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Shared decision-making (SDM) and multidisciplinary team-based care delivery are recommended across several cardiology clinical practice guidelines. However, evidence for benefit and guidance on implementation are limited. Informed consent, the use of patient decision aids, or the documentation of these elements for governmental or societal agencies may be conflated as SDM. SDM is a bidirectional exchange between experts: patients are the experts on their goals, values, and preferences, and clinicians provide their expertise on clinical factors. In this Expert Panel perspective, we review the current state of SDM in team-based cardiovascular care and propose best practice recommendations for multidisciplinary team implementation of SDM.
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Importance: Osteosarcopenia is an emerging geriatric syndrome characterized by age-related deterioration in muscle and bone. Despite the established relevance of frailty and sarcopenia among older adults undergoing transcatheter aortic valve replacement (TAVR), osteosarcopenia has yet to be investigated in this setting. Objective: To determine the association between osteosarcopenia and adverse outcomes following TAVR. Design, Setting, and Participants: This is a post hoc analysis of the Frailty in Aortic Valve Replacement (FRAILTY-AVR) prospective multicenter cohort study and McGill extension that enrolled patients aged 70 years or older undergoing TAVR from 2012 through 2022. FRAILTY-AVR was conducted at 14 centers in Canada, the United States, and France between 2012 and 2016, and patients at the McGill University-affiliated center in Montreal, Québec, Canada, were enrolled on an ongoing basis up to 2022. Exposure: Osteosarcopenia as measured on computed tomography (CT) scans prior to TAVR. Main Outcomes and Measures: Clinically indicated CT scans acquired prior to TAVR were analyzed to quantify psoas muscle area (PMA) and vertebral bone density (VBD). Osteosarcopenia was defined as a combination of low PMA and low VBD according to published cutoffs. The primary outcome was 1-year all-cause mortality. Secondary outcomes were 30-day mortality, hospital length of stay, disposition, and worsening disability. Multivariable logistic regression was used to adjust for potential confounders. Results: Of the 605 patients (271 [45%] female) in this study, 437 (72%) were octogenarian; the mean (SD) age was 82.6 (6.2) years. Mean (SD) PMA was 22.1 (4.5) cm2 in men and 15.4 (3.5) cm2 in women. Mean (SD) VBD was 104.8 (35.5) Hounsfield units (HU) in men and 98.8 (34.1) HU in women. Ninety-one patients (15%) met the criteria for osteosarcopenia and had higher rates of frailty, fractures, and malnutrition at baseline. One-year mortality was highest in patients with osteosarcopenia (29 patients [32%]) followed by those with low PMA alone (18 patients [14%]), low VBD alone (16 patients [11%]), and normal bone and muscle status (21 patients [9%]) (P < .001). Osteosarcopenia, but not low VBD or PMA alone, was independently associated with 1-year mortality (odds ratio [OR], 3.18; 95% CI, 1.54-6.57) and 1-year worsening disability (OR, 2.11; 95% CI, 1.19-3.74). The association persisted in sensitivity analyses adjusting for the Essential Frailty Toolset, Clinical Frailty Scale, and geriatric conditions such as malnutrition and disability. Conclusions and Relevance: The findings suggest that osteosarcopenia detected using clinical CT scans could be used to identify frail patients with a 3-fold increase in 1-year mortality following TAVR. This opportunistic method for osteosarcopenia assessment could be used to improve risk prediction, support decision-making, and trigger rehabilitation interventions in older adults.
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Estenose da Valva Aórtica , Sarcopenia , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Sarcopenia/epidemiologia , Sarcopenia/complicações , Idoso de 80 Anos ou mais , Idoso , Estudos Prospectivos , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Fragilidade/complicações , Tomografia Computadorizada por Raios X , Densidade Óssea , Músculos Psoas/diagnóstico por imagem , Canadá/epidemiologia , França/epidemiologia , Idoso Fragilizado , Fatores de RiscoRESUMO
BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60â min; P < .001) and intervention times (85 vs. 95â min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
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Estenose da Valva Aórtica , Benchmarking , Tempo de Internação , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Masculino , Feminino , Idoso de 80 Anos ou mais , Tempo de Internação/estatística & dados numéricos , Idoso , Procedimentos Clínicos , Europa (Continente)/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Segurança do PacienteRESUMO
AIMS: Early mobilization is associated with improved outcomes in hospitalized older patients. We sought to determine the effect of a nurse-led protocol on mobilization 4 h after transfemoral transcatheter aortic valve implantation (TAVI) across different units of care. METHODS AND RESULTS: We conducted a prospective observational cohort single-centre study of consecutive patients. We implemented a standardized protocol for safe early recovery and progressive mobilization in the critical care and cardiac telemetry units. We measured the time to first mobilization and conducted descriptive statistics to identify patient and system barriers to timely ambulation. We recruited 139 patients (82.5 years, SD = 6.7; 46% women). At baseline, patients who were mobilized early (≤4 h) and late (>4 h) did not differ, except for higher rates of diabetes (25.5% vs. 43.9%, P = 0.032) and peripheral arterial disease (8.2% vs. 26.8%, P = 0.003) in the late mobilization group. The median time to mobilization was 4 h [inter-quartile range (IQR) 3.25, 4]; 98 patients (70.5%) were mobilized successfully after 4 h of bedrest; 118 (84.9%) were walking by the evening of the procedure (<8 h bedrest); and 21 (15.1%) were on bedrest overnight and mobilized the following day. Primary reasons for overnight bedrest were arrhythmia monitoring (n = 10, 7.2%) and haemodynamic and/or neurological instability (n = 6, 4.3%); six patients (4.3%) experienced delayed ambulation due to system issues. Procedure location in the hybrid operating room and transfer to critical care were associated with longer bedrest times. CONCLUSION: Standardized nurse-led mobilization 4 h after TF TAVI is feasible in the absence of clinical complications and system barriers.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Masculino , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Deambulação Precoce , Resultado do Tratamento , Fatores de Tempo , Estudos de CoortesRESUMO
Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.
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Estenose da Valva Aórtica , Fragilidade , Substituição da Valva Aórtica Transcateter , Idoso , Feminino , Humanos , Masculino , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Fragilidade/complicações , Fragilidade/prevenção & controle , Qualidade de Vida , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
The 12-item version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) was originally developed for patients with heart failure but has been used and tested among patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation. Whether the instrument is suitable for patients with AS who underwent surgical aortic valve replacement (SAVR) is currently unknown. Thus, we aimed to investigate the psychometric properties of the KCCQ-12 before and after SAVR among patients with severe AS. We conducted a prospective cohort of 184 patients with AS who completed the KCCQ-12 and the EuroQol 5 Dimension 5 Levels before and 4 weeks after surgery. Construct validity was investigated with hypothesis testing and an analysis of Spearman's correlation between the two instruments. Structural validity was investigated with explorative and confirmatory factor analyses and reliability with Cronbach's α. All analyses were conducted on data from the two time points (preoperatively and four weeks after surgery). The hypothesis testing revealed how the New York Heart Association class was significantly correlated with the preoperative KCCQ-12 total score (higher New York Heart Association class, worse score). A longer length of hospital stay and living alone were significantly associated with poorer postoperative KCCQ-12 total score. KCCQ-12 and EuroQol 5 Dimension 5 Levels were moderately correlated in most domains/the total score/Visual Analogue Scale score. Principal component analyses revealed two 3-factor structures. The confirmatory factor analyses did not support the original model at any time point. Cronbach's α ranged from 0.22 to 0.84 in three preoperative factors and from 0.39 to 0.76 in the postoperative factors. The total Cronbach's α was 0.83 for the suggested preoperative 3-factor model and 0.83 for the postoperative model. In conclusion, the Danish version of the KCCQ-12 tested in a population of patients with AS who underwent SAVR appears to have acceptable construct validity, whereas structural validity cannot be confirmed for the original four-factor model. Overall reliability is good.
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Estenose da Valva Aórtica , Cardiomiopatias , Substituição da Valva Aórtica Transcateter , Humanos , Nível de Saúde , Qualidade de Vida , Estudos Prospectivos , Kansas , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Cardiomiopatias/cirurgia , Resultado do TratamentoRESUMO
Knowledge translation (KT) is the exchange between knowledge producers and users to understand, synthesize, share, and apply evidence to accelerate the benefits of research to improve health and health systems. Knowledge translation practice (activities/strategies to move evidence into practice) and KT science (study of the methodology and approaches to promote the uptake of research) benefit from the use of conceptual thinking, the meaningful inclusion of patients, and the application of intersectionality. In spite of multiple barriers, there are opportunities to develop strong partnerships and evidence to drive an impactful research agenda and increase the uptake of cardiovascular research.
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Serviços de Saúde , Ciência Translacional Biomédica , HumanosRESUMO
Background: Historically, quality-of-care monitoring was performed separately for transcatheter and surgical aortic valve replacement (TAVR, SAVR). Using consensus indicators, we provide a global report on the quality of care for treatment of aortic stenosis across the highest-volume treatments: transfemoral (TF) TAVR, isolated SAVR, and SAVR combined with coronary artery bypass graft. Methods: Retrospective observational cohort study of consecutive patients in a regional system of care. Primary endpoint was 30-day and 1-year mortality (2015-2019). Secondary endpoints included rate of new pacemaker, rate of readmission, and length of stay (2012-2019). Following multivariable logistic regressions, we developed mortality case-mix adjustment models to report risk estimates. Results: The proportion of patients receiving TAVR grew from 32% to 53% (2015-2019). Those receiving TF TAVR were significantly older, with higher rates of comorbidities. Observed 30-day and 1-year all-cause mortality after TF TAVR decreased from 3.1% to 0.6% (P = 0.03), and 13.6% to 6.6% (P = 0.09), respectively; surgical mortality rates for isolated SAVR and SAVR combined with coronary artery bypass graft were low and did not change significantly over time, ranging from 0.3% to 1.4% and from 0.9% to 3.4%, respectively at 30 days, and from 0.9% to 3.4% and from 4.7% to 6.7 at 1 year. In the TF TAVR cohort, the observed vs expected ratio for 30-day and 1-year mortality decreased significantly from 1.9 (95% confidence interval [CI] 0.9, 3.5) to 0.3 (95% CI 0.1, 0.8), and from 1.3 (95% CI 0.9, 1.7) to 0.7 (95% CI 0.5, 0.99), respectively; no change occurred in risk-adjusted surgical mortality. Conclusions: Consensus quality indicators provide unique insights on the quality of care for patients receiving treatment for aortic stenosis.
Contexte: Par le passé, la surveillance de la qualité des soins était réalisée séparément pour l'implantation valvulaire aortique par cathéter (IVAC) et la chirurgie de remplacement valvulaire aortique (CRVA). À l'aide d'indicateurs consensuels, nous dressons un rapport général de la qualité des soins dans les traitements les plus courants de la sténose aortique : IVAC fémorale, CRVA seule et CRVA combinée à un pontage coronarien. Méthodologie: Une étude de cohorte observationnelle et rétrospective a été menée pour évaluer les patients consécutifs ayant fréquenté un système de santé régional. Le critère d'évaluation principal était le taux de mortalité à 30 jours et à 1 an (2015 à 2019). Les critères d'évaluation secondaires comprenaient le taux de nouveaux sti-mulateurs cardiaques, le taux de réadmission et la durée du séjour (2012 à 2019). Après des régressions logistiques multivariées, nous avons élaboré des modèles d'ajustement selon les groupes de cas pour le taux de mortalité afin d'estimer les risques. Résultats: La proportion de patients qui ont subi une IVAC est passée de 32 % à 53 % (2015 à 2019). Les patients qui ont subi une IVAC transfémorale étaient significativement plus vieux que ceux des autres groupes et présentaient un plus haut taux d'affections concomitantes. Les taux de mortalité de toute cause observés à 30 jours et à 1 an après une IVAC transfémorale ont respectivement diminué de 3,1 % à 0,6 % (P = 0,03) et de 13,6 % à 6,6 % (P = 0,09). Les taux de mortalité pour une CRVA seule et une CRVA combinée à un pontage coronarien étaient faibles et n'ont pas changé de manière significative au fil du temps : les taux de mortalité à 30 jours sont passés de 0,3 % à 1,4 % et de 0,9 % à 3,4 %, respectivement, et les taux de mortalité à 1 an, de 0,9 % à 3,4 % et de 4,7 % à 6,7 %, respectivement. Dans la cohorte ayant subi une IVAC transfémorale, le rapport du taux de mortalité observé par rapport au taux de mortalité attendu à 30 jours et à 1 an a diminué de manière significative, soit de 1,9 (intervalle de confiance [IC] à 95 % : 0,9 à 3,5) à 0,3 (IC à 95 % : 0,1 à 0,8), et de 1,3 (IC à 95 % : 0,9 à 1,7) à 0,7 (IC à 95 % : 0,5 à 0,99), respectivement. Aucune variation n'a été notée quant au taux de mortalité ajusté selon les risques pour une intervention chirurgicale. Conclusions: Les indicateurs consensuels de la qualité fournissent des informations uniques sur la qualité des soins chez les patients traités pour une sténose aortique.
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BACKGROUND: Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. METHODS: This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. RESULTS: Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59-16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82-9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40-11.09; all p < 0.001, respectively) were confirmed as significant factors. CONCLUSIONS: While non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.
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Estenose da Valva Aórtica , Fibrilação Atrial , Fragilidade , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Idoso , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Idoso Fragilizado , Universidades , Bloqueio de Ramo/etiologia , Fibrilação Atrial/etiologia , Resultado do Tratamento , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Fatores de Risco , Próteses Valvulares Cardíacas/efeitos adversosRESUMO
Background: The role of multidisciplinary clinics for psychosocial care is increasingly recognized for those living with inherited cardiac conditions (ICC). In Canada, access to healthcare providers differ between clinics. Little is known about the relationship between access to specialty care and a patient's ability to cope with, and manage their condition. Methods: We leveraged the Hearts in Rhythm Organization (HiRO) to conduct a cross-sectional, community-based survey of individuals with ICC and their family members. We aimed to describe access to services, and explore the relationships between participants' characteristics, cardiac history and self-reported health status and self-efficacy (GSE: General Self-Efficacy Scale) and empowerment (GCOS-24: Genetic Counseling Outcome Scale). Results: We collected 235 responses from Canadian participants in 10 provinces and territories. Overall, 63% of participants reported involvement of a genetic counsellor in their care. Access to genetic testing was associated with greater empowerment [mean GCOS-24: 121.14 (SD = 20.53) vs. 105.68 (SD = 21.69); p = 0.004]. Uncertain genetic test results were associated with lower perceived self-efficacy (mean GSE: uncertain = 28.85 vs. positive = 33.16, negative = 34.13; p = 0.01). Low global mental health scores correlated with both lower perceived self-efficacy and empowerment scores, with only 11% of affected participants reporting involvement of psychology services in their care. Conclusion: Differences in resource accessibility, clinical history and self-reported health status impact the perceived self-efficacy and empowerment of patients with ICC. Future research evaluating interventions to improve patient outcomes is recommended.
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AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) is a minimally invasive treatment option for patients with severe symptomatic mitral regurgitation who are at increased risk for cardiac surgery and are receiving optimal medical therapy. Little is known about patients' perspectives on their journey of care, including their experiences leading up to treatment and their early recovery period. The aim of this study was to explore patients' experiences of their journey to TEER and their perspectives on early recovery. METHODS AND RESULTS: We conducted a qualitative study using interpretive description. A purposive sample of 12 patients from a purposive sample, 3-6 monthspost-TEER procedure, were recruited from a tertiary hospital. The median age of the patients was 79 years, with seven males and five females. Data collection included semi-structured interviews over the phone. Data analysis followed an iterative process and utilized thematic analysis. There were four central themes highlighting the experiences of the patients leading up to their procedure: (i) escalating challenges with everyday life; (ii) plummeting losses; (iii) choosing and readiness to proceed with TEER; and (iv) the long and uncertain waiting time. The theme-improved health status highlights the experiences of patients in their early recovery. CONCLUSION: Patients' experiences of waiting for TEER are complex and involve multifaceted challenges related to their worsening cardiac symptoms and navigating the healthcare system. Therefore, care pathways must be put in place to provide continuity of care and support.
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Análise de Dados , Implante de Prótese de Valva Cardíaca , Feminino , Masculino , Humanos , Idoso , Coleta de Dados , Nível de Saúde , Pacientes , Avaliação de Resultados da Assistência ao Paciente , Resultado do Tratamento , Cateterismo CardíacoRESUMO
BACKGROUND: Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation. METHODS: We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected. RESULTS: A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group. CONCLUSIONS: Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).