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.

Strategies and outcomes of patients with severely reduced ejection fraction (≤15%) undergoing transvenous lead extraction: A single-center experience.

BACKGROUND: Patients with severely reduced ejection fraction (SREF ≤15%) are deferred from transvenous lead extraction (TLE) owing to fear of intraoperative hemodynamic collapse. When these patients require lead extraction, their management options are limited, and they suffer from high morbidity and mortality. Left ventricular (LV) assist devices provide intraoperative hemodynamic support and facilitate TLE, enabling lifesaving interventions. OBJECTIVE: We present our experience of performing TLE in 245 patients with SREF. Additionally, we report outcomes of 8 patients who received LV support during TLE. METHODS: Between January 2008 and January 2022, we performed TLE in 245 patients with stage D heart failure, SREF, and class I or II indications for extraction. Primary (clinical success and in-hospital mortality) and secondary (length of stay and procedure-associated complications) outcomes were compared between patients with SREF and patients in our registry undergoing extraction with EF < 15%. A subgroup analysis was performed in the SREF group to evaluate outcomes of 8 patients who underwent extraction with LV assist devices. RESULTS: In patients with SREF, clinical success was high (97.6%) and mortality was low (5.3%). There were no statistically significant differences in primary outcomes between groups. Similarly, there were no significant differences in procedural complications between groups. In the SREF group, there were no significant differences in outcomes between the 8 patients undergoing TLE with LV assist devices and patients that did use LV assist devices. CONCLUSION: Lead extraction in patients with SREF can be performed safely and effectively. Adopting a few simple steps, including the early initiation of LV support, can overcome myocardial impairment in patients who decompensate.

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.

Location of Superior Vena Cava Tears in Transvenous Lead Extraction.

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.

Endovascular occlusion balloon-related thrombosis during transvenous lead extraction.

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.

A Unique Case of Elizabethkingia Associated Cardiac Device Infection.

Elizabethkingia is a ubiquitous gram-negative aerobic bacillus that has gained attention in recent years as an emerging nosocomial infection in critically ill patients. We describe a case of bacteremia that developed in a patient who underwent complicated surgery with an extended intensive care unit (ICU) stay. The patient underwent pacemaker extraction with laser lead extraction and treatment with intravenous antibiotics. This case illustrates the importance of lead management strategies in septic patients with cardiac implantable electronic devices (CIED).

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.

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.

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%.

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.

Cardiac conduction abnormalities associated with pacemaker implantation after transcatheter aortic valve replacement.

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.

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.