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BACKGROUND: Data on transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving transvenous lead extraction (TLE) followed by angioplasty and stenting. OBJECTIVE: The purpose of this study was to describe the management and outcome of TV lead-associated SVC syndrome. METHODS: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023. RESULTS: Fifteen patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling of the face, neck, and upper extremities (67%); shortness of breath (53%); and lightheadedness (40%). Patients had an average of 2 ± 0.7 leads crossing the SVC, with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with TLE, followed by SVC stenting and angioplasty in 10 and angioplasty alone in 2; 1 patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting, which was managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence, and none of the 5 patients without lead reimplantation had recurrence of symptoms. CONCLUSION: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence.
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BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction. OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months. METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system. RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%. CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.
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AIMS: Cardiac implantable electronic device (CIED) infections are a burden to hospitals and costly for healthcare systems. Chronic kidney disease (CKD) increases the risk of CIED infections, but its differential impact on healthcare utilization, costs, and outcomes is not known. METHODS AND RESULTS: This retrospective analysis used de-identified Medicare Fee-for-Service claims to identify patients implanted with a CIED from July 2016 to December 2020. Outcomes were defined as hospital days and costs within 12 months post-implant, post-infection CKD progression, and mortality. Generalized linear models were used to calculate results by CKD and infection status while controlling for other comorbidities, with differences between cohorts representing the incremental effect associated with CKD. A total of 584 543 patients had a CIED implant, of which 26% had CKD and 1.4% had a device infection. The average total days in hospital for infected patients was 23.5 days with CKD vs. 14.5 days (P < 0.001) without. The average cost of infection was $121 756 with CKD vs. $55 366 without (P < 0.001), leading to an incremental cost associated with CKD of $66 390. Infected patients with CKD were more likely to have septicaemia or severe sepsis than those without CKD (11.0 vs. 4.6%, P < 0.001). After infection, CKD patients were more likely to experience CKD progression (hazard ratio 1.26, P < 0.001) and mortality (hazard ratio 1.89, P < 0.001). CONCLUSION: Cardiac implantable electronic device infection in patients with CKD was associated with more healthcare utilization, higher cost, greater disease progression, and greater mortality compared to patients without CKD.
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Desfibriladores Implantáveis , Progressão da Doença , Marca-Passo Artificial , Infecções Relacionadas à Prótese , Insuficiência Renal Crônica , Humanos , Insuficiência Renal Crônica/terapia , Insuficiência Renal Crônica/economia , Insuficiência Renal Crônica/mortalidade , Masculino , Feminino , Desfibriladores Implantáveis/economia , Desfibriladores Implantáveis/efeitos adversos , Estudos Retrospectivos , Idoso , Estados Unidos/epidemiologia , Infecções Relacionadas à Prótese/economia , Infecções Relacionadas à Prótese/mortalidade , Marca-Passo Artificial/economia , Marca-Passo Artificial/efeitos adversos , Marca-Passo Artificial/estatística & dados numéricos , Idoso de 80 Anos ou mais , Custos de Cuidados de Saúde/estatística & dados numéricos , Medicare/economia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Tempo de Internação/economiaRESUMO
BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.
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BACKGROUND: Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. METHODS: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. RESULTS: Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. CONCLUSION: Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.
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Anticoagulantes , Estimulação Cardíaca Artificial , Heparina , Marca-Passo Artificial , Humanos , Heparina/administração & dosagem , Heparina/efeitos adversos , Masculino , Idoso , Feminino , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Resultado do Tratamento , Estudos Retrospectivos , Fatores de Tempo , Fatores de Risco , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Esquema de Medicação , Implantação de Prótese/instrumentação , Implantação de Prótese/efeitos adversos , Desenho de PróteseRESUMO
BACKGROUND: One common mode of lead failure is insulation breach, which may result in myopotential noise and device malfunction. "Pseudo-unipolarization" of bipolar pacing stimuli, as observed from a routine 12-lead electrocardiogram (ECG) due to stimulus current leak, has been observed with insulation breaches. OBJECTIVE: We sought to characterize this electrocardiographic finding to detect this type of lead malfunction. METHODS: A total of 138 transvenous leads were analyzed, including 88 with known malfunction and 50 normal leads. The amplitude of a bipolar pacing stimulus on the ECG was recorded and compared with a control data set of newly implanted leads with bipolar stimuli normalized for output. RESULTS: The malfunction group consisted of 61% right atrium and 39% right ventricle leads with mean pacing output of 2.74 V at 0.5 ms. There was a significant difference in ECG bipolar stimulus amplitudes at time of identification of failure (7.89 ± 7.56 mm/V; P < .001) compared with those of normal leads (0.86 ± 0.41 mm/V). Receiver operating characteristic curve for the prediction of lead malfunction based on absolute ECG amplitude displayed an area under the curve of 0.93 (95% CI, 0.891-0.969). When normalized for programmed stimulus output, a cutoff of 5 mm/V demonstrated a sensitivity of 91% and a specificity of 92% (area under the curve, 0.967; 95% CI, 0.938-0.996). CONCLUSION: The maximum amplitude of a bipolar pacing stimulus on the ECG is significantly lower in normal functioning leads compared with those with known malfunction. This simply derived variable demonstrated good accuracy at identifying lead failure due to insulation breach.
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BACKGROUND AND AIMS: Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. METHODS: All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. RESULTS: 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR: 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI): 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR: .47, 95% CI: .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI: 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001). CONCLUSIONS: Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.
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Arritmias Cardíacas , Marca-Passo Artificial , Humanos , Arritmias Cardíacas/terapia , Arritmias Cardíacas/etiologia , Resultado do Tratamento , Desenho de Equipamento , Marca-Passo Artificial/efeitos adversos , Sistema de Registros , Estimulação Cardíaca Artificial/efeitos adversosRESUMO
INTRODUCTION: Transvenous leads have been implicated in tricuspid valve (TV) dysfunction, but limited data are available regarding the effect of extracting leads across the TV on valve regurgitation. The aim of this study is to quantify tricuspid regurgitation (TR) before and after lead extraction and identify predictors of worsening TR. METHODS: We studied 321 patients who had echocardiographic data before and after lead extraction. TR was graded on a scale (0 = none/trivial, 1 = mild, 2 = moderate, 3 = severe). A change of >1 grade following extraction was considered significant. RESULTS: A total of 321 patients underwent extraction of a total of 338 leads across the TV (1.05 ± 0.31 leads across the TV per patient). There was no significant difference on average TR grade pre- and postextraction (1.18 ± 0.91 vs. 1.15 ± 0.87; p = 0.79). TR severity increased after extraction in 84 patients, but was classified as significantly worse (i.e., >1 grade change in severity) in only 8 patients (2.5%). Use of laser lead extraction was associated with a higher rate of worsening TR postextraction (44.0% vs. 31.6%, p = 0.04). CONCLUSION: In our single-center analysis, extraction of leads across the TV did not significantly affect the extent of TR in most patients. Laser lead extraction was associated with a higher rate of worsening TR after extraction.
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Remoção de Dispositivo , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/etiologia , Insuficiência da Valva Tricúspide/diagnóstico , Masculino , Feminino , Remoção de Dispositivo/efeitos adversos , Idoso , Resultado do Tratamento , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Valva Tricúspide/fisiopatologia , Valva Tricúspide/cirurgia , Valva Tricúspide/diagnóstico por imagem , Desfibriladores Implantáveis , Fatores de Tempo , Marca-Passo Artificial , Idoso de 80 Anos ou mais , Dispositivos de Terapia de Ressincronização CardíacaRESUMO
PURPOSE OF REVIEW: Tricuspid regurgitation is a commonly encountered valvular pathology in patients with trans-tricuspid pacing or implantable cardioverter-defibrillator leads. Transcatheter tricuspid valve interventions are increasingly performed in patients at high surgical risk. Implantation of these valves can lead to the "jailing" of a trans-tricuspid lead. This practice carries both short- and long-term risks of lead failure and subsequent infection without the ability to perform traditional transvenous lead extraction. Herein, this manuscript reviews available therapeutic options for lead management in patients undergoing transcatheter tricuspid valve interventions. RECENT FINDINGS: The decision to jail a lead may be appropriate in certain high-risk cases, though extraction may be a better option in most cases given the variety of options for re-implant, including leadless pacemakers, valve-sparing systems, epicardial leads, leads placed directly through prosthetic valves, and the completely subcutaneous implantable-defibrillator. A growing number of patients meet the requirement for CIED implantation in the United States. A significant proportion of these patients will have tricuspid valve dysfunction, either related to or independent of their transvenous lead. As with any percutaneous intervention that has shown efficacy, the role of TTVI is also likely to increase as this therapy advances beyond the investigational phase. As such, the role of the heart team in the management of these patients will be increasingly critical in the years to come, and in those patients that have pre-existing CIED leads, we advocate for the involvement of an electrophysiologist in the heart team.
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Desfibriladores Implantáveis , Implante de Prótese de Valva Cardíaca , Marca-Passo Artificial , Insuficiência da Valva Tricúspide , Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/cirurgia , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Cateterismo Cardíaco/métodos , Estimulação Cardíaca Artificial/métodos , Próteses Valvulares Cardíacas , Remoção de Dispositivo/métodosRESUMO
BACKGROUND: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. New-onset post-operative AF may signal an elevated risk of AF and associated outcomes in long-term follow-up. We aimed to estimate the rate of AF recurrence as detected by an implantable loop recorder (ILR) in patients experiencing post-operative AF within 30 days after cardiac surgery. METHODS: We searched MEDLINE, Embase and Cochrane CENTRAL to April 2023 for studies of adults who did not have known AF, experienced new-onset AF within 30 days of cardiac surgery and received an ILR. We pooled individual participant data on timing of AF recurrence using a random-effects model with a frailty model applied to a Cox proportional hazard analysis. RESULTS: From 8671 citations, 8 single-centre prospective cohort studies met eligibility criteria. Data were available from 185 participants in 7 studies, with a median follow-up of 1.7 (IQR: 1.3-2.8) years. All included studies were at a low risk of bias. Pooled AF recurrence rates following 30 post-operative days were 17.8% (95% CI 11.9%-23.2%) at 3 months, 24.4% (17.7%-30.6%) at 6 months, 30.1% (22.8%-36.7%) at 12 months and 35.3% (27.6%-42.2%) at 18 months. CONCLUSIONS: In patients who experience new-onset post-operative AF after cardiac surgery, AF recurrence lasting at least 30 s occurs in approximately 1 in 3 in the first year after surgery. The optimal frequency and modality to use for monitoring for AF recurrence in this population remain uncertain.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Eletrocardiografia Ambulatorial , Complicações Pós-Operatórias , Recidiva , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/etiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Eletrocardiografia Ambulatorial/instrumentaçãoRESUMO
BACKGROUND: Leadless pacemakers (LPs) capable of VDD pacing allow for atrioventricular synchrony through mechanical sensing of atrial contraction. However, mechanical sensing is less reliable and less predictable than electrical sensing. OBJECTIVE: The purpose of this study was to evaluate P-wave amplitude during sinus rhythm from preoperative 12-lead electrocardiograms (ECGs) as a predictor for atrial mechanical sensing in patients undergoing VDD LP implantation. METHODS: Consecutive patients undergoing VDD LP implantation were included in this 2-center prospective cohort study. ECG parameters were evaluated separately and in combination for association with the signal amplitude of atrial mechanical contraction (A4). RESULTS: Eighty patients (median age 82 years; female 55%; mean body mass index [BMI] 25.8 kg/m2) were included in the study and 61 patients in the A4 signal analysis (19 patients in VVI mode during follow-up). Absolute (aVL, aVF, V1, V2) and BMI-adjusted (I, II, aVL, aVF, aVR, V1, V2) P-wave amplitudes from baseline ECGs demonstrated a statistically significant positive correlation with A4 signal amplitude (all P <.05). A combined P-wave signal amplitude of at least 0.2 mV in V1 and aVL was predictive, with specificity of 83% (95% confidence interval 67%-100%) for A4 signal ≥1 m/s2. We found a significant correlation of A4 signal amplitude and overall atrioventricular synchrony (P = .013). CONCLUSION: P-wave amplitudes in ECG leads aVL and V1 can predict A4 signal amplitude in patients with VDD LP and therefore the probability of successful AV synchronous pacing.
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Estimulação Cardíaca Artificial , Eletrocardiografia , Átrios do Coração , Marca-Passo Artificial , Humanos , Feminino , Masculino , Idoso de 80 Anos ou mais , Estudos Prospectivos , Estimulação Cardíaca Artificial/métodos , Átrios do Coração/fisiopatologia , Idoso , Desenho de Equipamento , SeguimentosRESUMO
BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.