[Telemonitoring patients with chronic heart failure. Results from a pilot study in the Veneto Region, Italy]. / Il telemonitoraggio territoriale dei pazienti affetti da scompenso cardiaco cronico. I risultati di uno studio pilota nel Veneto.

BACKGROUND: Remote monitoring of patients with chronic heart failure (HF) can prevent acute episodes of HF, optimize treatment, reduce emergency room (ER) visits and hospitalizations, and improve quality of life of patients and caregivers. In current clinical practice, however, the most appropriate model is still under debate. We aimed to evaluate the impact of a new remote telemonitoring (TM) system in the clinical management of HF patients on the reduction of hospitalizations and ER admissions and on possible related-economic benefits. METHODS: A working group participated by primary care and family practitioners, cardiologists, home care nurses of the 8th Local Health Unit of the Veneto Region, Italy, has established a new operating procedure for TM chronic HF patients, identifying the clinical profiles and the inclusion/exclusion criteria of enrollment, the clinical parameters to be monitored, the input/output modalities of the information to/from the call center, the alarm criteria and the response procedures. Patients were profiled into three risk categories based on age, clinical characteristics, prognosis assessment, and social needs and provided with appropriate devices for remote measurement and transmission of blood pressure, heart rate, peripheral oxygen saturation (SpO2) and body weight. Clinical data, self-measured at home according to a predetermined schedule based on the patient's risk profile, were automatically transmitted to the operating center, generating, if above the threshold, a grading of alarms (green/cyan, yellow, red) and the consequent activation of the most appropriate response (returned phone calls to check patient's status, reporting to primary physician/family practitioner for clinical evaluation, notification to the HF outpatient clinic for an early follow-up visit, alerting medical emergency services). The number of hospitalizations and ER visits during the TM period was compared with the pre-TM equivalent for each individual patient. RESULTS: Overall, 22 patients with chronic HF were enrolled (mean age 82.3 ± 8.6 years, 17 males). The average duration of TM was 18.7 ± 8.8 months. Overall, 62 108 home measurements were performed and transmitted. The alarms received by the operating center were 4120 (6.6% of all measurements): 62% cyan, 30% yellow, 8% red. Most of the data above the threshold concerned weight gain (42.0%) and SpO2 variations (28.0%). During the observation period (TM period and pre-TM equivalent interval calculated for each individual patient), a total of 127 hospitalizations and 181 ED visits were recorded. Compared to the pre-TM period, there was a 66% reduction in hospitalizations for all causes (95 vs 32, p<0.001) and a 68% decrease in ED visits (137 vs 44, p<0.001). Similarly, hospitalizations and ED visits due to HF were reduced by 82% (p<0.001) and 66% (p<0.001), respectively, with a decrease in days of HF-related hospitalization from 211 to 48. Despite a higher cost for TM of € 6911.15, a total saving of € 64 103.87 was obtained for the reduction of expenses from € 8665.45 to € 2664.00 for ED visits and from € 71 627.93 to € 13 525.51 for HF hospitalizations. CONCLUSIONS: This pilot experience on remote monitoring HF patients proved to be effective in determining a significant reduction in ED visits and hospitalizations with a consequent significant economic benefit. Larger studies are needed to confirm this favorable outcome.

Mexiletine for ventricular arrhythmias in patients with chronic coronary syndrome: a cohort study.

BACKGROUND: The pharmacological therapy of ventricular arrhythmias in patients with unsuccessful or not feasible catheter ablation and contraindication or inefficacy to amiodarone and beta-blockers, is controversial. The present study investigated the effectiveness and tolerability of mexiletine in patients with recurrent ventricular arrhythmias and ischaemic heart disease, when the conventional antiarrhythmic therapy failed. METHODS: We enrolled all consecutive patients with unsuccessful/not feasible catheter ablation and ineffective/contraindicated amiodarone or beta-blockers, which started the mexiletine treatment for refractory ventricular tachycardia (VT) or ventricular fibrillation (VF) between January 2010 and January 2020. The primary endpoint was the total number of VT/VF episodes after the beginning of mexiletine therapy. The 2 secondary endpoints were the overall number of therapies released by implantable cardioverter-defibrillators (ICDs) and the discontinuation of the pharmacological therapy. The events occurring during the mexiletine treatment period were compared with those observed in a matched duration interval before the initiation of therapy. RESULTS: Thirty-four consecutive patients (27 males, 79.4%; mean age 74.0 ± 9.5 years) with ischaemic heart disease were finally analysed. The median of mexiletine treatment was 26.5 months (interquartile range: 18.75-38.25 months). After the mexiletine start, VT/VF episodes and ICD interventions significantly decreased (respectively: 74 vs 33 episodes, p = 0.002; 116 vs 52 interventions, p = 0.02) in comparison with a matched period without mexiletine. Six patients (13.9%) discontinued the treatment because of severe side effects. CONCLUSIONS: The treatment period following the mexiletine start was associated with a significant reduction of ventricular arrhythmias. The rate of side effects requiring dosage reduction or interruption was not neglectable.

Effects and clinical implications of sacubitril/valsartan on left ventricular reverse remodeling in patients affected by chronic heart failure: A 24-month follow-up.

BACKGROUND: Compared to angiotensin inhibition, angiotensin-neprilysin "blockade" improves mortality and reduces hospitalizations in patients with heart failure (HF) with reduced ejection fraction (EF). Sacubitril/valsartan is known to influence left ventricular (LV) reverse remodeling with systolic function improvement, although underlying mechanisms remain partially unclear. Our objectives were to evaluate whether sacubitril/valsartan promotes LV remodeling and improves LV ejection fraction (LVEF) (above the 35% threshold by echocardiographic evaluation) and to identify predictors of reverse remodeling in a real-world setting. METHODS: New York Heart Association (NYHA) class II-III patients with EF ≤ 35% were consecutively enrolled. All patients were on optimal medical therapy on the initiation of sacubitril/valsartan therapy. Full clinical and multi-parametric echocardiographic evaluation, electrocardiogram, and laboratory tests were performed at baseline and after 3, 6, 12, and 24 months. RESULTS: In total, 69 patients were recruited from July 2016 to August 2018. Reverse remodeling was observed in 57.7% (30/52) of patients, occurring within 3, 6, 12, and 24 months in 2, 11, 13, and 4 patients, respectively. Twenty-four (46%) patients showed LVEF improvement above the threshold of 35% during follow-up, occurring in 1, 10, 9, and 4 patients within 3, 6, 12, and 24 months, respectively. Primitive dilated cardiomyopathy and female gender were identified as significant predictors of reverse remodeling. NYHA class was improved in both remodeling and non-remodeling patients. CONCLUSION: Sacubitril/valsartan promotes favorable cardiac remodeling and significantly improves LVEF in a significant proportion of HF patients within 24 months, both in NYHA class II and III patients with HF.

Miocardiopatia de tako-tsubo secundaria a asma bronquial en una niña de 12 años tras cirugía ortopédica / Tako-tsubo cardiomyopathy in a 12-year-old girl secondary to acute asthma during orthopedic surgery

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Coexistence and outcome of coronary artery disease in Takotsubo syndrome.

AIMS: Takotsubo syndrome (TTS) is an acute heart failure syndrome, which shares many features with acute coronary syndrome (ACS). Although TTS was initially described with angiographically normal coronary arteries, smaller studies recently indicated a potential coexistence of coronary artery disease (CAD) in TTS patients. This study aimed to determine the coexistence, features, and prognostic role of CAD in a large cohort of patients with TTS. METHODS AND RESULTS: Coronary anatomy and CAD were studied in patients diagnosed with TTS. Inclusion criteria were compliance with the International Takotsubo Diagnostic Criteria for TTS, and availability of original coronary angiographies with ventriculography performed during the acute phase. Exclusion criteria were missing views, poor quality of angiography loops, and angiography without ventriculography. A total of 1016 TTS patients were studied. Of those, 23.0% had obstructive CAD, 41.2% had non-obstructive CAD, and 35.7% had angiographically normal coronary arteries. A total of 47 patients (4.6%) underwent percutaneous coronary intervention, and 3 patients had acute and 8 had chronic coronary artery occlusion concomitant with TTS, respectively. The presence of CAD was associated with increased incidence of shock, ventilation, and death from any cause. After adjusting for confounders, the presence of obstructive CAD was associated with mortality at 30 days. Takotsubo syndrome patients with obstructive CAD were at comparable risk for shock and death and nearly at twice the risk for ventilation compared to an age- and sex-matched ACS cohort. CONCLUSIONS: Coronary artery disease frequently coexists in TTS patients, presents with the whole spectrum of coronary pathology including acute coronary occlusion, and is associated with adverse outcome. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01947621.

An unusual case of AV block.

Nerium oleander is an evergreen small tree, very used in some countries such as India and in Sri Lanka as a self-medication method. We report a case of a 55 year-old man with intermittent, advanced AV block secondary to oleander intoxication.

Intraventricular Thrombus Formation and Embolism in Takotsubo Syndrome: Insights From the International Takotsubo Registry.

OBJECTIVE: Takotsubo syndrome (TTS) is characterized by acute left ventricular dysfunction, which can contribute to intraventricular thrombus and embolism. Still, prevalence and clinical impact of thrombus formation and embolic events on outcome of TTS patients remain unclear. This study aimed to investigate clinical features and outcomes of patients with and without intraventricular thrombus or embolism. Additionally, factors associated with thrombus formation or embolism, as well as predictors for mortality, were identified. Approach and Results: TTS patients enrolled in the International Takotsubo Registry at 28 centers in Australia, Europe, and the United States were dichotomized according to the occurrence/absence of intraventricular thrombus or embolism. Patients with intraventricular thrombus or embolism were defined as the ThrombEmb group. Of 1676 TTS patients, 56 (3.3%) patients developed intraventricular thrombus and/or embolism following TTS diagnosis (median time interval, 2.0 days [range, 0-38 days]). Patients in the ThrombEmb group had a different clinical profile including lower left ventricular ejection fraction, higher prevalence of the apical type, elevated levels of troponin and inflammatory markers, and higher prevalence of vascular disease. In a Firth bias-reduced penalized-likelihood logistic regression model apical type, left ventricular ejection fraction ≤30%, previous vascular disease, and a white blood cell count on admission >10×103 cells/µL emerged as independent predictors for thrombus formation or embolism. CONCLUSIONS: Intraventricular thrombus or embolism occur in 3.3% of patients in the acute phase of TTS. A simple risk score including clinical parameters associated with intraventricular thrombus formation or embolism identifies patients at increased risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01947621.

Management of a patient with heart failure by sacubitril/valsartan: improvement of functional capacity.

The main objectives of the treatment of heart failure (HF) are to improve patient clinical status, functional capacity and quality of life, as well as reducing re-hospitalization rate and mortality. A new compound, consisting of an angiotensin-receptor blocker (ARB) (valsartan) and a neprilysin (NEP) inhibitor (sacubitril), belonging to the newly established class of angiotensin receptor-neprilysin inhibitors (ARNIs) showed marked efficacy, without any relevant safety issue, in the treatment of patients with HF. We report a case of a 48 year old male with HF with reduced ejection fraction (HFrEF) due to hypertensive cardiomyopathy (New York Heart Association [NYHA] class III). Therapy with sacubitril/valsartan was initiated after some years of other treatments, which did not lead to any positive outcome in HF, quality of life and clinical functions. After only 1 month of sacubitril/valsartan therapy, the patient reported a significant improvement in quality of life, and in 6 months his NYHA class switched from III to I.

Single vs double antiplatelet therapy in acute coronary syndrome: Predictors of bleeding after coronary artery bypass grafting.

AIM: To investigate the contribution of anti-platelet therapy and derangements of pre-operative classical coagulation and thromboelastometry parameters to major bleeding post-coronary artery bypass grafting (CABG). METHODS: Two groups of CABG patients were studied: Group A, treated with aspirin alone (n = 50), and Group B treated with aspirin and clopidogrel (n = 50). Both had similar preoperative, clinical, biologic characteristics and operative management. Classic coagulation parameters and rotational thromboelastometry (ROTEM) profiles were determined preoperatively for both groups and the same heparin treatment was administered. ROTEM profiles (INTEM and EXTEM assays) were analyzed, both for traditional parameters, and thrombin generation potential, expressed by area-under-curve (AUC). RESULTS: There was no significant difference between rates of major bleeding between patients treated with aspirin alone, compared with those treated with aspirin and clopidogrel (12% vs 16%, P = 0.77). In the 14 cases of major bleeding, pre-operative classic coagulation and traditional ROTEM parameters were comparable. Conversely we observed that the AUC in the EXTEM test was significantly lower in bleeders (5030 ± 1115 Ohm*min) than non-bleeders (6568 ± 548 Ohm*min) (P < 0.0001). CONCLUSION: We observed that patients with a low AUC value were at a significantly higher risk of bleeding compared to patients with higher AUC, regardless of antiplatelet treatment. This suggests that thrombin generation potential, irrespective of the degree of platelet inhibition, correlates with surgical bleeding.

The danger of using a sledgehammer to crack a nut: ROTEM-guided administration of recombinant activated factor VII in a patient with refractory bleeding post-ventricular assist device implantation.

Recombinant activated factor VII (rFVIIa) is currently approved for treating or preventing hemorrhage in patients with hemophilia, Glanzmann's thrombasthenia, or congenital FVII deficiency. Its "off-label" use for massive bleeding in the setting of trauma or surgery has been increasing because of demonstrated efficacy. However, the use of rFVIIa also carries a high thrombo-embolic risk. This is particularly true in cardiac surgery patients, especially those treated with mechanical circulatory support. We describe the case of a patient treated with a biventricular assist device in our center, in whom severe bleeding was treated in a targeted manner, using rotational thromboelastometry to guide administration and dosing of rFVIIa. A comprehensive review of the emerging literature on the use of rFVIIa postventricular assist device implantation accompanies the case to highlight the need for careful selection of prohemostatic agents in this high-risk group.

Alternative splicing of platelet cyclooxygenase-2 mRNA in patients after coronary artery bypass grafting.

Recently, we cloned from platelet mRNA a novel cyclooxygenase (COX)-2 splice variant, designated COX-2a, which is characterized by a partial deletion of exon 5. Preliminary studies of mRNA distribution of COX-2 isoforms in platelets from coronary artery bypass grafting (CABG) patients showed a variable increase in COX-2a mRNA expression after cardiac surgery. Thus, we assessed whether this variant may play a functional role in these patients. We report a marked (about 200-fold) increase in the expression of COX-2a mRNA after CABG. Evidence is presented that ribosomal frame-shifting may correct the coding sequence resulting in the expression of a full-length COX-2a protein. In addition, a reading frame-corrected COX-2a mutant (COX-2a delta G) was generated by site-directed mutagenesis and expressed in COS-7 cells using an adenoviral expression system. However, COX-2a protein was not active in terms of prostaglandin formation. Thus, alternative mRNA splicing might represent an intriguing posttranscriptional mechanism to oppose a transcriptional activation of the COX-2 gene. Evolutionary, this mechanism may prevent COX-2-dependent thromboxane synthesis in the platelet, which would potentiate the likelihood of thrombosis; pharmacologically, this mechanism would prevent an aspirin-insensitive pathway of thromboxane formation.