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1.
Artigo em Inglês | MEDLINE | ID: mdl-32462550

RESUMO

PURPOSE: The prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported. METHODS: Ablations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures. RESULTS: Seventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period. CONCLUSIONS: The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.

2.
J Cardiovasc Electrophysiol ; 30(10): 1860-1867, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31353679

RESUMO

BACKGROUND: Ablation of persistent atrial fibrillation (AF) remains challenging. Identification and ablation of localized AF drivers may offer the possibility for improved outcomes. Ripple map is a novel software algorithm that may allow improved localization of possible AF drivers through the whole chamber graphical display of continuously recorded bipolar electrograms. The objective of this study was to determine whether regions of high-frequency Ripple activation (HFRA) observed on Ripple map provide useful ablation targets in patients with persistent AF. METHODS AND RESULTS: Consecutive patients underwent the first-time ablation of persistent AF (n = 162) using a standard stepwise (n = 105) or a Ripple map guided approach (n = 57). Ripple map guided patients underwent pulmonary vein antral isolation followed by ablation of HFRA sites. Acute termination of AF was observed in 91.2% of the Ripple-guided patients vs 52.4% in the stepwise approach, P < .0001. Following a single ablation procedure, after 18 months 98.2% of Ripple map guided patients were free of AF, compared with 81.4% of standard stepwise ablation (P = .005). Freedom from atrial tachycardia (54.4% Ripple map vs 52.4% standard, P = .9) or any atrial arrhythmia (52.6% Ripple map vs 39.0% standard, P = .10) did not differ between the two strategies. In a subset analysis (n = 30 of 56), Ripple map regions corresponded to sites with spatiotemporal dispersion in all atrial locations. No differences were observed in the rate of procedural complications. CONCLUSIONS: Ablation of HFRA sites identified with Ripple map resulted in a higher rate of acute termination and improved freedom from AF compared to a standard stepwise approach.

3.
Europace ; 20(FI_3): f392-f400, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29016769

RESUMO

Aims: THERMOCOOL SMARTTOUCH® SF Catheter is a new contact-force (CF)-sensing catheter with 56-hole porous tip designed for improved cooling and reduced fluid delivery compared with a standard 6-hole open-irrigated catheter. The SMART SF study examined the periprocedural safety, acute effectiveness, and procedural efficiency of the catheter for drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) ablation. Methods and results: The prospective, open-label, non-randomized SMART-SF was conducted at 17 US sites. Circumferential pulmonary vein (PV) isolation was performed with confirmation of entrance block in all PVs. Stable ablation sites were identified using CARTO VISITAG™ Module. Primary adverse events (AEs; ≤1 week of index procedure), periprocedural AEs within 30 days of ablation procedure, acute effectiveness (confirmation of entrance block for targeted PVs), CF, and procedural parameters were assessed. Overall, 165 patients were enrolled (mean age, 62.7 years; male, 57.9%; white, 97%; left ventricular ejection fraction, 60.1 ± 7%; left atrium diameter, 38.8 ± 6 mm); 159 underwent radiofrequency ablation and comprised the safety cohort. Primary safety performance criteria were met: primary AE rate was 2.5% (4/159; cardiac tamponade [n = 2], thrombo-embolism [n = 1], transient ischaemic attack [n = 1]). All primary AEs resolved/improved within the 1-month follow-up period. Acute procedural effectiveness was attained in 96.2% (95% confidence interval: 92.0-98.6%) of patients. Procedure time, fluoroscopy time, and fluid delivered were observed in comparison to predecessor catheters. Conclusion: In the SMART-SF trial, the predetermined safety performance goal was met, demonstrating the safety and acute effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter for PAF ablation.


Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Ablação por Cateter/instrumentação , Frequência Cardíaca , Veias Pulmonares/cirurgia , Irrigação Terapêutica/instrumentação , Potenciais de Ação/efeitos dos fármacos , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Resistência a Medicamentos , Desenho de Equipamento , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Porosidade , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Fatores de Risco , Irrigação Terapêutica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
4.
J Interv Card Electrophysiol ; 49(2): 205-209, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28413855

RESUMO

PURPOSE: The aim of this study is to investigate the frequency of electrosurgery-related pacemaker malfunction. METHODS: A retrospective study was conducted to investigate electrosurgery-related pacemaker malfunction in consecutive patients undergoing pulse generator (PG) replacement or upgrade from two large hospitals in Minneapolis, MN between January 2011 and January 2014. The occurrence of this pacemaker malfunction was then studied by using MAUDE database for all four major device vendors. RESULTS: A total of 1398 consecutive patients from 2 large tertiary referral centers in Minneapolis, MN undergoing PG replacement or upgrade surgery were retrospectively studied. Four patients (0.3% of all patients), all with pacemakers from St Jude Medical (2.8%, 4 of 142) had output failure or inappropriately low pacing rate below 30 bpm during electrosurgery, despite being programmed in an asynchronous mode. During the same period, 1174 cases of pacemaker malfunctions were reported on the same models in MAUDE database, 37 of which (3.2%) were electrosurgery-related. Twenty-four cases (65%) had output failure or inappropriate low pacing rate. The distribution of adverse events was loss of pacing (59.5%), reversion to backup pacing (32.4%), inappropriate low pacing rate (5.4%), and ventricular fibrillation (2.7%). The majority of these (78.5%) occurred during PG replacement at ERI or upgrade surgery. No electrosurgery-related malfunction was found in MAUDE database on 862 pacemaker malfunction cases during the same period from other vendors. CONCLUSIONS: Electrosurgery during PG replacement or upgrade surgery can trigger output failure or inappropriate low pacing rate in certain models of modern pacemakers. Cautions should be taken for pacemaker-dependent patients.


Assuntos
Eletrocirurgia/efeitos adversos , Marca-Passo Artificial/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Fontes de Energia Elétrica , Falha de Equipamento , Humanos , Masculino , Minnesota , Reoperação , Estudos Retrospectivos
5.
JACC Clin Electrophysiol ; 2(6): 691-699, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29759747

RESUMO

OBJECTIVES: This study sought to assess the correlation between catheter and tissue contact force (CF) stability and 12-month clinical success for atrial fibrillation (AF) ablation. BACKGROUND: The SMART-AF (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation) multicenter trial provided a robust dataset of AF ablation procedures, using the CF sensing ablation catheter. METHODS: CF and CF stability were correlated with 12-month success for drug-refractory symptomatic AF ablation. CF stability was assessed by stability of ablation parameters (CF, time, location stability) over 3-dimensional electroanatomic maps of pulmonary veins (PVs) using a new proprietary software module and the percentage of time within investigator-selected CF ranges. Available data for potential "PV gaps" were retrospectively identified when stability criteria were not met and were correlated with 12-month success. RESULTS: Average CF categories of 0 to 10, 10 to 20, and >20 g were associated with 12-month success rates of 90%, 70%, and 70%, respectively; thus, higher average CF did not correlate with treatment success. An exploratory univariate analysis showed significantly higher success rates with a CF of 6.5 to 10.3 g than with <6.5 g (odds ratio: 2.95; 95% confidence interval: 1.13 to 7.72; p = 0.028) but a CF >10 g did not improve success. When stable CF was applied ≥73% of the time within the preselected CF range, success improved. A receiver operating characteristic curve analysis revealed that PV gaps exceeding 10.6-mm distance significantly correlated with 12-month failure. CONCLUSIONS: In the SMART-AF trial, CF stability with sufficient CF was most predictive of optimal 12-month success. (Thermocool Smarttouch Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation [SMART-AF]; NCT01385202).

6.
J Am Coll Cardiol ; 64(7): 647-56, 2014 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-25125294

RESUMO

BACKGROUND: Catheter ablation is important for treatment of paroxysmal atrial fibrillation (PAF). Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation. OBJECTIVES: The study sought to assess the safety and effectiveness of an irrigated, contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF. METHODS: A prospective, multicenter, nonrandomized study was conducted. Enrollment criteria included: ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug (Class I to IV). Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint. RESULTS: A total of 172 patients were enrolled at 21 sites, where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application. Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade (n = 4), pericarditis (n = 3), heart block (n = 1, prior to radiofrequency application), and vascular access complications (n = 4). By Kaplan-Meier analyses, 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5%. The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80% of the time during therapy, outcomes were 4.25 times more likely to be successful (p = 0.0054; 95% confidence interval: 1.53 to 11.79). CONCLUSIONS: The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF, with no unanticipated device-related adverse events. The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence. Stable CF during radiofrequency application increases the likelihood of 12-month success. (THERMOCOOL® SMARTTOUCH® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202).


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Cateteres , Sistema de Condução Cardíaco/cirurgia , Taquicardia Paroxística/cirurgia , Fibrilação Atrial/fisiopatologia , Eletrocardiografia , Desenho de Equipamento , Feminino , Seguimentos , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Taquicardia Paroxística/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
7.
Heart Rhythm ; 7(8): 1048-55, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20493965

RESUMO

BACKGROUND: The Medtronic Sprint Fidelis high-voltage implantable cardioverter-defibrillator (ICD) lead is prone to fracture. The majority of fractures involve the pace-sense (P/S) conductors and may result in multiple inappropriate shocks. The Medtronic lead integrity alert (LIA) algorithm was designed to improve early detection of transient P/S conductor fractures and to decrease the incidence and number of inappropriate shocks. OBJECTIVE: The purpose of this prospective single-center study was to assess the effectiveness of the LIA algorithm for warning patients of an impending Sprint Fidelis P/S conductor fracture and for decreasing the incidence and number of inappropriate shocks. METHODS: The study population included all patients who had Sprint Fidelis leads and Medtronic ICD pulse generators that were implanted and followed at the Minneapolis Heart Institute. Patients were evaluated in the clinic every 3 to 4 months or by remote monitoring using the Medtronic CareLink system. When the LIA algorithm was released in August 2008, the RAMware was downloaded to the pulse generator of all patients with the Sprint Fidelis lead. Patients and family members received educational materials and were given a demonstration of the audible alerts. RESULTS: Between October 2004 and January 2010, 52 (11.3%) of 461 Sprint Fidelis leads failed in the study population. Inappropriate shocks were the first sign of lead failure in 18 (69%) of the 26 patients who did not have the LIA compared to 4 (17%) of 23 patients who had the LIA (P = .0004). Patients who experienced inappropriate shocks without the LIA received an average of 13.2 +/- 13.6 inappropriate shocks (range 2-54) versus 3.0 +/- 2.0 inappropriate shocks (range 2-6) in patients who had the LIA (P = .017). The audible alert was effective in 70% (16/23) and 35% (6/17) of patients with and without the LIA, respectively, whose alerts were programmed ON (P = .053). Overall, 8 (32%) of 25 patients whose audible alerts were triggered did not immediately hear or recognize the tone. CONCLUSION: The LIA appears to be an effective method for detecting most Sprint Fidelis lead fractures and for decreasing the incidence and number of inappropriate shocks. However, a better method for alerting patients and caregivers is needed.


Assuntos
Algoritmos , Estimulação Cardíaca Artificial , Desfibriladores Implantáveis/efeitos adversos , Eletrodos Implantados/efeitos adversos , Falha de Equipamento , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
8.
Am J Cardiol ; 102(12): 1674-6, 2008 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-19064022

RESUMO

Radiofrequency ablation for atrial fibrillation (AF) involves complex catheter manipulation resulting in prolonged procedure time and fluoroscopy exposure. Remote magnetic navigation (RMN) represents a novel approach toward improving the ability to perform complex ablation. Forty patients underwent ablation for AF, 20 using RMN (NIOBE II, Stereotaxis, Inc) with a 4-mm-tip magnetic catheter (Celsius, Biosense Webster) and 20 using a conventional 8-mm-tip bidirectional ablation catheter (Blazer, Boston Scientific). All patients underwent a combined wide area circumferential ablation and segmental pulmonary vein (PV) isolation using a circular mapping catheter and cavotricuspid isthmus ablation for right atrial flutter. The procedural end point was PV entrance block. There was no difference in atrial size, left ventricular systolic function, or type of AF between groups. PV entrance block was achieved in all patients. Mean procedure time was 279 +/- 60 minutes in the conventional group versus 209 +/- 56 minutes in the RMN group (p <0.001). Mean fluoroscopy time in the conventional group was 58.6 +/- 21 minutes versus 19.5 +/- 9.8 in the RMN group (p <0.001). At 1 year there were 15 patients in the conventional group and 16 in the RMN group free from clinical AF and off antiarrhythmic drugs (p = NS). There were 2 additional ablations performed for atypical atrial flutter in the conventional group and 3 in the RMN group (p = ns). Ablation catheter char formation was not observed. There were no procedural complications. In conclusion, radiofrequency ablation of AF performed with RMN is safe and feasible. Compared with conventional hand-navigated ablation, RMN ablation results in similar clinical outcomes with decreased fluoroscopy and procedure times.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Magnetismo , Ablação por Cateter/instrumentação , Eletrocardiografia , Estudos de Viabilidade , Fluoroscopia , Humanos , Imageamento Tridimensional , Imagem por Ressonância Magnética
9.
Heart Rhythm ; 5(6): 775-9, 2008 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-18534361

RESUMO

BACKGROUND: The Medtronic Sprint Fidelis implantable cardioverter-defibrillator high-voltage lead is prone to fracture. The October 2007 safety advisory recommended lead impedance monitoring to aid in identifying lead fractures. OBJECTIVE: The aim of this single-center study was to examine the effectiveness of impedance monitoring for detecting Sprint Fidelis lead failures before they caused adverse clinical events such as inappropriate shocks. METHODS: Impedance and sensing information were acquired during routine clinic and CareLink follow-up and at the time of lead failure using the Patient Alert, sensing integrity counter, nonsustained episode, and electrogram features in Medtronic pulse generators. RESULTS: Between September 2004 and February 2008, 17 of 514 Sprint Fidelis leads (3.3%) followed up at our center failed between 11 and 35 months after implantation (mean 23.0 +/- 8.0 months). Fifteen of these failures (88%) were caused by pace-sense conductor fractures, and 2 (12%) were caused by high-voltage conductor defects. Twelve of 15 patients (80%) with pace-sense conductor fractures received inappropriate shocks; of these, 4 had no significant increase in lead impedance before they were shocked, 2 were shocked <3 hours after their lead impedances exceeded the 1,000 Omega audible alert threshold, and 2 patients did not hear the alarm. All pace-sense conductor failures whose sensing function could be evaluated (13 of 15) had oversensing based on stored data, and oversensing usually (11 of 13) preceded impedances changes. CONCLUSION: Impedance monitoring did not prevent inappropriate shocks in two-thirds of our patients. Thus, pace-sense conductor impedance monitoring as currently implemented does not reliably forewarn patients of a lead malfunction. Consequently, patients who have Sprint Fidelis leads remain at risk for adverse clinical events associated with pace-sense conductor fracture.


Assuntos
Cardiografia de Impedância , Desfibriladores Implantáveis/efeitos adversos , Cardiografia de Impedância/instrumentação , Eletrodos Implantados/efeitos adversos , Falha de Equipamento , Análise de Falha de Equipamento , Segurança de Equipamentos , Feminino , Humanos , Masculino , Estudos Retrospectivos
10.
Heart Rhythm ; 4(2): 128-35, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17275744

RESUMO

BACKGROUND: Movement to upright posture may result in marked drop of blood pressure with susceptibility to injury from syncope and falls in patients with orthostatic hypotension. OBJECTIVE: The purpose of this study was to determine if increasing negative intrathoracic pressure by using an inspiratory impedance threshold device before change of posture diminishes blood pressure fall by enhancing venous return. METHODS: Eighteen healthy subjects and 22 orthostatic hypotension patients were randomized to either an active (impedance 7 cmH2O) or sham (no inspiratory impedance) impedance threshold device. Arterial blood pressure, heart rate, and estimated stroke volume and total peripheral resistance were recorded in the supine and upright postures using a noninvasive finger arterial blood pressure monitor. After a rest period, the alternate impedance threshold device (sham or active) was tested in each individual. RESULTS: Compared with the sham impedance threshold device test, the active impedance threshold device resulted in significant reduction in the magnitude of upright posture-induced fall in blood pressure and a greater increase of total peripheral resistance after standing in both healthy subjects and orthostatic hypotension patients. Stroke volume was not measurably altered. Among all subjects who exhibited a postural blood pressure drop >10 mmHg on the day of study, active impedance threshold device treatment consistently blunted blood pressure fall during the initial 100 seconds after standing (<0.04). Induced orthostatic symptoms were less severe with the active impedance threshold device both at onset of upright posture and during 30 seconds of standing. CONCLUSION: Enhancing impedance to inspiration may prove useful as adjunctive therapy for diminishing symptoms associated with movement to upright posture in individuals with orthostatic hypotension.


Assuntos
Cardiografia de Impedância/instrumentação , Hipotensão Ortostática/fisiopatologia , Hipotensão Ortostática/terapia , Inalação/fisiologia , Postura/fisiologia , Adulto , Feminino , Frequência Cardíaca/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Movimento/fisiologia , Projetos Piloto , Volume Sistólico/fisiologia , Resultado do Tratamento
11.
Curr Cardiol Rep ; 6(5): 385-90, 2004 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-15306096

RESUMO

Neurally mediated reflex syncope (sometimes referred to as neurocardiogenic syncope), encompasses a group of disorders of which the best known and most frequently occurring forms are the vasovagal (or common) faint, and carotid sinus syndrome. Postmicturition syncope, defecation syncope, cough syncope, and other situational reflex faints are also included among these conditions. With the exception of carotid sinus syndrome in which cardiac pacing is effective, treatment of most neurally mediated reflex faints is shifting from reliance on various drugs to greater emphasis on education and nonpharmacologic therapy. Initial management should include counseling of patients regarding recognition of early warning symptoms, and avoidance of precipitating factors. Volume expansion with salt tablets or electrolyte-containing beverages and patient education on how to perform isometric arm contractions and/or leg crossing in order to abort impending syncope are also important. Thereafter, tilt-training has demonstrated benefit in several clinical studies. When symptoms remain despite the above-noted interventions, pharmacologic therapy with midodrine or a nonselective b-blocker can be considered. In the case of most neurally mediated reflex faints, permanent cardiac pacing should be reserved only for those older patients with significant bradycardia or asystole at time of syncope when all other interventions have failed.


Assuntos
Síncope Vasovagal/prevenção & controle , Estimulação Cardíaca Artificial , Ensaios Clínicos como Assunto , Eletrólitos/uso terapêutico , Humanos , Educação de Pacientes como Assunto , Postura , Fatores Desencadeantes , Sódio na Dieta/uso terapêutico , Síncope Vasovagal/diagnóstico
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