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1.
Eur Heart J ; 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38923509

ABSTRACT

Cardiac sarcoidosis (CS) is a form of inflammatory cardiomyopathy associated with significant clinical complications such as high-degree atrioventricular block, ventricular tachycardia, and heart failure as well as sudden cardiac death. It is therefore important to provide an expert consensus statement summarizing the role of different available diagnostic tools and emphasizing the importance of a multidisciplinary approach. By integrating clinical information and the results of diagnostic tests, an accurate, validated, and timely diagnosis can be made, while alternative diagnoses can be reasonably excluded. This clinical expert consensus statement reviews the evidence on the management of different CS manifestations and provides advice to practicing clinicians in the field on the role of immunosuppression and the treatment of cardiac complications based on limited published data and the experience of international CS experts. The monitoring and risk stratification of patients with CS is also covered, while controversies and future research needs are explored.

2.
JACC Clin Electrophysiol ; 10(6): 1178-1190, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38727660

ABSTRACT

BACKGROUND: Desmin (DES) pathogenic variants cause a small proportion of arrhythmogenic cardiomyopathy (ACM). Outcomes data on DES-related ACM are scarce. OBJECTIVES: This study sought to provide information on the clinical phenotype and outcomes of patients with ACM caused by pathogenic variants of the DES gene in a multicenter cohort. METHODS: We collected phenotypic and outcomes data from 16 families with DES-related ACM from 10 European centers. We assessed in vitro DES aggregates. Major cardiac events were compared to historical controls with lamin A/C truncating variant (LMNA-tv) and filament C truncating variant (FLNC-tv) ACM. RESULTS: Of 82 patients (54% males, median age: 36 years), 11 experienced sudden cardiac death (SCD) (n = 7) or heart failure death (HFd)/heart transplantation (HTx) (n = 4) before clinical evaluation. Among 68 survivors, 59 (86%) presented signs of cardiomyopathy, with left ventricular (LV) dominant (50%) or biventricular (34%) disease. Mean LV ejection fraction was 51% ± 13%; 36 of 53 had late gadolinium enhancement (ring-like pattern in 49%). During a median of 6.73 years (Q1-Q3: 3.55-9.52 years), the composite endpoint (sustained ventricular tachycardia, aborted SCD, implantable cardioverter-defibrillator therapy, SCD, HFd, and HTx) was achieved in 15 additional patients with HFd/HTx (n = 5) and SCD/aborted SCD/implantable cardioverter-defibrillator therapy/sustained ventricular tachycardia (n = 10). Male sex (P = 0.004), nonsustained ventricular tachycardia (P = 0.017) and LV ejection fraction ≤50% (P = 0.012) were associated with the composite endpoint. Males with DES variants had similar outcomes to historical FLNC-tv and LMNA-tv controls. However, females showed better outcomes than those with LMNA-tv. In vitro experiments showed the characteristic finding of DES aggregates in 7 of 12 variants. CONCLUSIONS: DES ACM is associated with poor outcomes which can be predicted with potentially successful treatments, underscoring the importance of familial evaluation and genetic studies to identify at risk individuals.


Subject(s)
Arrhythmogenic Right Ventricular Dysplasia , Death, Sudden, Cardiac , Desmin , Phenotype , Humans , Male , Female , Adult , Middle Aged , Death, Sudden, Cardiac/etiology , Desmin/genetics , Arrhythmogenic Right Ventricular Dysplasia/genetics , Arrhythmogenic Right Ventricular Dysplasia/physiopathology , Young Adult , Defibrillators, Implantable , Heart Transplantation , Adolescent
3.
Europace ; 25(10)2023 10 05.
Article in English | MEDLINE | ID: mdl-37789664

ABSTRACT

AIMS: Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era. METHODS AND RESULTS: An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures. CONCLUSION: There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS.


Subject(s)
Atrial Fibrillation , COVID-19 , Cardiac Resynchronization Therapy , Defibrillators, Implantable , Humans , Cardiac Resynchronization Therapy/methods , Length of Stay , COVID-19/epidemiology , Surveys and Questionnaires
4.
Pacing Clin Electrophysiol ; 46(11): 1315-1324, 2023 11.
Article in English | MEDLINE | ID: mdl-37812167

ABSTRACT

BACKGROUND: Novel pacing technologies, such as His bundle pacing (HBP) and left bundle branch area pacing (LBBaP), have emerged to maintain physiological ventricular activation. We investigated the outcomes of LBBP with HBP for patients requiring a de novo permanent pacing. METHODS AND RESULTS: Systematic review of randomized clinical trials and observational studies comparing LBBaP with HBP until March 01, 2023 was performed. Random and fixed effects meta-analyses of the effect of pacing technology on outcomes were performed. Study outcomes included pacing metrics, QRS duration, lead revision, procedure parameters, all-cause mortality and heart failure hospitalization (HFH). Overall, 10 studies with 1596 patients were included. Implant success rate was higher in LBBaP compared with HBP (RR 1.24, 95% CI: 1.08 to 1.42, p = .002). LBBaP was associated with lower capture threshold at implantation (mean difference (MD) -0.62 V, 95% CI: -0.74 to -0.51 V, p < .0001) and at follow-up (MD -0.74 V, 95% CI: -0.96 to -0.53, p < .0001), shorter procedure duration (MD -14.66 min, 95% CI: -23.54 to -5.78, p = .001) and shorter fluoroscopy time (MD -4.2 min, 95% CI: -8.4 to -0.0, p = .05). Compared with HBP, LBBaP was associated with a decreased risk of all-cause mortality (RR: 0.50, 95% CI: 0.33 to 0.77, p = .002) and HFH (RR: 0.57, 95% CI: 0.33 to 1.00, p = .05). No statistical differences were found in lead revisions and QRS duration before and after pacing. CONCLUSION: This meta-analysis found that LBBaP was superior to HBP regarding pacing metrics and implant success rate as an initial pacing strategy, although absence of head-to-head randomized comparison warrants caution in interpretation of the results.


Subject(s)
Bundle of His , Ventricular Septum , Humans , Heart Ventricles , Reoperation , Fluoroscopy , Cardiac Pacing, Artificial , Electrocardiography , Treatment Outcome
5.
Eur Heart J ; 44(45): 4771-4780, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37622660

ABSTRACT

Imaging plays an integral role in all aspects of managing heart disease and cardiac imaging is a core competency of cardiologists. The adequate delivery of cardiac imaging services requires expertise in both imaging methodology-with specific adaptations to imaging of the heart-as well as intricate knowledge of heart disease. The European Society of Cardiology (ESC) and the European Association of Cardiovascular Imaging have developed and implemented a successful education and certification programme for all cardiac imaging modalities. This programme equips cardiologists to provide high quality competency-based cardiac imaging services ensuring they are adequately trained and competent in the entire process of cardiac imaging, from the clinical indication via selecting the best imaging test to answer the clinical question, to image acquisition, analysis, interpretation, storage, repository, and results dissemination. This statement emphasizes the need for competency-based cardiac imaging delivery which is key to optimal, effective and efficient, patient care.


Subject(s)
Cardiology , Cardiovascular Nursing , Heart Diseases , Heart Failure , Humans , Heart
6.
Eur Heart J Cardiovasc Imaging ; 24(11): 1415-1424, 2023 Oct 27.
Article in English | MEDLINE | ID: mdl-37622662

ABSTRACT

Imaging plays an integral role in all aspects of managing heart disease and cardiac imaging is a core competency of cardiologists. The adequate delivery of cardiac imaging services requires expertise in both imaging methodology-with specific adaptations to imaging of the heart-as well as intricate knowledge of heart disease. The European Society of Cardiology (ESC) and the European Association of Cardiovascular Imaging have developed and implemented a successful education and certification programme for all cardiac imaging modalities. This programme equips cardiologists to provide high quality competency-based cardiac imaging services ensuring they are adequately trained and competent in the entire process of cardiac imaging, from the clinical indication via selecting the best imaging test to answer the clinical question, to image acquisition, analysis, interpretation, storage, repository, and results dissemination. This statement emphasizes the need for competency-based cardiac imaging delivery which is key to optimal, effective and efficient, patient care.


Subject(s)
Cardiology , Cardiovascular Nursing , Heart Diseases , Heart Failure , Humans , Heart
7.
Eur J Heart Fail ; 25(7): 936-955, 2023 07.
Article in English | MEDLINE | ID: mdl-37461163

ABSTRACT

Heart failure with preserved ejection fraction (HFpEF) represents a highly heterogeneous clinical syndrome affected in its development and progression by many comorbidities. The left ventricular diastolic dysfunction may be a manifestation of various combinations of cardiovascular, metabolic, pulmonary, renal, and geriatric conditions. Thus, in addition to treatment with sodium-glucose cotransporter 2 inhibitors in all patients, the most effective method of improving clinical outcomes may be therapy tailored to each patient's clinical profile. To better outline a phenotype-based approach for the treatment of HFpEF, in this joint position paper, the Heart Failure Association of the European Society of Cardiology, the European Heart Rhythm Association and the European Hypertension Society, have developed an algorithm to identify the most common HFpEF phenotypes and identify the evidence-based treatment strategy for each, while taking into account the complexities of multiple comorbidities and polypharmacy.


Subject(s)
Cardiology , Heart Failure , Hypertension , Humans , Heart Failure/drug therapy , Stroke Volume , Hypertension/drug therapy , Phenotype , Decision Making , Ventricular Function, Left
8.
Lancet ; 402(10396): 118-128, 2023 07 08.
Article in English | MEDLINE | ID: mdl-37331368

ABSTRACT

BACKGROUND: Etripamil is a fast-acting, intranasally administered calcium-channel blocker in development for on-demand therapy outside a health-care setting for paroxysmal supraventricular tachycardia. We aimed to evaluate the efficacy and safety of etripamil 70 mg nasal spray using a symptom-prompted, repeat-dose regimen for acute conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm within 30 min. METHODS: RAPID was a multicentre, randomised, placebo-controlled, event-driven trial, conducted at 160 sites in North America and Europe as part 2 of the NODE-301 study. Eligible patients were aged at least 18 years and had a history of paroxysmal supraventricular tachycardia with sustained, symptomatic episodes (≥20 min) as documented by electrocardiogram. Patients were administered two test doses of intranasal etripamil (each 70 mg, 10 min apart) during sinus rhythm; those who tolerated the test doses were randomly assigned (1:1) using an interactive response technology system to receive either etripamil or placebo. Prompted by symptoms of paroxysmal supraventricular tachycardia, patients self-administered a first dose of intranasal 70 mg etripamil or placebo and, if symptoms persisted beyond 10 min, a repeat dose. Continuously recorded electrocardiographic data were adjudicated, by individuals masked to patient assignment, for the primary endpoint of time to conversion of paroxysmal supraventricular tachycardia to sinus rhythm for at least 30 s within 30 min after the first dose, which was measured in all patients who administered blinded study drug for a confirmed atrioventricular-nodal-dependent event. Safety outcomes were assessed in all patients who self-administered blinded study drug for an episode of perceived paroxysmal supraventricular tachycardia. This trial is registered at ClinicalTrials.gov, NCT03464019, and is complete. FINDINGS: Between Oct 13, 2020, and July 20, 2022, among 692 patients randomly assigned, 184 (99 from the etripamil group and 85 from the placebo group) self-administered study drug for atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia, with diagnosis and timing confirmed. Kaplan-Meier estimates of conversion rates by 30 min were 64% (63/99) with etripamil and 31% (26/85) with placebo (hazard ratio 2·62; 95% CI 1·66-4·15; p<0·0001). Median time to conversion was 17·2 min (95% CI 13·4-26·5) with the etripamil regimen versus 53·5 min (38·7-87·3) with placebo. Prespecified sensitivity analyses of the primary assessment were conducted to test robustness, yielding supporting results. Treatment-emergent adverse events occurred in 68 (50%) of 99 patients treated with etripamil and 12 (11%) of 85 patients in the placebo group, most of which were located at the administration site and were mild or moderate, and all of which were transient and resolved without intervention. Adverse events occurring in at least 5% of patients treated with etripamil were nasal discomfort (23%), nasal congestion (13%), and rhinorrhea (9%). No serious etripamil-related adverse events or deaths were reported. INTERPRETATION: Using a symptom-prompted, self-administered, initial and optional-repeat-dosing regimen, intranasal etripamil was well tolerated, safe, and superior to placebo for the rapid conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm. This approach could empower patients to treat paroxysmal supraventricular tachycardia themselves outside of a health-care setting, and has the potential to reduce the need for additional medical interventions, such as intravenous medications given in an acute-care setting. FUNDING: Milestone Pharmaceuticals.


Subject(s)
Tachycardia, Paroxysmal , Tachycardia, Supraventricular , Tachycardia, Ventricular , Humans , Adolescent , Adult , Tachycardia, Supraventricular/drug therapy , Tachycardia, Paroxysmal/drug therapy , Benzoates/therapeutic use , Double-Blind Method
9.
Europace ; 25(6)2023 06 02.
Article in English | MEDLINE | ID: mdl-37354453

ABSTRACT

AIMS: Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice. Episodes may stop spontaneously (paroxysmal AF); may terminate only via intervention (persistent AF); or may persist indefinitely (permanent AF) (see European and American guidelines, referenced below, for more precise definitions). Recently, there has been renewed interest in an approach to terminate AF acutely referred to as 'pill-in-the-pocket' (PITP). The PITP is recognized in both the US and European guidelines as an effective option using an oral antiarrhythmic drug for acute conversion of acute/recent-onset AF. However, how PITP is currently used has not been systematically evaluated. METHODS AND RESULTS: The recently published Antiarrhythmic Interventions for Managing Atrial Fibrillation (AIM-AF) survey included questions regarding current PITP usage, stratified by US vs. European countries surveyed, by representative countries within Europe, and by cardiologists vs. electrophysiologists. This manuscript presents the data from this planned sub-study. Our survey revealed that clinicians in both the USA and Europe consider PITP in about a quarter of their patients, mostly for recent-onset AF with minimal or no structural heart disease (guideline appropriate). However, significant deviations exist. See the Graphical abstract for a summary of the data. CONCLUSION: Our findings highlight the frequent use of PITP and the need for further physician education about appropriate and optimal use of this strategy.


Subject(s)
Anti-Arrhythmia Agents , Atrial Fibrillation , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Atrial Fibrillation/epidemiology , Europe
11.
Kardiol Pol ; 2023 Mar 16.
Article in English | MEDLINE | ID: mdl-36929302

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia and places a significant burden on individuals as well as the healthcare system. AF management requires a multidisciplinary approach in which tackling comorbidities is an important aspect. AIMS: To evaluate how multimorbidity is currently assessed and managed and to determine if interdisciplinary care is undertaken. METHODS: A 21-item online survey was undertaken over four weeks as part of the EHRA-PATHS study examining comorbidities in Atrial Fibrillation and distributed to European Heart Rhythm Association members in Europe. RESULTS: A total of 341 eligible responses were received of which 35 (10%) were from Polish physicians. Compared to other European locations, the rates of specialist services and referrals varied but were not significantly different. However, there were higher numbers of specialised services reported in Poland compared to the rest of Europe for hypertension (57% vs. 37%; P = 0.02) and palpitations/arrhythmias (63% vs. 41%; P = 0.01) and the rates of sleep apnea services tended to be lower (20% vs. 34%; P = 0.10) and comprehensive geriatric care (14% vs. 36%; P = 0.01). The only statistical difference between Poland and the rest of Europe in reasons for referral rates was the barrier relating to insurance and financial reasons (31% vs. 11%; P <0.01, respectively). CONCLUSIONS: There is a clear need for an integrated approach to patients with AF and associated comorbidities. Prepardeness of Polish physicians to deliver such care seems to be similar to other European countries but may be hampered by financial obstacles.

12.
Europace ; 25(1): 199-210, 2023 02 08.
Article in English | MEDLINE | ID: mdl-36753478

ABSTRACT

To develop a suite of quality indicators (QIs) for the management of patients with ventricular arrhythmias (VA) and the prevention of sudden cardiac death (SCD). The Working Group comprised experts in heart rhythm management including Task Force members of the 2022 European Society of Cardiology (ESC) Clinical Practice Guidelines for the management of patients with VA and the prevention of SCD, members of the European Heart Rhythm Association, international experts, and a patient representative. We followed the ESC methodology for QI development, which involves (i) the identification of the key domains of care for the management of patients with VA and the prevention of SCD by constructing a conceptual framework of care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. We identified eight domains of care for the management of patients with VA and the prevention of SCD: (i) structural framework, (ii) screening and diagnosis, (iii) risk stratification, (iv) patient education and lifestyle modification, (v) pharmacological treatment, (vi) device therapy, (vii) catheter ablation, and (viii) outcomes, which included 17 main and 4 secondary QIs across these domains. Following a standardized methodology, we developed 21 QIs for the management of patients with VA and the prevention of SCD. The implementation of these QIs will improve the care and outcomes of patients with VA and contribute to the prevention of SCD.


Subject(s)
Cardiology , Quality Indicators, Health Care , Humans , Arrhythmias, Cardiac/complications , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/therapy , Death, Sudden, Cardiac/prevention & control
13.
Europace ; 25(1): 6-27, 2023 02 08.
Article in English | MEDLINE | ID: mdl-35894842

ABSTRACT

Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI.


Subject(s)
Atrial Fibrillation , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Artificial Intelligence , Early Diagnosis , Consensus , Cognition , Stroke/prevention & control
14.
Eur Heart J Qual Care Clin Outcomes ; 9(6): 609-620, 2023 09 12.
Article in English | MEDLINE | ID: mdl-36243903

ABSTRACT

AIMS: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation. METHODS AND RESULTS: We used the EuroHeart methodology for the development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach a consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data. CONCLUSION: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs, and post-marketing surveillance of devices and pharmacotherapies.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Treatment Outcome , Randomized Controlled Trials as Topic , Atrial Flutter/epidemiology , Atrial Flutter/surgery , Catheter Ablation/methods
15.
J Vasc Access ; : 11297298221133883, 2022 Nov 08.
Article in English | MEDLINE | ID: mdl-36349374

ABSTRACT

INTRODUCTION: The current Spanish Clinical Guidelines on Vascular Access for Hemodialysis support the need for surveillance and monitoring of vascular access (VA) to avoid complications. Ultrasound dilution (UD) methods are accepted for the evaluation of VA flow and Transonic® has established the gold standard method for the measurement. The DMed NephroFlow (NIPRO®) device, based on UD method has recently been incorporated. We report a comparative study between the classic Transonic® versus the new NephroFlow® device. MATERIAL AND METHODS: For two consecutive months, measurements of VA flow using both referred systems were performed in patients with a native arteriovenous fistula (AVF) or a graft (AVG) on hemodialysis (HD) in our unit. Both studies were undertaken according to the usual recommendations: VA flow of 250 ml/min, ultrafiltration rate without modifications, both needles in the same vein, and always in the first hour of the HD session. RESULTS: Forty-five patients were included: 17 women and 28 men, mean age of 67 ± 12 years. Thirty patients were diabetic. The baseline meantime on HD was 51 ± 39 months (range: 3-163). Type of VA was: 17 patients radio-cephalic AVF, 17 brachiocephalic AVF, 7 brachiobasilic AVF, and 3 with a graft. The mean flow estimated by the Transonic® was 1222 ± 805 ml/min and the estimated flow by the NephroFlow® device was 1252 ± 975 ml/min. Good reliability between Transonic® and NephroFlow® was observed, with a reliability index of Cronbach's Alpha of 0.927 and an Intraclass Correlation Index of 0.928. CONCLUSIONS: The NephroFlow® device seems comparable with the accepted gold standard UD method for estimating VA flow. More studies must be performed to verify these results. However, they should be considered for the surveillance and monitoring of VA flow, in agreement with the Spanish Guidelines.

16.
Cardiology ; 147(5-6): 566-577, 2022.
Article in English | MEDLINE | ID: mdl-36282074

ABSTRACT

INTRODUCTION: Intravenous vernakalant is a therapeutic option for symptomatic, recent-onset atrial fibrillation (AF). This secondary analysis from the large SPECTRUM study assessed the safety and effectiveness of vernakalant when used in the emergency department setting (ED group) or in an inpatient hospital setting (non-ED group). METHODS: This post hoc analysis of the international, observational, post-authorization SPECTRUM study included 1,289 and 720 recent-onset AF episodes in adults in the ED and non-ED groups, respectively. Safety endpoints included the evaluation of pre-defined health outcomes of interest (HOIs) and other serious adverse events (SAEs) during vernakalant treatment and during the first 24 h after the last infusion. Effectiveness endpoints comprised the rate of successful vernakalant cardioversion, the time from the start of the vernakalant infusion to cardioversion, and the length of hospital stay. Data were analysed using descriptive statistics. RESULTS: The safety profile of vernakalant was similar in the ED and non-ED groups. In the ED group, 12 pre-defined HOIs were reported in 11 patients (0.9%); all but one occurred within 2 h after start of the first infusion. These events comprised nine significant bradycardia cases, of which one was associated with transient hypotension and three with sinus arrest, and 2 cases of atrial flutter with 1:1 conduction. Five other SAEs were reported. All patients with vernakalant-related events recovered without sequelae. No Torsade de Pointes, ventricular fibrillation, or deaths occurred. Successful cardioversion was reported in 67.8% (95% confidence interval: 65.2-70.4) and 66.4% (62.5-70.1) of episodes, with a median time to conversion of 11.0 and 10.0 min in the ED and non-ED groups, respectively. Patients had a median length of hospital stay of 7.4 h and 17.1 h in the ED and non-ED groups, respectively. CONCLUSION: Intravenous vernakalant was well tolerated with similar cardioversion rates in patients treated in the ED or non-ED setting and does not require admission to a coronary care unit or intensive care unit. First-line treatment with vernakalant could allow an early discharge in patients with recent-onset AF treated in the ED.


Subject(s)
Atrial Fibrillation , Adult , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/chemically induced , Electric Countershock , Anti-Arrhythmia Agents/adverse effects , Treatment Outcome , Emergency Service, Hospital
17.
Europace ; 24(12): 2004-2014, 2022 Dec 09.
Article in English | MEDLINE | ID: mdl-36036694

ABSTRACT

As part of the EHRS-PATHS study examining comorbidities in atrial fibrillation (AF) across Europe, the aim was (i) to evaluate how multimorbidity is currently addressed by clinicians during AF treatment to characterize the treatment structure and (ii) to assess how the interdisciplinary management of multimorbid AF is currently conducted. An online survey was distributed among European Heart Rhythm Association (EHRA) members in Europe that included 21 questions and a free-text option for comments on detection, assessment, and management of AF-related comorbidities. A total of 451 responses were received with 339 responses eligible for inclusion. Of these, 221 were male (66%), 300 (91.5%) were physicians, and 196 (57.8%) were working in academic university teaching hospitals. Half of the respondents managed between 20 and 50 patients per month with multimorbid AF. Varying rates of specialist services and referral to these services were available at each location (e.g. heart failure and diabetes), with a greater number of specialist services available at academic university teaching hospitals compared with non-teaching hospitals [e.g. anticoagulation clinic 92 (47%) vs. 50 (35%), P < 0.03]. Barriers to referring to specialist services for AF comorbidities included lack of integrated care model (n = 174, 51%), organizational or institutional issues (n = 145, 43%), and issues with patient adherence (n = 126, 37%), highlighting the need for organizational restructuring and developing an integrated collaborative evidenced-based approach to multimorbid AF care. The survey and analyses of free-text comments demonstrated the need for systematic, integrated management of AF-related comorbidities, and these results will inform the next phases of the EHRA-PATHS study.


Subject(s)
Atrial Fibrillation , Stroke , Humans , Male , Female , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/therapy , Anticoagulants/therapeutic use , Stroke/diagnosis , Surveys and Questionnaires , Europe/epidemiology
19.
Rev Port Cardiol ; 41(10): 823-830, 2022 10.
Article in English | MEDLINE | ID: mdl-35784098

ABSTRACT

Background: Chronic use of Angiotensin-converting enzyme (ACE) inhibitors (ACEi) and aldosterone-receptor blockers (ARB) is not associated with worse outcomes in patients with COVID-19. However, evidence on the impact of their discontinuation during hospital admission is scarce. Our aim was to determine whether withdrawal of ACEi, ARB and mineralocorticoid receptor antagonists (MRA) is associated with all-cause mortality in a real-life large cohort of patients with SARS-CoV-2 infection. Methods: Observational cohort study from a large referral center from 1 March 2020 to 20 April 2020. Withdrawal of renin-angiotensin-aldosterone system inhibitors was defined as the absence of any received dose during hospital admission in patients receiving chronic treatment. Prescriptions during admission were confirmed by data from the central pharmacy computerized system. Results: A total of 2042 patients (mean age 68.4±17.6, 57.1% male) with confirmed COVID-19 were included. During a median follow-up of 57 (21-55) days, 583 (28.6%) died. Prior to hospital admission 468 (22.9%), 343 (16.8%) and 83 (4.1%) patients were receiving ACEi, ARB and MRA respectively. During the study period, 216 (46.2%), 193 (56.3%) and 41 (49.4%) were withdrawn from the corresponding drug. After adjusting for age, cardiovascular risk factors, baseline comorbidities and in-hospital COVID-19 dedicated treatment, withdrawal of ACE inhibitors (hazard ration [HR] 1.48 [95% confidence interval -CI- 1.16-1.89]) and MRA (HR 2.01 [95% CI 1.30-3.10]) were shown to be independent predictors of all-cause mortality. No independent relationship between ARB withdrawal and mortality was observed. Conclusion: ACEi and MRA withdrawal were associated with higher mortality. Strong consideration should be given to not discontinuing these medications during hospital admission.


Introdução: O uso crónico de inibidores da ECA (IECA) e de antagonistas dos recetores de aldosterona (ARA) não está associado a resultados piores em doentes com Covid-19. No entanto, a evidência relativa ao impacto da sua retirada durante a admissão hospitalar é escassa. O nosso objetivo foi determinar se a retirada do IECA, ARA e antagonistas dos recetores dos mineralocorticóides (ARM) está associada à mortalidade por todas as causas numa grande coorte real de doentes com infeção por SRA-CoV-2. Métodos: Estudo coorte observacional a partir de um grande centro de referência de 1 de março de 2020 a 20 de abril de 2020. A retirada dos inibidores do sistema RAAS foi definida como a ausência de qualquer dose recebida durante a admissão hospitalar em doentes que recebem tratamento prolongado. As prescrições durante a admissão foram confirmadas por dados do sistema informático da farmácia central. Resultados: Um total de 2042 doentes (idade média de 68,4 ±17,6, 57,1% do sexo masculino) com COVID-19 confirmado foram incluídos. Durante um acompanhamento médio de 57 (21-55) dias, 583 (28,6%) morreram. Conclusão: A retirada do IECA e do ARM foi associada a uma mortalidade mais elevada. Deve ser dada grande atenção para não interromper estes medicamentos durante a admissão hospitalar.


Subject(s)
COVID-19 Drug Treatment , Aged , Aged, 80 and over , Aldosterone , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Angiotensins , Antihypertensive Agents/therapeutic use , Female , Humans , Male , Middle Aged , Mineralocorticoid Receptor Antagonists/therapeutic use , Renin , Retrospective Studies , SARS-CoV-2
20.
Europace ; 24(10): 1541-1547, 2022 10 13.
Article in English | MEDLINE | ID: mdl-35531864

ABSTRACT

There is an increasing pressure on demonstrating the value of medical interventions and medical technologies resulting in the proposal of new approaches for implementation in the daily practice of innovative treatments that might carry a substantial cost. While originally mainly adopted by pharmaceutical companies, in recent years medical technology companies have initiated novel value-based arrangements for using medical devices, in the form of 'outcomes-based contracts', 'performance-based contracts', or 'risk-sharing agreements'. These are all characterized by linking coverage, reimbursement, or payment for the innovative treatment to the attainment of pre-specified clinical outcomes. Risk-sharing agreements have been promoted also in the field of electrophysiology and offer the possibility to demonstrate the value of specific innovative technologies proposed in this rapidly advancing field, while relieving hospitals from taking on the whole financial risk themselves. Physicians deeply involved in the field of devices and technologies for arrhythmia management and invasive electrophysiology need to be prepared for involvement as stakeholders. This may imply engagement in the evaluation of risk-sharing agreements and specifically, in the process of assessment of technology performances or patient outcomes. Scientific Associations may have an important role in promoting the basis for value-based assessments, in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatments, and in promoting large-scale registries for a precise assessment of patient outcomes and of specific technologies' performance.


Subject(s)
Electrophysiologic Techniques, Cardiac , Risk Sharing, Financial , Drug Industry , Humans
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