The Atrial Fibrillation Better Care (ABC) Pathway and Clinical Outcomes in Patients with Atrial Fibrillation: the Prospective Murcia AF Project Phase II Cohort.

BACKGROUND: The Atrial fibrillation Better Care (ABC) pathway was proposed for a more holistic or integrated care approach to atrial fibrillation (AF) management. We investigated whether adherence with the ABC pathway reduced the risk of adverse clinical outcomes in real-world AF patients starting vitamin K antagonist (VKAs) therapy. METHODS: Prospective cohort study including AF outpatients starting VKA therapy from July 2016 to June 2018. Patients were considered as adherent if all ABC pathway criteria (A: Avoid stroke; B: Better symptom control; and C: Cardiovascular risk factors/comorbidities management) were fulfilled. The primary endpoints were all-cause mortality, net clinical outcomes (NCOs), major adverse cardiovascular events (MACE), and composite thrombotic/thromboembolic events at 2 years. RESULTS: We enrolled 1045 patients (51.6% female; median age 77 [70-83] years). Of these, 63.0% (658) were adherent to the ABC pathway and 37% (387) were considered non-adherent. Compared to non-adherent patients, those who were ABC adherent had lower event rates for all-cause mortality (13.76 vs. 6.56; p<0.001), NCOs (19.65 vs. 11.94; p<0.001), and MACE (11.88 vs. 7.75; p=0.006) during the follow-up. Adjusted Cox regression analyses demonstrated that the ABC pathway adherent care reduced the risks of all-cause mortality (aHR 0.57, 95% CI 0.42-0.78), NCOs (aHR 0.72, 95% CI 0.56-0.92), and cardiovascular mortality (aHR 0.54, 95% CI 0.32-0.90). Event-free survivals for all-cause mortality, NCOs (both log-rank p-values <0.001), and MACE (log-rank p-value = 0.004) were also higher in ABC pathway adherent patients. CONCLUSIONS: In this real-world prospective cohort of AF patients starting VKA therapy, adherence to the ABC pathway management at baseline significantly reduced the risk of NCOs, all-cause mortality, and cardiovascular death at 2 years.

Successful ovarian stimulation and pregnancy in an infertile woman with chronic myeloid leukemia.

BACKGROUND: Tyrosine kinase inhibitors (TKI) treatment has transformed chronic myeloid leukemia (CML) from a fatal neoplasm to a chronic disease with normal life expectancies. Indeed, half of CML patients are able to discontinue TKI without relapse. However, it seems clearly demonstrated that exposure to TKI may result in fetal malformations. Regarding its effects on fertility, preclinical studies and clinical case reports provide inconclusive evidence. Furthermore, due to the risk of CML relapse after TKI discontinuation, the optimal time to stop TKI represents a real dilemma. CASE REPORT: We describe a 23-year-old woman who, after more than 6 years with imatinib and 1 year in deep molecular response [(DMR), MR ≥ 4], interrupted treatment to become pregnant. After 2 failed artificial insemination cycles, she underwent one process of controlled ovarian stimulation, achieving 2 blastocyst-embryos. In the meantime, BCR-ABL1IS levels increased despite interferon-alpha therapy, she lost the mayor molecular response (MMR), and the 2 embryos had to be cryopreserved. A stable second MR ≥ 4.0 was again obtained with nilotinib, and after stopping it, the 2 blastocyst-embryo transfers were unsuccessfully performed. Under DMR, a second ovarian stimulation and in vitro fertilization (IVF) was performed and 1 blastocyst embryo was transferred. This time, she became pregnant and a healthy baby was born. After more than 3 years of follow-up, she remains in treatment-free remission (TFR). CONCLUSION: Compared with imatinib, nilotinib achieves earlier and deeper MR that allows safe and timely pregnancies in infertile CML women through IVF process, while patients remain in TFR after delivery.

Thrombosis and infections associated with PICC in onco-hematological patients, what is their relevance?

PURPOSE: Peripherally inserted central venous catheters (PICC) in the onco-hematological patients may be associated with thrombosis or infections that may have short- to medium-term repercussions. MATERIAL AND METHODS: Single-centre retrospective analysis of a prospectively collected cohort. Primary objective was to establish the PICC-thrombosis and infections incidence. Secondary objectives were to analyze profile of patients suffering from these complications and variables associated with an increased likelihood of developing these events. RESULTS: 549 patients were recruited. 58.5% (n = 321) were oncology patients and 41.5% (n = 228) hematology patients. The incidence of PICC-associated thrombosis was 3.5% (n = 19). Thrombosis was associated with progression of the underlying malignant pathology in 10.6% (n = 2) of cases. No association was found between clinical variables analysed and development of thrombosis. Incidence of PICC-associated infections was 7.65% (n = 42). In the 30 days prior to PICC infection, 57.1% (n = 24) had a febrile syndrome of another focus, 73.8% (n = 11) had been hospitalized, 49.5% (n = 25) had a neutrophil count of 0-500 cells/mm3 and 47.6% (n = 20) had an episode of neutropenic fever. Variables significantly associated with the development of infection were hematological patients, high-flow PICC, 3-lm PICC or PICC insertion because of administration of vesicant therapy. CONCLUSIONS: Incidence of PICC-associated thrombosis is low and apparently less prognostically aggressive than other forms of thrombosis associated with cancer, without identify predictive factors. Infection was more prevalent and the identification of risk factors in our series could facilitate its prevention.

Polypharmacy and adverse events in atrial fibrillation: Main cause or reflection of multimorbidity?

BACKGROUND: Previous evidence indicated that atrial fibrillation (AF) patients with polypharmacy presented increased probability of adverse events. We investigated the prevalence of polypharmacy, risk factors for polypharmacy, and the impact of polypharmacy in clinical outcomes in a 'real-world' cohort of AF patients starting vitamin K antagonists (VKAs). METHODS: Prospective study including AF outpatients starting VKA therapy from July, 2016 to June, 2018. At inclusion, all concomitant drugs were carefully collected and recorded. Polypharmacy was defined as the intake of ≥ 5 concomitant drugs. During 2-years of follow-up, ischemic strokes/transient ischemic attacks (TIAs), fatal/nonfatal myocardial infarctions (MIs), bleeding events, venous thromboembolisms, and all-cause deaths were recorded. RESULTS: 1050 patients (51.5 % females, median age 77 [69-83] years) were included, and the prevalence of polypharmacy was 32.9 % (345). Female sex (OR 1.5; 95 % CI 1.11-2.03), hypertension (OR 2.53; 95 % CI 1.51-4.22), diabetes (OR 3.11; 95 % CI 2.31-4.17), vascular disease (OR 3.08; 95 % CI 2.19-4.33), heart failure (OR 1.86; 95 % CI 1.35-2.58) and dyslipidemia (OR 2.61; 95 % CI 1.9-3.58) were independently associated to the polypharmacy. Patients with polypharmacy showed significantly higher incidence of major bleeding, net clinical outcomes (composite of major bleeding, ischemic stroke/TIA, and mortality), MACE (composite of ischemic stroke/TIA, MI, and cardiovascular death), and composite thrombotic/thromboembolic events; being an independent risk factor for major bleeding (HR 1.77, 95 % CI 1.07-2.92), and composite thrombotic/thromboembolic events (HR 1.55, 95 % CI 1.05-2.31). CONCLUSION: In this "real world" AF cohort, polypharmacy was highly prevalent and conditioned worse prognosis due to its association with bleeding and thromboembolic events.

Relation of the 'Atrial Fibrillation Better Care (ABC) Pathway' to the Quality of Anticoagulation in Atrial Fibrillation Patients Taking Vitamin K Antagonists.

The Atrial Fibrillation Better Care (ABC) pathway was proposed for a more integrated atrial fibrillation (AF) care. We investigated if adherence to the ABC pathway was associated to the quality of anticoagulation control in a cohort of AF outpatients starting vitamin K antagonists (VKAs) between July 2016 and June 2018. Patients were considered adherent to the ABC pathway if they met all of its components. The time in therapeutic range (TTR) was estimated at one year. In total, 1045 patients (51.6% female; median age 77 years; 63% ABC pathway adherent) were included. At one year, 474 (51.6%) of 919 patients with international normalized ratio (INR) data for TTR estimation had a TTR < 65%. Among ABC pathway non-adherent patients, a greater proportion had TRT < 65% (56.4% vs. 43.6%, p = 0.025), and TTR < 70% (64.9% vs. 35.1%, p = 0.033), with lower mean TTR in non-adherent patients (59.4 ± 22.3% vs. 63.9 ± 21.1%; p = 0.004). Logistic regression models demonstrated that the ABC pathway adherence in its continuous (aOR: 0.75, 95% CI 0.59−0.96) and categorical (aOR: 0.75, 95% CI 0.57−0.98) forms was independently associated with TTR ≥ 65%. In this 'real-world' cohort of AF patients starting VKAs, the ABC pathway adherent patients had better TTR, and more ABC criteria fulfilled increased the probability of achieving good TTR.