Browsing by Author "Piccini, Jonathan P"
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Item Open Access Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.(Circulation, 2021-04) Packer, Douglas L; Piccini, Jonathan P; Monahan, Kristi H; Al-Khalidi, Hussein R; Silverstein, Adam P; Noseworthy, Peter A; Poole, Jeanne E; Bahnson, Tristram D; Lee, Kerry L; Mark, Daniel B; CABANA InvestigatorsBackground
In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).Methods
The CABANA trial randomized 2204 patients with AF who were ≥65 years old or <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >II at baseline and form the subject of this article. The CABANA trial's primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest.Results
Of the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2).Conclusions
In patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508; Unique identifier: NCT0091150.Item Open Access Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis.(Heart rhythm, 2015-06) Zeitler, Emily P; Pokorney, Sean D; Zhou, Ke; Lewis, Robert K; Greenfield, Ruth Ann; Daubert, James P; Matchar, David B; Piccini, Jonathan PBackground
The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates of cable externalization (CE) and electrical failure (EF). The overall rates of these complications remain unknown.Objective
The purpose of this study was to systematically search the literature for rates of Riata lead failure and to perform a meta-analysis to estimate failure rates.Methods
We conducted a meta-analysis of observational studies examining the rates of EF, CE, and the interaction of the two. We identified 23 English language manuscripts addressing 1 or more of these questions.Results
Across 23 studies, the overall CE rate was 23.1% (95% confidence interval [CI] 19.0%-27.6%). The overall EF rate was 6.3% (95% CI 4.7%-8.2%). The presence of CE was associated with a more than 6-fold increase in the rate of EF compared to no CE (17.3% [95% CI 11.2%-25.9%] vs 2.7% [95% CI 1.4%-5.2%], respectively). The rate of CE was 3-fold higher for 8Fr leads compared to 7Fr leads, but rates of EF were similar (4.6%; 95% CI 3.2-6.6] and 3.9%; 95% CI 2.4-6.1], respectively). Rates of both CE and EF were higher in dual coil vs single coil leads, but confidence intervals overlapped.Conclusion
In clinical practice, rates of CE in Riata leads are substantial. While CE is associated with a significant increase in the risk of EF, the incidence of EF without externalization is not trivial.Item Open Access Catheter ablation of atrial fibrillation in patients with diabetes mellitus.(Heart rhythm O2, 2020-08) Wang, Allen; Truong, Tracy; Black-Maier, Eric; Green, Cynthia; Campbell, Kristen B; Barnett, Adam S; Febre, Janice; Loring, Zak; Al-Khatib, Sana M; Atwater, Brett D; Daubert, James P; Frazier-Mills, Camille; Hegland, Donald D; Jackson, Kevin P; Jackson, Larry R; Koontz, Jason I; Lewis, Robert K; Pokorney, Sean D; Sun, Albert Y; Thomas, Kevin L; Bahnson, Tristam D; Piccini, Jonathan PBackground
Diabetes mellitus (DM) is an independent risk factor for atrial fibrillation (AF). Few studies have compared clinical outcomes after catheter ablation between patients with and those without DM.Objective
The purpose of this study was to compare AF ablation outcomes in patients with and those without DM.Methods
We performed a retrospective analysis of 351 consecutive patients who underwent first-time AF ablation. Clinical outcomes included freedom from recurrent atrial arrhythmia, symptom burden (Mayo AF Symptom Inventory score), cardiovascular and all-cause hospitalizations, and periprocedural complications.Results
Patients with DM (n = 65) were older, had a higher body mass index, more persistent AF, more hypertension, and larger left atrial diameter (P <.05 for all). Median (Q1, Q3) total radiofrequency duration [64.0 (43.6, 81.4) minutes vs 54.3 (39.2, 76.4) minutes; P = .132] and periprocedural complications (P = .868) did not differ between patients with and those without DM. After a median follow-up of 29.5 months, arrhythmia recurrence was significantly higher in the DM group compared to the no-DM group after adjustment for baseline differences (adjusted hazard ratio [HR] 2.24; 95% confidence [CI] 1.42-3.55; P = .001). There was a nonsignificant trend toward higher AF recurrence with worse glycemic levels (HR 1.29; 95% CI 0.99-1.69; P = .064).Conclusion
Although safety outcomes associated with AF ablation were similar between patients with and those without DM, arrhythmia-free survival was significantly lower among patients with DM. Poor glycemic control seems to an important risk factor for AF recurrence.Item Open Access Catheter Ablation of Atrial Fibrillation in U.S. Community Practice--Results From Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF).(J Am Heart Assoc, 2015-05-21) Holmqvist, Fredrik; Simon, DaJuanicia; Steinberg, Benjamin A; Hong, Seok Jae; Kowey, Peter R; Reiffel, James A; Naccarelli, Gerald V; Chang, Paul; Gersh, Bernard J; Peterson, Eric D; Piccini, Jonathan P; ORBIT‐AF InvestigatorsBACKGROUND: The characteristics of patients undergoing atrial fibrillation (AF) ablation and subsequent outcomes in community practice are not well described. METHODS AND RESULTS: Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), we investigated the prevalence and impact of catheter ablation of AF. Among 9935 patients enrolled, 5.3% had previous AF ablation. Patients with AF ablation were significantly younger, more frequently male, and had less anemia, chronic obstructive pulmonary disease, and previous myocardial infarction (P<0.05 for all analyses) than those without previous catheter ablation of AF. Ablated patients were more likely to have a family history of AF, obstructive sleep apnea, paroxysmal AF, and moderate-to-severe symptoms (P<0.0001 for all analyses). Patients with previous ablation were more often in sinus rhythm on entry into the registry (52% vs. 32%; P<0.0001). Despite previous ablation, 46% in the ablation group were still on antiarrhythmic therapy. Oral anticoagulation was prescribed in 75% of those with previous ablation versus 76% in those without previous ablation (P=0.5). The adjusted risk of death (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.52 to 1.18; P=0.2) and cardiovascular (CV) hospitalization (HR, 1.06; 95% CI, 0.90 to 1.26; P=0.5) were similar in both groups. Patients with incident AF ablation had higher risk of subsequent CV hospitalization than matched patients without incident ablation (HR, 1.67; 95% CI, 1.24 to 2.26; P=0.0008). CONCLUSIONS: In U.S. clinical practice, a minority of patients with AF are managed with catheter ablation. Subsequent to ablation, there were no significant differences in oral anticoagulation use or outcomes, including stroke/non-central nervous system embolism/transient ischemic attack or death. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01165710.Item Open Access Clinical Characteristics, Oral Anticoagulation Patterns, and Outcomes of Medicaid Patients With Atrial Fibrillation: Insights From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF I) Registry.(J Am Heart Assoc, 2016-05-04) O'Brien, Emily C; Kim, Sunghee; Thomas, Laine; Fonarow, Gregg C; Kowey, Peter R; Mahaffey, Kenneth W; Gersh, Bernard J; Piccini, Jonathan P; Peterson, Eric DBACKGROUND: Whereas insurance status has been previously associated with care patterns, little is currently known about the association between Medicaid insurance and the clinical characteristics, treatment, or outcomes of patients with atrial fibrillation (AF). METHODS AND RESULTS: We used data from adults with AF enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF), a national outpatient registry conducted at 176 community, multispecialty sites. The primary outcome of interest was the proportion of patients prescribed any oral anticoagulation (OAC; warfarin or novel oral anticoagulants [NOAC]). Secondary outcomes of interest included the proportion of patients prescribed NOACs (dabigatran or rivaroxaban); time in therapeutic range (TTR) for warfarin users, all-cause mortality, stroke/systemic embolism, and major bleed. Of 10 133 patients, N=470 (4.6%) had Medicaid insurance. Medicaid patients were similarly likely to receive OAC at baseline (72.8% vs 76.3%; unadjusted P=0.079), but less likely to receive NOAC at baseline or follow-up (12.1% vs 16.3%; unadjusted P=0.019). After risk adjustment, Medicaid status was associated with lower use of OAC at baseline among patients with high stroke risk (odds ratio [OR]=0.68; 95% CI=0.49, 0.94), but was not associated with OAC use overall (OR=0.82; 95% CI=0.61, 1.09). Among warfarin users, median TTR was lower among Medicaid patients (60% vs 68%; P<0.0001; adjusted TTR difference, -2.9; 95% CI=-5.7, -0.2; P=0.04). Use of an NOAC over 2 years of follow-up was not statistically different by insurance. Compared with non-Medicaid patients, Medicaid patients had higher unadjusted rates of mortality, stroke/systemic embolism, and major bleeding; however, these differences were attenuated following adjustment for clinical characteristics. CONCLUSIONS: In a contemporary AF cohort, use of OAC overall and use of NOACs were not significantly lower among Medicaid patients relative to others. However, among warfarin users, Medicaid patients spent less time in therapeutic range compared with those with other forms of insurance.Item Open Access Correlation between AV synchrony and device collected AM-VP sequence counter in atrioventricular synchronous leadless pacemakers: A real-world assessment.(Journal of cardiovascular electrophysiology, 2023-01) Garweg, Christophe; Piccini, Jonathan P; Epstein, Laurence M; Frazier-Mills, Camille; Chinitz, Larry A; Steinwender, Clemens; Stromberg, Kurt; Sheldon, Todd; Fagan, Dedra H; El-Chami, Mikhael FIntroduction
Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV.Methods
The correlation between ECG-determined AVS in-clinic and device-collected %AM-VP was assessed using data from 40 patients with high-degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously-sampled %AM-VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included.Results
Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM-VP (median AVS 87.1%, median AM-VP 79.1%; R2 = 0.764, p < .001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM-VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years.Conclusion
In patients with a high pacing burden, %AM-VP provides a reasonable estimation of AVS. The first large real-world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM-VP, a correlate of AVS, of 74.7%.Item Open Access Diagnosis-to-ablation time predicts recurrent atrial fibrillation and rehospitalization following catheter ablation.(Heart rhythm O2, 2022-02) Chew, Derek S; Jones, Kelley A; Loring, Zak; Black-Maier, Eric; Noseworthy, Peter A; Exner, Derek V; Packer, Douglas L; Grant, Jennifer; Mark, Daniel B; Piccini, Jonathan PBackground
Wait times for catheter ablation in patients with symptomatic atrial fibrillation (AF) may influence clinical outcomes.Objective
This study examined the relationship between the duration from AF diagnosis to ablation, or diagnosis-to-ablation time (DAT), on the clinical response to catheter ablation in a large nationwide cohort of patients.Methods
We identified patients with new AF who underwent catheter ablation between January 2014 and December 2017 using the IBM MarketScan databases. Cox proportional hazard models were used to estimate the strength of the association between DAT and the outcomes of AF recurrence and hospitalization at 1 year postablation.Results
Among 11,143 AF patients who underwent ablation, the median age was 59 years, 31% were female, and the median CHA2DS2-VASc score was 2. Median DAT was 5.5 (2.6, 13.1) months. At 1 year postablation, 10.0% (n = 1116) developed recurrent AF. For each year increase in DAT, the risk of AF recurrence increased by 20% after adjustment for baseline comorbidities and medications (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.11-1.30). A longer DAT was associated with an increased risk of hospitalization (HR 1.08 per DAT year, 95% CI 1.02-1.15). DAT was a stronger predictor of AF recurrence postablation than traditional clinical risk factors, including age, prior heart failure, or renal failure.Conclusion
Increasing duration between AF diagnosis and catheter ablation is associated with higher AF recurrence rates and all-cause hospitalization. Our findings are consistent with a growing body of evidence supporting the benefits of prioritizing early restoration of sinus rhythm.Item Open Access Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation.(J Am Heart Assoc, 2013-11-25) Steinberg, Benjamin A; Holmes, Dajuanicia N; Piccini, Jonathan P; Ansell, Jack; Chang, Paul; Fonarow, Gregg C; Gersh, Bernard; Mahaffey, Kenneth W; Kowey, Peter R; Ezekowitz, Michael D; Singer, Daniel E; Thomas, Laine; Peterson, Eric D; Hylek, Elaine M; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and PatientsBACKGROUND: Dabigatran is a novel oral anticoagulant approved for thromboprophylaxis in atrial fibrillation. Adoption patterns of this new agent in community practice are unknown. METHODS AND RESULTS: We studied patterns of dabigatran use among patients enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry between June 2010 and August 2011 and followed for 12 months. Among 9974 atrial fibrillation patients included, 1217 (12%) were treated with dabigatran during the study. Overall, patients receiving dabigatran were younger (median age 72 versus 75 years, P<0.0001), more likely to be white (92% versus 89%, P=0.005), more likely to have private insurance (33% versus 25%, P<0.0001), and less likely to have prior cardiovascular disease (4% versus 33%, P<0.0001). They had more new-onset atrial fibrillation (8.8% versus 4.1%, P<0.0001), lower CHADS2 scores (estimated risk based on the presence of congestive heart failure, hypertension, aged ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack; mean 2.0 versus 2.3, P<0.0001), and lower Anticoagulation and Risk Factors in Atrial Fibrillation scores (mean 2.4 versus 2.8, P<0.0001). More than half (n=14/25, 56%) of patients with severe kidney disease were not prescribed reduced dosing, whereas 10% (n=91/920) with preserved renal function received lower dosing. Among patients not on dabigatran at baseline, 8% had dabigatran initiated during follow-up. Patient education was significantly associated with switching from warfarin to dabigatran (adjusted odds ratio for postgraduate 1.73, P=0.007), whereas antiarrhythmic drug use significantly correlated with de novo adoption of dabigatran (adjusted odds ratio 2.4, P<0.0001). CONCLUSIONS: Patients receiving dabigatran were younger and at a lower risk of stroke and bleeding. Patients appeared to drive switching from warfarin, whereas clinical characteristics influenced de novo start of dabigatran. These data suggest cautious early uptake of dabigatran, and more careful attention to dosing adjustments is warranted. CLINICAL TRIAL REGISTRATION URL: Clinicaltrials.gov. Unique identifier: NCT01165710.Item Open Access Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.(JAMA, 2019-04) Packer, Douglas L; Mark, Daniel B; Robb, Richard A; Monahan, Kristi H; Bahnson, Tristram D; Poole, Jeanne E; Noseworthy, Peter A; Rosenberg, Yves D; Jeffries, Neal; Mitchell, L Brent; Flaker, Greg C; Pokushalov, Evgeny; Romanov, Alexander; Bunch, T Jared; Noelker, Georg; Ardashev, Andrey; Revishvili, Amiran; Wilber, David J; Cappato, Riccardo; Kuck, Karl-Heinz; Hindricks, Gerhard; Davies, D Wyn; Kowey, Peter R; Naccarelli, Gerald V; Reiffel, James A; Piccini, Jonathan P; Silverstein, Adam P; Al-Khalidi, Hussein R; Lee, Kerry L; CABANA InvestigatorsImportance
Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain.Objective
To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF.Design, setting, and participants
The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017.Interventions
The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines.Main outcomes and measures
The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence.Results
Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P < .001).Conclusions and relevance
Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial.Trial registration
ClinicalTrials.gov Identifier: NCT00911508.Item Open Access Effectiveness of catheter ablation of atrial fibrillation according to heart failure etiology.(Journal of arrhythmia, 2020-02) Black-Maier, Eric; Steinberg, Benjamin A; Trulock, Kevin M; Wang, Frances; Lokhnygina, Yuliya; O'Neal, Wanda; Al-Khatib, Sana; Atwater, Brett D; Daubert, James P; Frazier-Mills, Camille; Hegland, Donald D; Jackson, Kevin P; Jackson, Larry R; Koontz, Jason I; Lewis, Robert K; Sun, Albert Y; Thomas, Kevin L; Bahnson, Tristram D; Piccini, Jonathan PBackground
Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs nonischemic heart failure.Methods
We conducted a retrospective, observational cohort study of patients with HF who underwent AF ablation. Outcomes were compared based on HF etiology and included in-hospital events, symptoms (Mayo AF Symptom Inventory [MAFSI]), and functional status (New York Heart Association class) and freedom from atrial arrhythmias at 12 months.Results
Among 242 patients (n = 70 [29%] ischemic, n = 172 [71%] nonischemic), patients with nonischemic cardiomyopathy were younger (mean age 64 ± 11.5 vs 69 ± 9.1, P = .002), more often female (36% vs 17%, P = .004), and had higher mean left-ventricular ejection fraction (47% vs 42%, P = .0007). There were no significant differences in periprocedural characteristics, including mean procedure time (243 ± 74.2 vs 259 ± 81.8 minutes, P = .1) and nonleft atrial ablation (17% vs 20%, P = .6). All-cause adverse events were similar in each group (15% vs 17%, P = .7). NYHA and MAFSI scores improved significantly at follow-up and did not differ according to HF etiology (P = .5; P = .10-1.00 after Bonferroni correction). There were no significant differences in freedom from recurrent atrial arrhythmia at 12-months between ischemic (74%) and nonischemic patients (78%): adjusted RR 0.63, 95% confidence interval 0.33-1.19.Conclusions
Catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic vs nonischemic HF etiology.Item Open Access Heart rate is associated with progression of atrial fibrillation, independent of rhythm.(Heart, 2015-06) Holmqvist, Fredrik; Kim, Sunghee; Steinberg, Benjamin A; Reiffel, James A; Mahaffey, Kenneth W; Gersh, Bernard J; Fonarow, Gregg C; Naccarelli, Gerald V; Chang, Paul; Freeman, James V; Kowey, Peter R; Thomas, Laine; Peterson, Eric D; Piccini, Jonathan P; ORBIT-AF InvestigatorsOBJECTIVE: Atrial fibrillation (AF) often progresses from paroxysmal or persistent to more sustained forms, but the rate and predictors of AF progression in clinical practice are not well described. METHODS: Using the Outcomes Registry for Better Informed Treatment of AF, we analysed the incidence and predictors of progression and tested the discrimination and calibration of the HATCH (hypertension, age, TIA/stroke, chronic obstructive pulmonary disease, heart failure) and CHA₂DS₂VASc scores for identifying AF progression. RESULTS: Among 6235 patients with paroxysmal or persistent AF at baseline, 1479 progressed, during follow-up (median 18 (IQR 12-24) months). These patients were older and had more comorbidities than patients who did not progress (CHADS₂ 2.3±1.3 vs 2.1±1.3, p<0.0001). At baseline, patients with AF progression were more often on a rate control as opposed to a rhythm control strategy (66 vs 56%, p<0.0001) and had higher heart rate (72(64-80) vs 68(60-76) bpm, p<0.0001). The strongest predictors of AF progression were AF on the baseline ECG (OR 2.30, 95% CI 1.95 to 2.73, p<0.0001) and increasing age (OR 1.16, 95% CI1.09 to 1.24, p<0.0001, per 10 increase), while patients with lower heart rate (OR 0.84, 95% CI 0.79 to 0.89, p<0.0001, per 10 decrease ≤80) were less likely to progress. There was no significant interaction between rhythm on baseline ECG and heart rate (p=0.71). The HATCH and CHA₂DS₂VASc scores had modest discriminatory power for AF progression (C-indices 0.55 (95% CI 0.53 to 0.58) and 0.55 (95% CI 0.52 to 0.57)). CONCLUSIONS: Within 1.5 years, almost a quarter of the patients with paroxysmal or persistent AF progress to a more sustained form. Progression is strongly associated with heart rate, and age.Item Open Access Implications for Neuromodulation Therapy to Control Inflammation and Related Organ Dysfunction in COVID-19(Journal of Cardiovascular Translational Research) Fudim, Marat; Qadri, Yawar J; Ghadimi, Kamrouz; MacLeod, David B; Molinger, Jeroen; Piccini, Jonathan P; Whittle, John; Wischmeyer, Paul E; Patel, Manesh R; Ulloa, LuisItem Open Access Increased Heart Rate Is Associated With Higher Mortality in Patients With Atrial Fibrillation (AF): Results From the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF).(J Am Heart Assoc, 2015-09-14) Steinberg, Benjamin A; Kim, Sunghee; Thomas, Laine; Fonarow, Gregg C; Gersh, Bernard J; Holmqvist, Fredrik; Hylek, Elaine; Kowey, Peter R; Mahaffey, Kenneth W; Naccarelli, Gerald; Reiffel, James A; Chang, Paul; Peterson, Eric D; Piccini, Jonathan P; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT‐AF) Investigators and PatientsBACKGROUND: Most patients with atrial fibrillation (AF) require rate control; however, the optimal target heart rate remains under debate. We aimed to assess rate control and subsequent outcomes among patients with permanent AF. METHODS AND RESULTS: We studied 2812 US outpatients with permanent AF in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Resting heart rate was measured longitudinally and used as a time-dependent covariate in multivariable Cox models of all-cause and cause-specific mortality during a median follow-up of 24 months. At baseline, 7.4% (n=207) had resting heart rate <60 beats per minute (bpm), 62% (n=1755) 60 to 79 bpm, 29% (n=817) 80 to 109 bpm, and 1.2% (n=33) ≥110 bpm. Groups did not differ by age, previous cerebrovascular disease, heart failure status, CHA2DS2-VASc scores, renal function, or left ventricular function. There were significant differences in race (P=0.001), sinus node dysfunction (P=0.004), and treatment with calcium-channel blockers (P=0.006) and anticoagulation (P=0.009). In analyses of continuous heart rates, lower heart rate ≤65 bpm was associated with higher all-cause mortality (adjusted hazard ratio [HR], 1.15 per 5-bpm decrease; 95% CI, 1.01 to 1.32; P=0.04). Similarly, increasing heart rate >65 bpm was associated with higher all-cause mortality (adjusted HR, 1.10 per 5-bpm increase; 95% CI, 1.05 to 1.15; P<0.0001). This relationship was consistent across endpoints and in a broader sensitivity analysis of permanent and nonpermanent AF patients. CONCLUSIONS: Among patients with permanent AF, there is a J-shaped relationship between heart rate and mortality. These data support current guideline recommendations, and clinical trials are warranted to determine optimal rate control. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/. Unique identifier: NCT01165710.Item Open Access Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis.(Annals of internal medicine, 2022-08) Chew, Derek S; Zhou, Ke; Pokorney, Sean D; Matchar, David B; Vemulapalli, Sreekanth; Allen, Larry A; Jackson, Kevin P; Samad, Zainab; Patel, Manesh R; Freeman, James V; Piccini, Jonathan PBackground
Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation.Objective
To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding.Design
Decision analysis with a Markov model.Data sources
Evidence from the published literature informed model inputs.Target population
Women and men with nonvalvular AF and without prior stroke.Time horizon
Lifetime.Perspective
Clinical.Intervention
LAAO versus warfarin or direct oral anticoagulants (DOACs).Outcome measures
The primary end point was clinical benefit measured in quality-adjusted life-years.Results of base-case analysis
The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA2DS2-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA2DS2-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs.Results of sensitivity analysis
Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data.Limitation
Clinical effectiveness data were drawn primarily from studies on the Watchman device.Conclusion
Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO.Primary funding source
None.Item Open Access Management and outcomes of patients with atrial fibrillation and a history of cancer: the ORBIT-AF registry.(Eur Heart J Qual Care Clin Outcomes, 2017-07-01) Melloni, Chiara; Shrader, Peter; Carver, Joseph; Piccini, Jonathan P; Thomas, Laine; Fonarow, Gregg C; Ansell, Jack; Gersh, Bernard; Go, Alan S; Hylek, Elaine; Herling, Irving M; Mahaffey, Kenneth W; Yu, Anthony F; Peterson, Eric D; Kowey, Peter R; ORBIT-AF Steering CommitteeAims: The presence of cancer can complicate treatment choices for patients with atrial fibrillation (AF) increasing both the risk of thrombotic and bleeding events. Methods and results: Using data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, we aimed to characterize AF patients with cancer, to describe their management and to assess the association between cancer and cardiovascular (CV) outcomes. Among 9749 patients, 23.8% had history of cancer (57% solid malignancy, 1.3% leukaemia, 3.3% lymphoma, 40% other type, and 2.2% metastatic cancer). Patients with history of cancer were older, more likely to have CV disease, CV risk factors, and prior gastrointestinal bleeding. No difference in antiarrhythmic and antithrombotic therapy was observed between those with and without cancer. Patients with history of cancer had a significantly higher risk of death (7.8 vs. 4.9 deaths per 100 patient-years follow-up, P = 0.0003) mainly driven by non-CV death (4.2 vs. 2.4 per 100 patient-years follow-up; P = 0.0004) and higher risk of major bleeding (5.1 vs. 3.5 per 100 patient-years follow-up; P = 0.02) compared with non-cancer patients; no differences were observed in risks of strokes/non-central nervous system embolism (1.96 vs. 1.48, P = 0.74) and CV death (2.89 vs. 2.07, P = 0.35) between the two groups. Conclusion: A history of cancer is common among AF patients with up to one in four patients having both. Antithrombotic therapy, rates of cerebrovascular accident, other thrombotic events and cardiac death were similar in AF patients with or without a history of cancer. Patients with cancer, however, were at higher risk of major bleeding and non-CV death.Item Open Access Management of Atrial Fibrillation in Older Patients by Morbidity Burden: Insights From Get With The Guidelines-Atrial Fibrillation.(Journal of the American Heart Association, 2020-12) Dalgaard, Frederik; Xu, Haolin; Matsouaka, Roland A; Russo, Andrea M; Curtis, Anne B; Rasmussen, Peter Vibe; Ruwald, Martin H; Fonarow, Gregg C; Lowenstern, Angela; Hansen, Morten L; Pallisgaard, Jannik L; Alexander, Karen P; Alexander, John H; Lopes, Renato D; Granger, Christopher B; Lewis, William R; Piccini, Jonathan P; Al-Khatib, Sana MBackground Knowledge is scarce regarding how multimorbidity is associated with therapeutic decisions regarding oral anticoagulants (OACs) in patients with atrial fibrillation. Methods and Results We conducted a cross-sectional study of hospitalized patients with atrial fibrillation using the Get With The Guidelines-Atrial Fibrillation registry from 2013 to 2019. We identified patients ≥65 years and eligible for OAC therapy. Using 16 available comorbidity categories, patients were stratified by morbidity burden. A multivariable logistic regression model was used to determine the odds of receiving OAC prescription at discharge by morbidity burden. We included 34 174 patients with a median (interquartile range) age of 76 (71-83) years, 56.6% women, and 41.9% were not anticoagulated at admission. Of these patients, 38.6% had 0 to 2 comorbidities, 50.7% had 3 to 5 comorbidities, and 10.7% had ≥6 comorbidities. The overall discharge OAC prescription was high (85.6%). The prevalence of patients with multimorbidity increased from 59.7% in 2014 to 64.3% in 2019 (P trend=0.002). Using 0 to 2 comorbidities as the reference, the adjusted odds ratio (95% CI) of OAC prescription were 0.93 (0.82, 1.05) for patients with 3 to 5 comorbidities and 0.72 (0.60, 0.86) for patients with ≥6 comorbidities. In those with ≥6 comorbidities, the most common reason for nonprescription of OACs were frequent falls/frailty (31.0%). Conclusions In a contemporary quality-of-care database of hospitalized patients with atrial fibrillation eligible for OAC therapy, multimorbidity was common. A higher morbidity burden was associated with a lower odds of OAC prescription. This highlights the need for interventions to improve adherence to guideline-recommended anticoagulation in multimorbid patients with atrial fibrillation.Item Open Access Noninvasive electrocardiographic mapping of ventricular tachycardia in a patient with a left ventricular assist device.(HeartRhythm case reports, 2020-07) Rehorn, Michael R; Koontz, Jason; Barnett, Adam S; Black-Maier, Eric; Piccini, Jonathan P; Loring, Zak; Schroder, Jacob; Sun, Albert YItem Open Access Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis.(Journal of cardiovascular electrophysiology, 2015-02) Pokorney, Sean D; Zhou, Ke; Matchar, David B; Love, Sean; Zeitler, Emily P; Lewis, Robert; Piccini, Jonathan PIntroduction
Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.Methods and results
A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%).Conclusions
Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.Item Open Access Optimizing mechanically sensed atrial tracking in patients with atrioventricular-synchronous leadless pacemakers: A single-center experience.(Heart rhythm O2, 2021-10) Arps, Kelly; Piccini, Jonathan P; Yapejian, Rebecca; Leguire, Rhonda; Smith, Brenda; Al-Khatib, Sana M; Bahnson, Tristram D; Daubert, James P; Hegland, Donald D; Jackson, Kevin P; Jackson, Larry R; Lewis, Robert K; Pokorney, Sean D; Sun, Albert Y; Thomas, Kevin L; Frazier-Mills, CamilleBackground
Atrioventricular (AV)-synchronous single-chamber leadless pacing using a mechanical atrial sensing algorithm produced high AV synchrony in clinical trials, but clinical practice experience with these devices has not yet been described.Objective
To describe pacing outcomes and programming changes with AV-synchronous leadless pacemakers in clinical practice.Methods
Consecutive patients without persistent atrial fibrillation who received an AV-synchronous leadless pacemaker and completed follow-up between February 2020 and April 2021 were included. We evaluated tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP), total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch), use of programming optimization, and improvement in AV synchrony after optimization.Results
Fifty patients met the inclusion criteria. Mean age was 69 ± 16.8 years, 24 (48%) were women, 24 (48%) had complete heart block, and 17 (34%) required ≥50% pacing. Mean tracking index was 41% ± 34%. Thirty-five patients (70%) received ≥1 programming change. In 36 patients with 2 follow-up visits, tracking improved by +9% ± 28% (P value for improvement = .09) and +18% ± 19% (P = .02) among 15 patients with complete heart block. Average total AV synchrony increased from 89% [67%, 99%] to 93% [78%, 100%] in all patients (P = .22), from 86% [52%, 98%] to 97% [82%, 99%] in those with complete heart block (P = .04), and from 73% [52%, 80%] to 78% [70%, 85%] in those with ≥50% pacing (P = .09).Conclusion
In patients with AV-synchronous leadless pacemakers, programming changes are frequent and are associated with increased atrial tracking and increased AV synchrony in patients with complete heart block.Item Open Access Outcomes Associated With Familial Versus Nonfamilial Atrial Fibrillation: A Matched Nationwide Cohort Study.(J Am Heart Assoc, 2016-11-19) Gundlund, Anna; Olesen, Jonas Bjerring; Staerk, Laila; Lee, Christina; Piccini, Jonathan P; Peterson, Eric D; Køber, Lars; Torp-Pedersen, Christian; Gislason, Gunnar H; Fosbøl, Emil LoldrupBACKGROUND: We examined all-cause mortality and long-term thromboembolic risk (ischemic stroke, transient ischemic attack, systemic thromboembolism) in patients with and without familial atrial fibrillation (AF). METHODS AND RESULTS: Using Danish nationwide registry data, we identified all patients diagnosed with AF (1995-2012) and divided them into those with familial AF (having a first-degree family member with a prior AF admission) and those with nonfamilial AF. We paired those with and without familial AF according to age, year of AF diagnosis, and sex in a 1:1 match. Using cumulative incidence and multivariable Cox models, we examined the risk of long-term outcomes. We identified 8658 AF patients (4329 matched pairs) with and without familial AF. The median age was 50 years (interquartile range 43-54 years), and 21.4% were women. Compared with nonfamilial AF patients, those with familial AF had slightly less comorbid illness but similar overall CHA2DS2-VASc score (P=0.155). Median follow-up was 3.4 years (interquartile range 1.5-6.5 years). Patients with familial AF had risk of death and thromboembolism similar to those with nonfamilial AF (adjusted hazard ratio 0.91 [95% CI 0.79-1.04] for death and 0.90 [95% CI 0.71-1.14] for thromboembolism). CONCLUSIONS: Although family history of AF is associated with increased likelihood for development of AF, once AF developed, long-term risks of death and thromboembolic complications were similar in familial and nonfamilial AF patients.