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1.
J Cardiovasc Electrophysiol ; 31(5): 1147-1154, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32162757

RESUMO

INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.

2.
Artigo em Inglês | MEDLINE | ID: mdl-32048116

RESUMO

PURPOSE: Current guidelines recommend complete extraction of cardiovascular implantable electronic devices (CIEDs) in the case of persistent or recurrent fungemia without other identifiable sources, though supporting evidence is lacking. We sought to evaluate the prognosis of patients with candidemia and CIEDs. METHODS: Twelve consecutive patients (54 ± 12 years, 8 male) with CIED and concurrent candidemia were reviewed. RESULTS: At the time of diagnosis with candidemia, seven patients were immunocompromised, six were on long-term antibacterial therapy, two were intravenous drug users, four were on chronic hemodialysis, and six had a central venous catheter. Four patients were confirmed as definite CIED infection as vegetation was visible on lead by echocardiogram. The other 8 patients were considered possible CIED infection with candidemia of unknown focus. All patients with visible vegetation underwent CIED removal without complications, and other patients were initially managed non-operatively. After 1 year of follow-up, 7 patients had died and at extended follow-up, all patients without lead removal died while 3 of 4 patients with lead extraction survived. Of note, 50% of deaths in the patients without lead removal were associated with fungal sepsis. CONCLUSIONS: Candida fungemia is associated with a high mortality. CIED removal should be an early consideration in these patients even if lead vegetations are not seen.

3.
J Cardiovasc Electrophysiol ; 31(3): 718-722, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32003095

RESUMO

INTRODUCTION: The optimal approach to the extraction of leads with large vegetations remains uncertain. METHODS: High-risk patients with lead associated vegetations undergoing device extraction at Vanderbilt Hospital with concomitant use of the Penumbra Aspiration System (Penumbra Inc, Alameda, CA) are described. An 8.5 Fr Agilis NXT (Abbott Inc, St. Paul, MN) was advanced to the right atrium, through which a Penumbra Indigo Cat-8 catheter was advanced. Using intracardiac echocardiography, the Penumbra was positioned directly on the vegetation, suction was applied until adherent, and the Indigo catheter and Agilis sheath were then removed en-bloc and aspirated debris flushed out. This was repeated until debulking was considered successful. RESULTS: Eight cases were performed. The median vegetation size was 2 cm. Pathogens were Enterococcus, Staphylococcus, Candida, Cutibacterium, and Enterobacter. In seven of eight cases, aspiration successfully reduced vegetations to less than 1 cm before successful percutaneous cardiac implantable electronic device removal. One patient underwent surgical removal via thoracotomy. There were no acute complications related to the Penumbra catheter. Three patients had CT evidence of small pulmonary emboli postprocedure. The length of stay was 3 to 27 days. One patient died on POD 1 of refractory ventricular tachycardia unrelated to the procedure. One patient died of ongoing sepsis 2 weeks postextraction. CONCLUSIONS: The Penumbra Indigo Aspiration system can be useful for vegetation debulking before transvenous lead extraction.

4.
Europace ; 21(11): 1686-1693, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31681964

RESUMO

AIMS: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial. METHODS AND RESULTS: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59). CONCLUSION: Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF.

6.
Heart Rhythm ; 16(12): 1855-1861, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31125674

RESUMO

BACKGROUND: A high rate of malfunction, predominantly intermittent high-frequency artifacts (HFAs), has been recently reported in Abbott Medical Tendril pacing leads. OBJECTIVE: To investigate the factors associated with the occurrence of HFAs on Tendril leads using a commonly used comparator lead for a control. METHODS: We reviewed institutional data for Medtronic CapSureFix 5076 and Abbott Medical Tendril pace-sense leads retrospectively. Recordings deemed to be due to electromagnetic interference and far-field oversensing were not included in the classification of HFAs. RESULTS: A total of 7673 leads were analyzed: 1628 Optim-insulated Tendril leads, 825 non-Optim Tendril leads, and 5220 CapSureFix 5076. HFAs were seen in 212 leads and were more frequently observed in Tendril compared to CapSureFix leads during a mean follow-up of 4.1 ± 3.6 years. Lower age at implant, defibrillator systems, atrial position, and connection to an Abbott Medical generator were associated with increased HFA. In multivariable analysis, only connection to Abbott Medical generators (odds ratio 7.686, P < .001) and age (odds ratio 0.988 per year, P = .016) were independently associated with HFAs on pace-sense leads. In an Abbott-generator-only analysis, Optim-insulated Tendril leads were more likely to display HFAs than non-Optim Tendril leads but not Medtronic CapSureFix 5076 leads. CONCLUSION: Abbott Medical pulse generators independently predict HFA in Tendril and CapSureFix 5076 leads, likely the result of displaying short or low-amplitude noise episodes that other devices do not record. When restricted to Abbott generators only, Optim-insulated Tendril leads show an increased incidence of HFAs when compared to non-Optim Tendril leads but not CapSureFix 5076 leads.

7.
Pacing Clin Electrophysiol ; 42(7): 965-969, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31045260

RESUMO

BACKGROUND: Boston Scientific (Marlborough, MA, USA) implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between 2008 and 2014 are potentially subject to premature battery depletion through a low-voltage capacitor malfunction occurring as a result of hydrogen buildup within the device. Although some of these devices are currently under advisory, other devices manufactured during this timeframe carry a lower risk of the same malfunction. These same devices are known to have superior longevity in general, and the overall mean lifespan of the devices remains long. METHODS: All patients implanted or followed at our two centers who experienced premature battery depletion and had a Boston Scientific ICD or CRT-D potentially at risk for low-voltage capacitor malfunction were studied retrospectively. RESULTS: Nineteen out of 838 patients (2.3%) with devices potentially at risk have had premature battery depletion: 5.7% of those under advisory and 1.1% of those not under advisory. None of our patients had compromised therapy, and all had >27 days of projected battery longevity remaining. CONCLUSIONS: Undetected premature battery depletion in this population of ICDs has the potential to expose a patient to an interval of time where the device is unable to provide therapy. However, with enrollment in remote monitoring, regular follow-up, and attention to audible alerts, the risk of therapy loss due to low-voltage state can be effectively mitigated. For these reasons, prophylactic generator replacement is not recommended.

8.
Pacing Clin Electrophysiol ; 42(7): 970-979, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30977146

RESUMO

BACKGROUND: Reactive atrial-based antitachycardia pacing (rATP) aims to terminate atrial tachyarrhythmia/atrial fibrillation (AT/AF) episodes when they spontaneously organize to atrial flutter or atrial tachycardia; however, its effectiveness in the real-world has not been studied. We used a large device database (Medtronic CareLink, Medtronic, Minneapolis, MN, USA) to evaluate the effects of rATP at reducing AT/AF. METHODS: Pacemaker, defibrillator, and resynchronization device transmission data were analyzed. Eligible patients had device detected AT/AF during a baseline period but were not in persistent AT/AF immediately preceding first transmission. Note that 1:1 individual matching between groups was conducted using age, sex, device type, pacing mode, AT/AF, and percent ventricular pacing at baseline. Risks of AT/AF events were compared between patients with rATP-enabled versus control patients with rATP-disabled or not available in the device. For matched patients, AT/AF event rates at 2 years were estimated by Kaplan-Meier method, and hazard ratios (HRs) were calculated by Cox proportional hazard models. RESULTS: Of 43,440 qualifying patients, 4,203 had rATP on. Matching resulted in 4,016 pairs, totaling 8,032 patients for analysis. The rATP group experienced significantly lower risks of AT/AF events lasting ≥1 day (HR 0.81), ≥7 days (HR 0.64), and ≥30 days (HR 0.56) compared to control (P < 0.0001 for all). In subgroup analysis, rATP was associated with reduced risks of AT/AF events across age, sex, device type, baseline AT/AF, and preventive atrial pacing. CONCLUSIONS: Among real-world patients from a large device database, rATP therapy was significantly associated with a reduced risk of AT/AF. This association was independent of whether the patient had a pacemaker, defibrillator, or resynchronization device.

9.
Case Rep Cardiol ; 2019: 6270950, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30719356

RESUMO

There is an increasing prevalence of cardiac implantable electronic devices (CIEDs) due to expanding adoption and availability of these evidence-based therapies. With the increased prevalence of these life-saving devices, there has also been an increased demand for lead removal and lead extraction. Understanding the specific subgroups of patients at high risk for complications during and after lead extraction has become imperative to properly manage endovascular CIED leads. There have been multiple published studies describing clinical variables that predict adverse outcomes in CIED system extractions; however, the risk of complications in leads placed after cardiac transplantation has not specifically been addressed to date. We present four cases of transvenous extraction and removal of pacing leads placed after cardiac transplantation. There were no major complications related to extraction in these four cases; however, three of the four patients died within one year after the procedure. While the etiology of death in these cases seemed to be unrelated to the extraction procedure, the indications for extraction (infection in the setting of immunosuppression and calcineurin-associated ESRD and poor sensing/capture possibly secondary to chronic rejection and/or frequent right heart biopsies) likely contributed at least indirectly to the subsequent death.

10.
Heart Rhythm ; 16(7): 1131-1132, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30690079
11.
Pharmacotherapy ; 39(1): 94-108, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30548542

RESUMO

As overall prevalence of atrial fibrillation (AF) continues to rise, the number of patients who undergo ablation, or electrical/chemical cardioversion, to restore normal sinus rhythm continues to increase as well. As direct oral anticoagulants (DOACs) have continued to be incorporated into clinical practice for long-term anticoagulation for AF, experience with how best to manage use of DOACs during electrophysiologic procedures is evolving. This review is intended to provide health care providers with a summary of current evidence regarding the use of DOACs during cardioversion and catheter ablation and provide key considerations for their use during such electrophysiologic procedures. PubMed and MEDLINE were searched from inception through June 2018 for studies in humans comparing DOACs alone or against vitamin K antagonists (VKAs) in adult patients (> 18 yrs) who underwent cardioversion or AF catheter ablation using the following key words: "rivaroxaban," "dabigatran," "apixaban," "edoxaban," "non-vitamin K antagonists," "direct or new oral anticoagulants," "warfarin," "vitamin K antagonists," "cardioversion," "ablation of atrial fibrillation," "uninterrupted," and "catheter ablation." Four retrospective studies and three prospective trials comparing DOACs with VKA in patients undergoing cardioversion and three prospective studies in patients undergoing catheter ablation for AF were identified. Observational data and meta-analyses were also critically reviewed. Prospective trials to date suggest similar efficacy and safety with using DOACs in the setting of cardioversion and AF ablation compared to traditional therapy with VKA, with or without bridging. Injectable anticoagulant overlap can be avoided in patients receiving DOACs in the setting of cardioversion for AF. Minimal interruption in anticoagulation may be only necessary for AF ablation in those with highest bleeding risk, such as in renal dysfunction and where drug-drug interactions may increase risk for anticoagulant accumulation. Periprocedural advantages of DOACs include convenience, rapid and predictable onset of effect, improved patient satisfaction, and potential for reduced costs.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/terapia , Vitamina K/antagonistas & inibidores , Administração Oral , Adulto , Anticoagulantes/efeitos adversos , Ablação por Cateter/métodos , Cardioversão Elétrica/métodos , Humanos
15.
Artigo em Inglês | MEDLINE | ID: mdl-29808920

RESUMO

BACKGROUND: Steroid-eluting (SE) electrodes suppress local inflammation and lower pacing capture thresholds (PCT); however, their effectiveness on quadripolar left ventricular (LV) leads in the cardiac vein is not fully studied. We evaluated the effectiveness of SE on all four LV pacing electrodes in human subjects enrolled in the Medtronic Attain® Performa™ quadripolar LV lead study. METHODS: A total of 1,097 subjects were included in this evaluation. At each follow-up visit (1, 3, 6, and 12 months), LV PCT and pacing impedance were measured using either manual or automated testing methods. Summary statistics for PCT and impedance values were obtained for implant and each scheduled follow-up visit for all lead models. RESULTS: Average extended bipolar (LV electrode to right ventricular Coil) PCTs for the four LV SE pacing electrodes (LV1, LV2, LV3, and LV4) on the three shapes of the quadripolar LV leads were 1.06 ± 0.97 V, 1.38 ± 1.26 V, 1.51 ± 1.33 V, and 2.25 ± 1.63 V, respectively, at 0.5-ms pulse width. PCTs remained low and stable throughout the 12-month follow-up period. CONCLUSION: This clinical trial demonstrated that SE on all LV pacing electrodes is associated with low and stable PCTs for all quadripolar LV lead electrodes, resulting in multiple viable vectors for LV pacing. The large number of available vectors facilitates basal pacing, avoidance of PNS, and potentially prolongs generator longevity due to lower PCTs.

16.
Cardiol Rev ; 26(5): 245-254, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29621010

RESUMO

As direct oral anticoagulants (DOACs) have demonstrated favorable efficacy and safety outcomes compared with vitamin K antagonists for the treatment and prevention of venous thromboembolism and the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, their role in the management of anticoagulation during electrophysiological procedures continues to evolve. At present, guidelines are limited regarding specific recommendations for the use of DOACs in these clinical settings. Here, we review available data regarding the risks and benefits associated with various periprocedural anticoagulation management approaches when patients receiving DOACs undergo electrophysiologic procedures including cardioversion, ablation, and device implantation. This discussion is intended to provide clinicians with an overview of available evidence and best practices to minimize the risk of both thromboembolic and bleeding events in the periprocedural setting.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/terapia , Cardioversão Elétrica , Eletrodiagnóstico , Tromboembolia Venosa/prevenção & controle , Administração Oral , Fibrilação Atrial/complicações , Humanos , Tromboembolia Venosa/etiologia
20.
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