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1.
Artigo em Inglês | MEDLINE | ID: mdl-32147799

RESUMO

BACKGROUND: Second-generation cryoballoon ablation is safe and effective in patients with persistent atrial fibrillation (AF). The aim of this study is to report the real long-term AF burden and freedom from AF post-cryoablation using continuous monitoring, and to assess whether intraoperative confirmation of pulmonary vein isolation using electrical mapping is necessary. METHODS: A total of 33 patients (mean age 75.7 ± 5.6 years, 16 men) with persistent AF who underwent second-generation cryoablation without electrical mapping were reviewed. All patients had a cardiac implantable device and were followed up for a mean of 755 ± 170 days. RESULTS: AF burden significantly decreased from 67.51% ± 34.90% to 18.28% ± 26.65% at 1-year follow-up, and this reduction was maintained at final follow-up (18.26% ± 23.70%, p < 0.001). Continuous monitoring revealed a freedom from AF rate of 33% and 24% at 1-year and full follow-up, respectively. Patients who remained in persistent AF at final follow-up had a trend towards higher pre-ablation AF burden (81.6% ± 29.7% vs 57.3% ± 36.4%, p = 0.08). CONCLUSION: Second-generation cryoablation without confirming pulmonary vein isolation using electrical mapping is effective leading to significant reductions in AF burden based on continuous beat-to-beat monitoring at 1-year and long-term follow-up.

2.
Europace ; 21(10): 1459-1467, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31377792

RESUMO

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.

3.
Int J Clin Pract ; : e13410, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31464020

RESUMO

OBJECTIVE: To investigate the accuracy of three non-invasive blood pressure (BP) devices in atrial fibrillation (AF) compared with invasive arterial BP. METHODS: One hundred patients aged 45-90 years, 63% male (50 in AF and 50 age matched controls in sinus rhythm [SR]) were identified with arterial lines measuring beat-to-beat BP fluctuation. Non-invasive BP measurements utilising the manual sphygmomanometer (MS), PulseCor R6.5 (PC) and automated sphygmomanometer (AS) were taken simultaneously with invasive BP in a randomised sequence. This was repeated three times in each patient. RESULTS: In SR differences in systolic BP (SBP) for MS, AS and PC were -0.34 mm Hg (95% CI -2.31 to 1.63; P = .733), -3.80 mm Hg (95% CI -5.73 to -1.87; P = .0001) and -3.90 mm Hg (95% CI -5.90 to -1.90; P = .0001) and for diastolic BP (DBP) were 6.02 mm Hg (95% CI 4.39-7.64; P < .0001), 8.95 mm Hg (95% CI 7.36-10.55; P < .0001) and 7.54 mm Hg (95% CI 5.89-9.18; P < .0001), respectively. In AF mean differences in SBP for MS, AS and PC were -7.33 mm Hg (95% CI -9.11 to -5.55; P < .0001), -5.29 mm Hg (95% CI -7.08 to -3.50; P < .0001) and -5.75 mm Hg (95% CI -7.54 to -3.96; P < .0001) respectively and for DBP were 5.28 mm Hg (95% CI 4.03-6.54; P < .0001), 6.26 mm Hg (95% CI 5.00-7.52; P < .0001) and 6.89 mm Hg (95% CI 5.64-8.15; P < .0001) respectively. CONCLUSIONS: The MS is accurate in SR because of direct assessment of Korotkoff sounds. Non-invasive BP assessment in AF is significantly less accurate. These findings have important prognostic and therapeutic implications.

4.
J Clin Hypertens (Greenwich) ; 21(9): 1399-1405, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31347773

RESUMO

A central iliac arteriovenous anastomosis, termed the "coupler" (ROX Medical), results in a significant reduction in blood pressure (BP) in hypertensive patients. This study assessed functional and hemodynamic changes induced by the device. Twenty-one patients with resistant and/or uncontrolled hypertension underwent stress echocardiography and cardiopulmonary exercise testing (CPET) at baseline and 6 months post-coupler implantation. End points were selected to best evaluate cardiac function including Doppler stroke volume (SV), septal and lateral E/E', and right ventricular systolic velocity S' (RV S'). CPET VO2 peak demonstrated total cardiopulmonary performance. SV increased from 76.4 SD12.2 mL to 92.1 SD22.7 mL 6 months post-coupler insertion; P = .002. No changes in RV S', septal or lateral E/E', or VO2 peak were observed. Five patients experienced increased diuretic requirement ≥3 times baseline. RV S' fell from 19.0 SD1.87 cm/s to 16.80 SD3.43 cm/s in these patients (P > .05). A significant increase in SV 6 months post-coupler insertion was observed. In patients with increased diuretic requirement, the device was associated with a lower RV S' suggesting occult RV dysfunction as the mechanism of this pre-specified adverse outcome.

5.
Clin Respir J ; 13(5): 280-288, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30793493

RESUMO

BACKGROUND: Sleep-disordered breathing (SDB) and atrial fibrillation (AF) are associated. This study investigated the impact of AF intervention on 6-month home sleep testing data. METHODS: Sixty-seven patients (aged 66 to 86, 53% male) with persistent AF were randomized (1:1:1) to direct current cardioversion (DCCV) (22 patients), permanent pacemaker (PPM) + atrioventricular node ablation (AVNA) + DCCV (22 patients) or AF ablation (23 patients). Baseline and 6-month multichannel home sleep tests with the Watch-PAT200 (Itamar Medical Lts., Caesarea, Israel) were recorded. Implantable cardiac monitors (ICMs) (Medtronic Reveal XT, Minneapolis, Minnesota) in the DCCV and AF ablation groups, and PPM Holters in the 'pace and ablate' group were utilized to assess cardiac rhythm beat-to-beat throughout the study period. RESULTS: The prevalence of moderate-to-severe SDB [apnoea-hypopnoea index (AHI) ≥ 15/h] was 60%. At 6 months there was no change in AHI, Epworth sleepiness scale, sleep time, % REM sleep, respiratory desaturation index or central apnoeic events. Twenty-five patients (15 AF ablation, 9 DCCV and 1 following DCCV post-AVNA) maintained SR at 6 months confirmed on ICMs in these patients. AHI fell from 29.8 ± 26.6/h to 22.2 ± 20.4/h; P = 0.049. CONCLUSIONS: SDB is highly prevalent in patients with persistent AF. Restoration of sinus rhythm, and the associated long-term recovery of haemodynamics, is associated with a significant reduction in AHI. This implicates reversal of fluid shift from the lower limbs to the neck region, a key mechanism in the pathogenesis of SDB.


Assuntos
Fibrilação Atrial/complicações , Fibrilação Atrial/terapia , Síndromes da Apneia do Sono/complicações , Síndromes da Apneia do Sono/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Ablação por Cateter , Cardioversão Elétrica , Eletrocardiografia Ambulatorial , Feminino , Humanos , Masculino , Marca-Passo Artificial , Polissonografia , Prevalência , Síndromes da Apneia do Sono/epidemiologia
6.
Artigo em Inglês | MEDLINE | ID: mdl-30741360

RESUMO

PURPOSE: Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to 'gold standard' monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor 'R' Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated. METHODS: Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated. RESULTS: RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001). CONCLUSIONS: All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications.

7.
Am Heart J ; 207: 86-87, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30414626

RESUMO

A central iliac arteriovenous anastomosis, the 'coupler' (ROX Medical, California, USA) results in a significant reduction in blood pressure in hypertensive patients. This study assessed the change in AF burden following coupler implantation in patients with paroxysmal AF (PAF) and hypertension. Good blood pressure control using the coupler results in a significant reduction in AF burden.


Assuntos
Derivação Arteriovenosa Cirúrgica/métodos , Fibrilação Atrial/cirurgia , Hipertensão/cirurgia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Feminino , Humanos , Hipertensão/diagnóstico , Artéria Ilíaca , Veia Ilíaca , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
8.
J Interv Card Electrophysiol ; 51(3): 191-197, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29460236

RESUMO

PURPOSE: The ultrarapid delayed rectifier current (IKur) carried by Kv1.5 channels, which are solely expressed in the atrium, is a potential target for safer treatment of paroxysmal atrial fibrillation (PAF). XEN-D0103 is a nanomolar ion channel blocker that selectively inhibits potassium ion flux through the Kv1.5 ion channel. The efficacy of XEN-D0103 in reducing AF burden was assessed in patients with DDDRp permanent pacemakers (PPMs) and PAF. METHODS: A double-blind, placebo-controlled, cross-over study was performed in patients with PAF and DDDRp PPMs with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up. All anti-arrhythmic drugs were withdrawn before randomised treatment. After baseline assessment, patients were randomly assigned to two treatment periods of placebo then XEN-D0103 50 mg bd, or XEN-D0103 50 mg bd then placebo. RESULTS: Fifty-four patients were screened and 21 patients were eligible and included in the randomised trial. All 21 patients completed both treatment periods. The primary endpoint was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with XEN-D0103 versus placebo. There was a reduction in the mean frequency of AF episodes (relative reduction 0.72, 95% CI 0.66 to 0.77; p < 0.0001). XEN-D0103 was safe and well tolerated, and there were no serious adverse events. XEN-D0103 did not have any apparent effect on heart rate compared to placebo. CONCLUSIONS: XEN-D0103 did not reduce AF burden in patients with PAF and dual chamber pacemakers providing beat-to-beat monitoring. XEN-D0103 was well tolerated and did not have any apparent effect on heart rate. Although single-ion channel blockade with XEN-D0103 did not affect AF in this study, there might be a potential for this agent to be used in combination with other atrially specific drugs in the treatment of AF. EUDRACT TRIAL REGISTRATION NUMBER: 2013-004456-38.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Canais de Potássio de Retificação Tardia/antagonistas & inibidores , Monitorização Fisiológica/métodos , Marca-Passo Artificial/estatística & dados numéricos , Bloqueadores dos Canais de Potássio/uso terapêutico , Idoso , Antiarrítmicos/administração & dosagem , Antiarrítmicos/farmacologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Terapia Combinada , Estudos Cross-Over , Método Duplo-Cego , Eletrocardiografia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente/estatística & dados numéricos , Seleção de Pacientes , Prognóstico , Estudos Prospectivos , Resultado do Tratamento
9.
Europace ; 20(FI_3): f384-f391, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29092038

RESUMO

Aims: To investigate the effect of minimally invasive thoracoscopic surgical ablation and nMARQ irrigated multi-electrode phased radiofrequency (RF) ablation to treat paroxysmal atrial fibrillation (AF) compared with PVAC multi-electrode phased RF ablation, with beat-to-beat device-derived Holter monitoring throughout the study duration. Methods and results: An investigator-initiated prospective trial of patients with paroxysmal AF randomized (1:1:1) to initial surgical, nMARQ or PVAC ablation. All patients had continuous beat-to-beat monitoring with an ILR or pacemaker to evaluate and document AF recurrence. There was a strong trend (P = 0.050) toward difference in AF outcome, with surgical AF ablation more efficacious than catheter ablation. At one year, the proportion of patients with less than 1% AF burden after one procedure and off all antiarrhythmic drugs was 63, 56, and 90% for PVAC, nMARQ and surgical ablations respectively. There were significantly more repeat ablations in the catheter ablation groups (P = 0.008): 25% PVAC, 27% nMARQ, 0% surgery. However, 7 of 20 (35%) of patients undergoing surgical ablation suffered a procedural complication, including two sternotomies for bleeding and one death. This was higher than for catheter ablation (P < 0.001). Surgical ablation took longer to perform (P < 0.001) and had a longer hospital admission (P < 0.001) than catheter ablation. Conclusion: Surgical AF ablation required significantly fewer repeat procedures than catheter ablation, and there was a clear trend towards improved arrhythmia outcome. However, it was associated with a significantly higher rate of procedural complications. Surgical ablation for paroxysmal AF is promising, however more prospective outcome data is required. Clinical Trial Registration: NCT01504451, http://clinicaltrials.gov/show/NCT01504451.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Sistema de Condução Cardíaco/cirurgia , Cirurgia Torácica Vídeoassistida/métodos , Potenciais de Ação , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/mortalidade , Eletrocardiografia Ambulatorial , Inglaterra , Feminino , Sistema de Condução Cardíaco/fisiopatologia , Frequência Cardíaca , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Intervalo Livre de Progressão , Estudos Prospectivos , Recidiva , Reoperação , Fatores de Risco , Cirurgia Torácica Vídeoassistida/efeitos adversos , Cirurgia Torácica Vídeoassistida/mortalidade , Fatores de Tempo
10.
Hypertension ; 70(6): 1099-1105, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-29061728

RESUMO

Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP ≥140 mm Hg and average daytime ambulatory BP ≥135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone. At 12 months, 39 patients who had coupler therapy were included in the intention-to-treat analysis. Office-based systolic BP reduced by 25.1±23.3 mm Hg (baseline, 174±18 mm Hg; P<0.0001) post-coupler placement, and office diastolic BP reduced by 20.8±13.3 mm Hg (baseline, 100±13 mm Hg; P<0.0001). Mean 24-hour ambulatory BP reduced by 12.6±17.4/15.3±9.7 mm Hg (P<0.0001 for both). In a prespecified subset of patients who failed to respond adequately to prior renal denervation, coupler therapy led to highly significant reduction in office systolic/diastolic BP (30.7/24.1 mm Hg) and significant reduction in 24-hour ambulatory systolic/diastolic BP (12.4/14.4 mm Hg) at 12 months (n=9). After coupler therapy, 14 patients (33%) developed ipsilateral venous stenosis; all were treated successfully with venous stenting. These findings confirm the importance of arterial mechanics in the pathophysiology of hypertension and support the clinical use of a central iliac arteriovenous anastomosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.


Assuntos
Pressão Sanguínea/fisiologia , Hipertensão/cirurgia , Artéria Ilíaca/cirurgia , Veia Ilíaca/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Derivação Arteriovenosa Cirúrgica/métodos , Monitorização Ambulatorial da Pressão Arterial , Feminino , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Adulto Jovem
11.
Echo Res Pract ; 4(3): 37-44, 2017 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-28611061

RESUMO

Background: The rate of progression of aortic regurgitation (AR) is not well described. Current guidelines state that asymptomatic patients with mild AR should be followed up every 3­5 years and 1­2 yearly for moderate AR. This study describes the lesion and clinical based progression of mild and moderate AR in a population of patients undergoing systematic follow-up. Methods and results: 341 patients with either mild or moderate AR were included. The rates of clinical events (death, aortic valve replacement and cardiac hospitalization) and progression of AR are reported. 341 patients were included; mean age was 71.1 years (IQR 66­80 years) and the median follow-up period was 4.6 (IQR 2­6.7) years. 292 patients did not have any events during follow-up. 3 patients required aortic valve replacement (2 of these due to severe aortic stenosis and 1 due to severe mitral regurgitation and co-existent moderate AR). 44 patients required cardiac hospitalization. 9 patients died during follow-up and 35 patients (10%) showed a progression of AR during follow-up with an average time of 4.0 ± 2.6 years. 8 patients (2.3% of the total) progressed to severe AR. Patients with mixed valvular pathology showed a greater increase in AR progression (27 (15%) vs 8 (5%); P = 0.004). Conclusions: Over medium term systematic follow-up progression and clinical events in patients with AR is rare, regardless of etiology. Patients who suffered from AR as an isolated valve pathology were less likely to show AR progression over time.

12.
J Atr Fibrillation ; 8(6): 1388, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27909499

RESUMO

Threshold testing of cardiac rhythm devices is essential to monitoring the proper functioning of such devices (1). However, the currently method of applying multiple ECG leads to the patient is burdensome and time consuming (2). We are presenting a completely new way to perform cardiac rhythm device threshold testing using pulse oximetry. Twenty patients, with varying cardiac rhythm devices and pacing modes, were enrolled and had their atrial and ventricular thresholds tested. A comparison was made between simultaneous threshold determinations via the standard EGM based method and the new pulse oximetry based method. 75% of the ventricular threshold tested and 58% of the atrial thresholds tested were the same with the two testing methods. The remainder of the tests (25% of ventricular threshold and 42% of the atrial threshold tests) varied by +0.25 V. This study shows that pulse oximetry based testing is an accurate, reliable, and easy way to perform cardiac rhythm device threshold testing and may complement traditional methods to perform such tests in the future.

13.
J Am Heart Assoc ; 5(12)2016 12 21.
Artigo em Inglês | MEDLINE | ID: mdl-28003251

RESUMO

BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an arteriovenous anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH. METHODS AND RESULTS: The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932). CONCLUSIONS: Our data suggest that creation of an arteriovenous anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.


Assuntos
Derivação Arteriovenosa Cirúrgica/métodos , Pressão Sanguínea/fisiologia , Hipertensão/cirurgia , Artéria Ilíaca/cirurgia , Veia Ilíaca/cirurgia , Monitorização Ambulatorial da Pressão Arterial , Feminino , Seguimentos , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
15.
BMJ Case Rep ; 20162016 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-26791131

RESUMO

The ROX Coupler is a device that allows creation of a central arteriovenous anastomosis at the iliac level. The device has been shown to improve exercise capacity in patients with chronic obstructive pulmonary disease and is CE marked for the treatment of resistant and uncontrolled hypertension. Reflex syncope is a challenging clinical condition with limited proven therapeutic options. We describe the resolution of symptoms and tilt table response of a patient who underwent insertion of a ROX Coupler to treat hypertension, and also incidentally had pre-existing vasodepressor syncope.


Assuntos
Hipertensão/cirurgia , Síncope Vasovagal/diagnóstico , Síncope Vasovagal/cirurgia , Idoso , Anastomose Arteriovenosa/cirurgia , Feminino , Humanos , Hipertensão/fisiopatologia , Reflexo , Síncope Vasovagal/fisiopatologia , Teste da Mesa Inclinada/métodos , Resultado do Tratamento
16.
Europace ; 18(6): 912-8, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26462702

RESUMO

AIMS: This prospective randomized controlled study evaluated the first-line use of a novel remotely monitored implantable loop recorder (ILR) in the initial investigation of unexplained syncope, and compared this to conventional therapy and a dedicated Syncope Clinic (SC). METHODS AND RESULTS: A total of 246 patients (mean age 70.3 years) were randomly allocated to conventional management, SC alone, ILR alone, or SC + ILR. Median follow-up was 20 months (IQR 15-25 months). Time to electrocardiogram (ECG) diagnosis was significantly shorter with ILR alone vs. conventional [hazard ratio (HR) 35.5, P = 0.0004] and with SC vs. conventional (HR 25.6, P = 0.002). Seventy-four per cent of first syncopal events documented in the SC groups occurred during provocative tilt testing. Twenty-two per cent of patients who received an ILR were found to have a bradycardia indication for permanent pacing, compared with 3% of patients who did not. Overall, more investigative tests were undertaken in the conventional group than in any other. Only patients who received an ILR had a significant increase in time to second syncope (P = 0.02), suggesting successful diagnosis and management of treatable causes of syncope. CONCLUSIONS: Implantable loop recorder monitoring achieved a more rapid diagnosis in unexplained syncope than usual care. Conventional management of syncope failed to achieve an ECG diagnosis despite a large number of investigative tests. Syncope Clinic and provocative tilt testing delivered a rapid ECG diagnosis, but did not prevent recurrent syncope. Implantable loop recorders offered rapid diagnosis, increased the likelihood of syncope being reported, demonstrated a high rate of intermittent bradycardia requiring pacing, and reduced recurrent syncope.


Assuntos
Bradicardia/diagnóstico , Eletrocardiografia Ambulatorial/instrumentação , Eletrodos Implantados , Síncope/etiologia , Síncope/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial , Modelos de Riscos Proporcionais , Estudos Prospectivos , Recidiva , Teste da Mesa Inclinada , Reino Unido
17.
Europace ; 18(3): 340-6, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26462707

RESUMO

AIMS: To assess the efficacy of BMS 914392 on atrial fibrillation (AF) burden reduction in 20 patients with pacemakers and paroxysmal atrial fibrillation (PAF). BMS 914392 is a potent, selective, oral inhibitor of the IKACh current and has been shown to suppress AF, whilst having no effect on the ventricular refractory period. This is the first efficacy study of BMS 914392 in patients with PAF. METHODS AND RESULTS: The study was a four-way, crossover, double-blind design. A total of 20 patients with PAF and dual-chamber pacemakers were recruited. The pacemakers allowed beat-to-beat monitoring. Anti-arrhythmic drugs were withdrawn. Patients received low-dose (10 mg OD), medium-dose (10 mg TDS), and high-dose (20 mg TDS) BMS 914392 or placebo for 3 weeks before being crossed to the next phase. Patients underwent a washout period, four treatment phases and a final washout phase. Atrial fibrillation burden was downloaded from their pacemakers at the end of each study phase. BMS 914392 did not reduce AF burden when compared with placebo (10 mg OD P = 0.56, 10 mg TDS P = 0.22, 20 mg TDS P = 0.23). Heart rate and corrected QT (QTc) were not affected by BMS 914392. Adverse event (AE) rates did not differ from placebo in any of the treatment groups, with no serious AEs recorded. CONCLUSION: BMS 914932 has not been shown to reduce AF burden in patients with PAF and pacemakers using beat-to-beat pacemaker monitoring throughout the study. BMS 914392 was well tolerated and did not affect QTc or reduce heart rate. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01356914.


Assuntos
Antiarrítmicos/uso terapêutico , Fibrilação Atrial/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Canais de Potássio Corretores do Fluxo de Internalização Acoplados a Proteínas G/antagonistas & inibidores , Sistema de Condução Cardíaco/efeitos dos fármacos , Frequência Cardíaca/efeitos dos fármacos , Bloqueadores dos Canais de Potássio/uso terapêutico , Piranos/uso terapêutico , Quinolinas/uso terapêutico , Potenciais de Ação , Idoso , Antiarrítmicos/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Estudos Cross-Over , Método Duplo-Cego , Eletrocardiografia , Inglaterra , Feminino , Canais de Potássio Corretores do Fluxo de Internalização Acoplados a Proteínas G/metabolismo , Sistema de Condução Cardíaco/metabolismo , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Bloqueadores dos Canais de Potássio/efeitos adversos , Piranos/efeitos adversos , Quinolinas/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
18.
Europace ; 18(7): 1000-5, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26585596

RESUMO

AIMS: Implantable devices are widely accepted, but not proven, to be the most reliable monitoring method to assess atrial fibrillation (AF) therapies. We compared REVEAL(®)XT implantable cardiac monitors (ICMs) and permanent pacemakers (PPMs). METHODS AND RESULTS: Fifty patients with paroxysmal AF were randomized to ICM or PPM implant 6 weeks prior to pulmonary vein isolation. Permanent pacemakers were programmed to monitoring only (ODO). Device downloads were performed at 0, 3, 6, 9, and 12 months. All patients underwent 7-day external loop recorder. Device ECGs and EGMs were compared for AF burden. A total of 20 744 and 11 238 arrhythmia episodes were identified in the ICM and PPM groups, respectively. Correct identification of AF was significantly better in the PPM group (97 vs. 55% P < 0.001). In the ICM group, 26% of ECGs were un-interpretable. Sensitivity and specificity for each episode of AF was significantly better in the PPM group (100 vs. 79% and 98 vs. 66%, respectively, P < 0.001). The positive predictive value for the detection of any AF was significantly better in the PPM than the ICM (100 vs. 58%, P = 0.03). The negative predictive value for the absence of all AF was not significantly different between the PPM and ICM (100% vs. 92%, P = 0.76). CONCLUSION: Permanent pacemakers Holters are the most accurate method of evaluating arrhythmia burden and the therapeutic efficacy of novel AF therapies. ICM has a high degree of artefact, which reduces its specifity and sensitivity. Despite the deficiencies of ICM monitoring the negative predictive value of the ICM is satisfactory if zero AF burden is the aim of therapy.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Marca-Passo Artificial , Próteses e Implantes , Idoso , Ablação por Cateter/efeitos adversos , Eletrocardiografia Ambulatorial/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Veias Pulmonares/cirurgia , Sensibilidade e Especificidade , Reino Unido
19.
Europace ; 17(6): 864-70, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26023175

RESUMO

AIMS: To describe the long-term patterns of atrial fibrillation (AF) in patients with permanent pacemakers. METHODS AND RESULTS: A total of 2092 pacemaker Holter downloads were analysed in 323 patients with dual chamber permanent pacemakers, describing a cumulative 1031 patient-years of beat-to-beat monitoring. Four subtypes of AF were applied: (i) non-progressive low-burden PAF (NPLB-PAF, n = 120): such patients never have >1% AF burden throughout follow-up; (ii) chronic progressive PAF (CP-PAF, n = 55): AF burden increases but is never 100%; (iii) relapsing-remitting PAF (RR-PAF, n = 78): AF burden has reduced at least once by more than 2% and is never 100%; (iv) persistent AF (PersAF, n = 70): 100% AF burden for at least 28 days. Overall, mean AF burden rose 0.34% per year (P < 0.0001). After accounting for age, heart failure (HF) had a significant interaction with AF burden (P = 0.0022), but HATCH score and CVA/TIA did not. There were no differences in the frequency or duration of monitoring between the four AF subtypes. Atrial fibrillation episode frequency discriminated between subtypes (P = 0.0004). Eighteen of 70 (26%) patients with PersAF had pacemaker documented episodes of sinus rhythm (i.e. reversion to 'paroxysmal AF') after the onset of PersAF. CONCLUSION: In this cohort, the development of AF over time appears more complex than current definitions suggest. Atrial fibrillation can remain low burden without progression, remit-relapse, or progress as is described in currently accepted definitions. More frequent episodes of AF indicated a favourable subtype. Persistent AF is not inevitable, and can revert to paroxysmal AF. CLINICAL TRIAL REGISTRATION: NCT02016950, http://clinicaltrials.gov/show/NCT02016950.


Assuntos
Fibrilação Atrial/fisiopatologia , Bloqueio Atrioventricular/terapia , Eletrocardiografia Ambulatorial , Marca-Passo Artificial , Síndrome do Nó Sinusal/terapia , Fatores Etários , Idoso , Fibrilação Atrial/epidemiologia , Bloqueio Atrioventricular/epidemiologia , Estudos de Coortes , Progressão da Doença , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Ataque Isquêmico Transitório/epidemiologia , Masculino , Análise Multivariada , Estudos Retrospectivos , Síndrome do Nó Sinusal/epidemiologia , Acidente Vascular Cerebral/epidemiologia
20.
J Interv Card Electrophysiol ; 43(1): 91-8, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25711952

RESUMO

PURPOSE: C-reactive protein (CRP) is known to be strongly associated with atrial fibrillation (AF). However, it is not clear if CRP is a causal factor for AF. ISIS-CRPRx is a novel antisense oligonucleotide that reduces CRP production by specifically inhibiting mRNA translation. The effect of ISIS-CRPRx on AF was evaluated. METHODS: A double-blind phase II trial of ISIS-CRPRx in patients with paroxysmal AF and DDDRP permanent pacemakers (PPMs) with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up. RESULTS: Twenty six patients were screened and seven patients dosed with ISIS-CRPRx. After 4 weeks of baseline assessment, patients were randomly assigned to two treatment periods of either placebo then ISIS-CRPRx or ISIS-CRPRx then placebo. All patients were followed up for 8 weeks after the active treatment period. There was a 63.7 % (95 % CI 38.4 to 78.6 %, p = 0.003) relative reduction in CRP on treatment with ISIS-CRPRx versus baseline. Sensitivity analyses demonstrated a consistent treatment effect. The primary end-point was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with ISIS-CRPRx versus baseline (OR 1.6, 95 % CI -2.42 to 5.62, p = 0.37). ISIS CRPRx was safe and well tolerated and there were no serious adverse events. CONCLUSIONS: Treatment with ISIS-CRPRx did not reduce AF burden in patients with paroxysmal AF and PPMs, despite a large relative reduction in CRP. In this population, highly specific CRP reduction had no clinically discernable effect upon paroxysmal AF. However, average levels of CRP at baseline were relatively low, so it remains possible that AF patients with higher levels of CRP may benefit from CRP-directed therapy.


Assuntos
Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Proteína C-Reativa/análise , DNA Antissenso/uso terapêutico , Eletrocardiografia Ambulatorial , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/genética , Biomarcadores/sangue , Proteína C-Reativa/genética , DNA Antissenso/genética , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Resultado do Tratamento
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