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1.
Circ Arrhythm Electrophysiol ; 13(7): e008168, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32538135

RESUMO

BACKGROUND: Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation. METHODS: An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed. RESULTS: The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P=0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P=0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P=0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P=0.006). The C statistic was 0.78. CONCLUSIONS: In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.

2.
Heart Rhythm ; 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32512177

RESUMO

BACKGROUND: Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures. OBJECTIVE: The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures. METHODS: All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined. RESULTS: Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P <.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates. CONCLUSION: Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates.

3.
Heart Rhythm ; 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32438016

RESUMO

BACKGROUND: Virtual visits (VVs) are a modality for delivering health care services remotely through videoconferencing tools. Data about patient and physician experience in using VVs are limited. OBJECTIVE: The purpose of this study was to assess patient and physician experience with the use of VVs in cardiac electrophysiology. METHODS: We performed a prospective survey of cardiac electrophysiology patients and physicians who participated in an outpatient VV from December 2018 to July 2019. RESULTS: One-hundred consecutive VVs were included. Sixty-four patients elected to complete a survey. Patients rated their experience as either excellent/very good in scheduling a VV (87%), seeing their physician of choice (100%), transmitting arrhythmia data (88%), rating their physician's ability to communicate (98%), asking all questions (98%), rating the level of care received (98%), paying for the cost of a VV (67%), and rating their overall level of satisfaction (98%). Thirty-eight of 64 patients (59.4%) preferred a VV for their next visit, 12 of 64 (18.8%) preferred an in-office visit, 13 of 64 (20.3%) responded that their decision for a virtual or office visit depended on indication, and 1 of 64 (1.6%) had no preference. A total of 14 cardiac electrophysiologists participated in 100 VVs. Nine visits were not included due to technical difficulty. Physician responses to survey questions were rated as excellent/very good in the ability to communicate (92%), accessing monitoring data (95%), and overall level of satisfaction (98%). CONCLUSION: In our small study population, most patients and physicians prefer VVs. Convenience, cost, and reason for follow-up were important determinants that affected both patient and physician preference.

4.
Artigo em Inglês | MEDLINE | ID: mdl-32452039

RESUMO

BACKGROUND: Programmed long AV delays and intrinsic long first degree AV block may increase risk for competitive atrial pacing (CAP) in devices without CAP avoidance algorithms. METHODS: Patients identified with CAP-induced mode switch episodes were followed clinically from September 2013 to August 2019. Attempts to avoid CAP included shortening of postventricular atrial refractory period (PVARP) or postventricular atrial blanking period (PVAB), or change to AAI or DDI modes. After observing associations with sensor-driven pacing, rate response was inactivated in a subset. RESULTS: Among 23 patients identified with CAP (22 St Jude Medical [Abbott]; one Boston Scientific Corporation devices), atrial fibrillation (AF) was induced in 12 (52%), lasting 10 seconds to 28 hours and 32 minutes. In one patient with an ICD CAP-induced AF with rapid ventricular rates that triggered a shock, inducing ventricular fibrillation, syncope, and another shock. Changing AV delays and shortening of PVARP failed to resolve CAP. After noting that all had CAP during sensor-driven pacing, rate response was inactivated in seven, resolving further device-induced AF in the three of seven that had prior CAP-induced AF. In two patients with intact AV conduction, AAI(R) pacing resolved further documentation of CAP. CONCLUSIONS: CAP predominantly occurs during sensor-driven atrial pacing that competes with intrinsic atrial events falling in PVARP. Inactivation of the activity sensor or change to atrial-based pacing modes (AAI/R) appears to effectively prevent induction of device-induced atrial proarrhythmia. Ultimately, a corrective algorithm is needed to avoid CAP-induced proarrhythmia.

5.
Circ Arrhythm Electrophysiol ; 13(5): e008280, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32281393

RESUMO

BACKGROUND: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. METHODS: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. RESULTS: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage. CONCLUSIONS: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

6.
Heart Rhythm ; 17(8): 1298-1303, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32205298

RESUMO

BACKGROUND: Injury to the cardiac venous structures can complicate left ventricular lead placement for cardiac resynchronization therapy (CRT). Little is known about the outcomes of coronary sinus (CS) dissection with or without perforation. OBJECTIVE: The purpose of this study was to determine the outcomes in patients who had a CS injury during CRT implantation. METHODS: All patients undergoing procedures for CRT implantation at the Cleveland Clinic (2001-2018) were enrolled in a prospectively maintained registry for procedural profiles and complications. All patients with cardiac venous injuries during the procedures were included. RESULTS: CS injury occurred in 35 of 5011 patients (0.7%; 6 perforations (17.1%), 29 dissections without perforation (82.9%)). In patients with dissection in the absence of perforation, attempts at CS lead placement after dissection were successful in 21 of 29 patients (72.4%). In those with perforation (n=6, 17.1%), CS lead placement was successful in one of them (16.7%). Cardiac tamponade occurred in 2 patients (5.7%), and the procedure was aborted in both of them. Overall, CS lead placement failed in 13 patients (37%) but 9 (25.7%) underwent subsequent CRT with CS lead placement (n=6, 17.1%; median 58 days later) or epicardial leads (n=3, 8.6%). Three of the remaining 4 patients (8.6%) refused to undergo further procedures, and the fourth (2.9%) died of a complicated course. CONCLUSION: CS injury is not common during CRT implantation procedures and did not preclude successful lead placement in 23 of 35 patients (65.7%) during the index procedure and 6 of 6 (100%) during the subsequent attempted procedures. A low rate of mortality was observed in such patients, but CS injury was associated with increased morbidity.

7.
Heart Rhythm ; 17(7): 1115-1122, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32087357

RESUMO

BACKGROUND: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN). OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications. METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling. RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics). CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.

8.
J Cardiovasc Electrophysiol ; 31(5): 1182-1186, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32108406

RESUMO

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in patients with medically refractory heart failure and wide QRS duration. While much is known about predictors of left ventricular (LV) remodeling after CRT implantation and short-term mortality, limited data exist on long-term outcomes after CRT placement. METHODS: We retrospectively reviewed all patients undergoing CRT implantation at our center between 2003 and 2008 and examined mortality using institutional electronic records, social security death index, and online obituary search. We included only patients with preimplant echoes with LV ejection fraction (LVEF) 35% or below. Variable selection was performed using stepwise regression and models were compared using goodness-of-fit criteria. A final model was validated with the bootstrap regression method. RESULTS: Out of the 877 CRT patients undergoing implantation during this time, 287 (32.7%) survived longer than 10 years. Significant (P < .05) predictors of survival in our multivariate model were age, left ventricular diastolic diameter, sex, presence of nonischemic vs ischemic cardiomyopathy, QRS duration, atrial fibrillation, BNP levels, and creatinine levels at the time of CRT implantation. A model using the odds ratios from these variables had a receiver operating curve with an area under the curve score of 0.816 (standard error, 0.019) at predicting survival or freedom from LVAD or heart transplant for longer than 10 years after CRT implantation. The specificity for factors 3 or above and 5 or above was 68% and 77%, respectively. CONCLUSION: A large proportion of patients are still alive 10 years after CRT implantation. Variables at the time of CRT implant can help provide prognostic information to patients and electrophysiologists to determine the long-term benefit and survival of patients after CRT implantation.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31960345

RESUMO

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.

10.
Heart Rhythm ; 17(1): e220-e228, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31103461

RESUMO

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.

11.
Catheter Cardiovasc Interv ; 95(5): 1042-1048, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-31429191

RESUMO

OBJECTIVES: To develop a protocol for using a pre-existing, permanent pacemaker or defibrillator device for rapid ventricular pacing during transcatheter valve procedures and demonstrate feasibility. BACKGROUND: Placement of a passive fixation, temporary pacemaker wire is considered routine during most transcatheter valve procedures to facilitate controlled or rapid ventricular pacing at the time of balloon expansion or valve deployment. Many patients presenting for such procedures have a pre-existing, permanent pacemaker or defibrillator device which could be used for the same function, obviating the need for temporary pacemaker wire placement. METHODS: We developed a strategy for rapid pacing from the pre-existing device using a programmer during transcatheter valve procedures in consecutive patients over a 3-month period. Complications and clinical outcomes were recorded. RESULTS: There were 135 transcatheter valve procedures performed during the study. Of these, 28 (20.7%) had pre-existing devices (17 transcatheter aortic valve replacement, 3 aortic valve-in-valve, 2 mitral valve-in-valve, and 6 balloon aortic valvuloplasty). All patients underwent rapid ventricular pacing using a commercially available device programmer. There were no adverse events related to device pacing and no patients required placement of a temporary pacemaker wire during the procedure. At 30-days follow-up, there were no deaths, one major vascular complication related to arterial access, and one patient with renal failure requiring dialysis. CONCLUSION: Pacing from a commercially available device programmer is safe, feasible, and may reduce both procedural cost and complications such as cardiac tamponade by avoiding placement of a temporary pacemaker lead during transcatheter valve procedures.

13.
Pacing Clin Electrophysiol ; 43(1): 118-122, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31782195

RESUMO

BACKGROUND: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important. METHODS: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED. RESULTS: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%). CONCLUSION: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs.

14.
J Interv Card Electrophysiol ; 58(1): 103-111, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31875270

RESUMO

BACKGROUND: Heart Rate Score (HrSc), a novel index found to predict mortality in patients with implantable defibrillator (ICD) and cardiac resynchronization defibrillator (CRT-D) devices, is associated with mortality in ICD and CRT-D recipients when HrSc is ≥ 70%. Implantable defibrillator shocks have also been associated with increased mortality in ICD and CRT-D recipients. The objective of this study was to evaluate the relationships between HrSc, shocks, and mortality in ICD and CRT-D patients. METHODS: HrSc was calculated from atrial sensed and paced rate histograms collected from the 2006-2011 ALTITUDE remote interrogation database. Shocks were determined in the first year of follow-up. Mortality was assessed over the next 4 years by the Social Security Death Index. Four multivariable models were run: ICD and CRT-D, shock and no shock, with mortality as the outcome and HrS as predictor. RESULTS: Data from 49,358 ICD and 55,953 CRT-D patients were divided into HrSc: ≥ 70%, 30-69%, and < 30%. Shock rates differed between HrSc groups (p < 0.001) for ICD and CRT-D patients. However, the lowest mortality risk HrSc (< 30%) had the highest shock rate. Both highest HrSc (> 70%; p < 0.001) and shocks (p < 0.001) predicted mortality during follow-up. Mortality was unrelated to interactions between HrSc and shocks in ICD patients (p = 0.275) or CRT-D patients (p < 0.079). Comparing HrSc ≥ 70% to HrSc < 30%, HrSc ≥ 70% predicted mortality in CRT-D (HR 1.40; 95% CI 1.29-1.52) and ICD (HR 1.23; 95% CI 1.11-1.36) patients regardless of shocks (P < 0.001 for both). CONCLUSIONS: Patients with ICDs or CRT-Ds having the lowest mortality risk HrSc had the highest shock rate. Shocks and HrSc appear to complement each other as predictors of mortality.

16.
JACC Clin Electrophysiol ; 5(12): 1432-1438, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31857043

RESUMO

OBJECTIVES: This study sought to retrospectively investigate outcomes of lead extraction by using pre-operative computed tomography (CT) scans to identify risk of complicated lead extraction to aid in pre-procedural planning. BACKGROUND: Transvenous lead extractions remain high-risk procedures requiring specialized operators, equipment, and surgical backup. Data are lacking for how to identify difficult lead extractions. CT scans, which can illustrate the proximity of the lead to adherent venous structures can potentially aid in identifying difficult lead extractions. METHODS: All cases of patients who were undergoing transvenous lead extractions at the authors' institution between 2015 and 2018, who had a pre-operative CT scan prior to lead extraction, were reviewed. The images were retrospectively reviewed to examine adherence of leads to the surrounding vein and obtained procedural outcomes. RESULTS: A total of 203 cases were reviewed of patients undergoing transvenous lead extraction who had a pre-operative CT scan, and scans were separated based on lead location in the superior vena cava, as assessed by CT imaging. Scans were divided into 3 groups: those in a central location or <1 cm adherence (n = 28); those that had at least 1 lead with tip adherent >1 cm (n = 137); or those that had at least 1 lead outside the vein contour (n = 38). Although there was only 1 serious complication requiring vascular surgery intervention, patients with at least 1 lead outside the vein contour required significantly longer procedural time (190.8 ± 86.6 min vs. 158.1 ± 73.7 min vs. 142.8 ± 52.2 min; p = 0.019) and fluoroscopy time (33.1 ± 24.2 min vs. 19.6 ± 18.4 min vs. 18.3 ± 16.4 min; p = 0.0006) than those with leads adhering >1 cm and centrally located leads, respectively. CONCLUSIONS: Pre-operative CT scanning can identify difficult lead extractions prior to performing the procedure. This information may aid electrophysiologists in the planning of extraction procedures. Future prospective studies are needed to confirm these findings.

19.
Circ Arrhythm Electrophysiol ; 12(8): e007266, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31401856

RESUMO

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.


Assuntos
Oclusão com Balão/métodos , Remoção de Dispositivo/efeitos adversos , Eletrodos Implantados/efeitos adversos , Procedimentos Endovasculares/métodos , Complicações Intraoperatórias , Lesões do Sistema Vascular/cirurgia , Veia Cava Superior/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Flebografia , Estudos Retrospectivos , Resultado do Tratamento , Lesões do Sistema Vascular/diagnóstico , Lesões do Sistema Vascular/etiologia , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/lesões
20.
J Arrhythm ; 35(3): 485-493, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31293697

RESUMO

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter-defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer-specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life-threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision-making process.

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