the 'heart team' when making treatment decisions in patients TR and CIED leads.

Endovascular approach to a complex thrombus in-transit through a patent foramen ovale.

Large atrial thrombi can be managed percutaneously. We present a case of a 76-year-old female patient who presented to our emergency room with an acute stroke and was managed with mechanical thrombectomy. Further work-up revealed a large complex thrombus in-transit trapped in a patent foramen ovale with a large mobile portion in the left atrium. Due to contraindications for thrombolysis and poor surgical candidacy, an endovascular approach was favored. The procedure was performed successfully, and the patient recovered uneventfully. Learning objective: Endovascular approach with mechanical thrombectomy can be a treatment option for patients that present with large thrombus in-transit when other therapies are contraindicated.

Acute Presentation of a High-Grade Myxofibrosarcoma Originating in the Thoracic Wall: A Case Report.

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.

Lead-related superior vena cava syndrome: Management and outcomes.

BACKGROUND: Superior vena cava (SVC) syndrome includes the clinical sequalae of facial and bilateral upper extremity edema, dizziness, and occasional syncope. Historically, most cases have been associated with malignancy and treatment is palliative. However, cardiac device leads have been identified as important nonmalignant causes of this syndrome. There are little data on the effectiveness of venoplasty and lead extraction in the management of these patients. OBJECTIVE: The objective of this study was to report the findings associated with the use of balloon angioplasty and lead extraction in the management of 17 patients with lead induced SVC syndrome. METHODS: Data collected from January 2003 to July 2019 identified 17 cases of SVC syndrome at our tertiary center. Their outcomes were compared to a control group of patients without SVC syndrome. A P value of <.05 was considered statistically significant. RESULTS: Of the 17 patients, 13 (76%) underwent transvenous lead extraction and venoplasty. Three patients (18%) were treated with venoplasty alone, and 1 patient (6%) underwent surgical SVC reconstruction. In 10 patients (59%), transvenous reimplantation was necessary. Symptom resolution was achieved in all 17 patients and confirmed at both 6 and 12 months' follow-up. There was no significant difference in the rate of complications associated with transvenous lead extraction for SVC syndrome vs control. CONCLUSION: In patients with SVC syndrome, venoplasty and lead extraction are safe and effective for resolution of symptoms and maintaining SVC patency.

Influence of vegetation shape on outcomes in transvenous lead extractions: Does shape matter?

BACKGROUND: 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. OBJECTIVE: The purpose of this study was to report our experience in the outcomes associated with the percutaneous management of large vegetations. METHODS: 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 was <30% between dimensions; and (2) nonglobular if the difference was >30%. The Fisher exact test and Pearson t test were used for analysis. P <.05 was considered significant. RESULTS: 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). CONCLUSION: 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.

Effect of Prior Sternotomy on Outcomes in Transvenous Lead Extraction.

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.

Symptomatic Aortic Valve Mass - Cardiac Work-Up Challenges and Role of Computed Tomography Angiography: A Case Report.

Cardiac papillary fibroelastoma are rare, benign cardiac tumors that may lead to lethal complications from embolization or valvular dysfunction if left untreated. When working up symptomatic tumors with concomitant angina, traditional diagnostic studies such as cardiac catheterization may predispose the patient to embolic complications if the mass is located in the path of the catheter. Newer, non-invasive diagnostic testing, such as cardiac magnetic resonance imaging or dynamic computed tomography angiography, may be considered in lieu of invasive approaches to avoid potentially devastating complications. We herein present a case report of a 77-year-old female with a symptomatic aortic valve tumor and describe our diagnostic strategy and management.

Cardiovascular implantable electronic device infections due to enterococcal species: Clinical features, management, and outcomes.

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%.

Endovascular Occlusion Balloon for Treatment of Superior Vena Cava Tears During Transvenous Lead Extraction: A Multiyear Analysis and an Update to Best Practice Protocol.

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<0.001). 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.

Symptomatic aortic valve mass - cardiac work-up challenges and role of computed tomography angiography: a case report

Abstract Cardiac papillary fibroelastoma are rare, benign cardiac tumors that may lead to lethal complications from embolization or valvular dysfunction if left untreated. When working up symptomatic tumors with concomitant angina, traditional diagnostic studies such as cardiac catheterization may predispose the patient to embolic complications if the mass is located in the path of the catheter. Newer, non-invasive diagnostic testing, such as cardiac magnetic resonance imaging or dynamic computed tomography angiography, may be considered in lieu of invasive approaches to avoid potentially devastating complications. We herein present a case report of a 77-year-old female with a symptomatic aortic valve tumor and describe our diagnostic strategy and management.

Hybrid off-pump coronary artery bypass grafting surgery and transaortic transcatheter aortic valve replacement: Literature review of a feasible bailout for patients with complex coronary anatomy and poor femoral access.

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.

Minimally Invasive Techniques to Avoid Sternotomy in Complex Lead Extraction Cases.

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.

Racial and ethnic healthcare disparities in patients undergoing laser lead extraction.

BACKGROUND: 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. METHODS: 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. RESULTS: Minority patients were: younger (67.9 ±â€¯14.5 years vs 72.4 ±â€¯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 ±â€¯9.9 days versus 17.4 ±â€¯13.4 days, p < 0.001). There was no significant difference between the proportion of types of infection in both groups. CONCLUSION: Minority patients with CIEDIs experienced more procedural complications during extraction and had a significantly longer length of index hospitalization than Caucasian patients.

Cardiac and Vascular Injuries Sustained During Transvenous Lead Extraction.

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.

Surgical and Hybrid Lead Extraction.

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.

Transvenous Lead Extractions: Current Approaches and Future Trends.

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.

Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

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 < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques. CONCLUSION: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques.

Impact of Abandoned Leads on Cardiovascular Implantable Electronic Device Infections: A Propensity Matched Analysis of MEDIC (Multicenter Electrophysiologic Device Infection Cohort).

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.