Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

AIMS: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. METHODS AND RESULTS: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). CONCLUSION: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

Propensity score-matched analysis of effects of clinical characteristics and treatment on gender difference in outcomes after acute myocardial infarction.

The greater mortality observed in women compared to men after acute myocardial infarction remains unexplained. Using an analysis of pairs, matched on a conditional probability of being male (propensity score), we assessed the effect of the baseline characteristics and management on 30-day mortality. Consecutive patients were included from January 2006 to December 2007. Two propensity scores (for being male) were calculated, 1 from the baseline characteristics and 1 from both the baseline characteristics and treatment. Two matched cohorts were composed using 1:1 matching and computed using the best 8 digits of the propensity score. Paired analyses were performed using conditional regression analysis. During the study period, 3,510 patients were included in the registry; 1,119 (32%) were women. Compared to the men, the women were 10 years older, had more co-morbidities, less often underwent angiography and reperfusion, and received less medical treatment. The 30-day mortality rate was 12.3% (130 of 1,060) for the women and 7.2% (167 of 2,324) for the men (p <0.001). The 2 matched populations represented 1,298 and 1,168 patients. After matching using the baseline characteristics, the only difference in treatment was a lower rate of angiography and reperfusion, with a trend toward greater 30-day mortality in women. After matching using both baseline characteristics and treatment, the 30-day mortality was similar for the men and women, suggesting that the increased use of invasive procedures in women could potentially be beneficial. In conclusion, compared to men, the 30-day mortality is greater in women and explained primarily by differences in baseline characteristics and to a lesser degree by differences in management. The difference in the use of invasive procedures persisted after matching by characteristics. In contrast, after matching using the baseline characteristics and treatment, the 30-day mortality was comparable across the genders.

Immediate versus delayed angioplasty in infarct-related arteries with TIMI III flow and ST segment recovery: a matched comparison in acute myocardial infarction patients.

BACKGROUND: Early management of patients with patent infarct-related artery (IRA) and optimal ST resolution in ST elevation myocardial infarction (STEMI) has never been assessed. We compared immediate vs delayed PCI in these patients. METHODS: Matched comparison of immediate vs delayed (24 h) PCI in STEMI patients presenting with patent IRA, thrombus-containing lesion and ST resolution >or=70%. Patients were matched for duration of symptoms, intervention type, angiographic data, diabetes. Patients in immediate PCI group received standard therapy in the cathlab. Patients in delayed PCI group received dual antiplatelet therapy, antithrombins, and GPIIb-IIIa inhibitors until PCI. Primary endpoint was procedural success. Secondary endpoints were enzyme release and in-hospital adverse events. RESULTS: Seventy-eight patients were included: 39 per group. Average age 62 years, 75% males. There was a significantly higher procedural success rate in the delayed PCI group (95% success, Vs. 77% in the immediate group, P = 0.008). Initial thrombus burden score did not differ between immediate and delayed PCI groups, but improved significantly in the delayed group between baseline angiography and time of PCI (P = 0.039). There was no difference in major adverse events or bleeding complications between groups. Peak CK levels were significantly higher in the immediate versus delayed PCI group (P = 0.02), although there was no difference between groups in peak CK-MB, peak troponin, or peak CK-MB ratio. CONCLUSION: Our data suggest that in STEMI patients with patent IRA, optimal ST-segment resolution, and thrombus-containing lesion, deferred PCI when patients are given dual antiplatelet therapy, antithrombin agents, and GPIIb-IIIa inhibitors results in a higher procedural success rate, without an increased risk of MACE.

Prognostic value of albuminuria on 1-month mortality in acute myocardial infarction.

RATIONALE: An increase in albuminuria occurs in the early days after acute myocardial infarction. The aim of this study was to assess the relation between albuminuria and 30-day mortality, as well as its incremental predictive value, on top of established prognostic parameters. METHODS AND RESULTS: Demographic, clinical, and biological characteristics at admission, as well as in-hospital treatments and 1-month survival, were recorded in 1,211 consecutive patients admitted for acute myocardial infarction. Albuminuria was assessed from an 8-hour overnight urine collection within the first 2 days using immunonephelemetry. The population was categorized into 3 groups according to albuminuria levels (<20, 20-200, and >200 microg/min). Among survivors on day 2, 52% (625/1,211) of patients had an albuminuria level <20 microg/min, 39% (477) between 20 and 200 microg/min, and 9% (109) >200 microg/min. High levels of albuminuria were associated with older age, peripheral vessel disease, systolic blood pressure, glucose, creatinine, troponin, B-type natriuretic peptide, and high-sensitivity C reactive protein levels, as well as use of angiography, angiotensin-converting enzyme inhibitors, and beta blockers. At 1 month, there was a significantly higher mortality rate in groups with higher albuminuria. After adjustment for baseline characteristics, patients with albuminuria level of >20 microg/min had a 2.7-fold higher 30-day mortality, and those with >200 microg/min had an almost 4-fold higher 30-day mortality compared to those with albuminuria level of <20 microg/min. The addition of albuminuria information improved the discrimination capacity of the model and the global risk prediction. CONCLUSIONS: Albuminuria level, taken as a quantitative or categorical variable, is an independent and powerful predictor of mortality after acute myocardial infarction.

Management of unsuccessful thrombolysis in acute massive pulmonary embolism.

BACKGROUND: The management of patients with acute massive pulmonary embolism (PE) who do not respond to fibrinolytic therapy remains unclear. We aimed to compare rescue surgical embolectomy and repeat thrombolysis in patients who did not respond to thrombolysis. METHODS: We conducted a prospective single-center registry of PE patients who underwent thrombolytic therapy. Lack of response to thrombolysis within the first 36 h was prospectively defined as both persistent clinical instability and residual echocardiographic right ventricular dysfunction. Patients underwent surgical embolectomy or repeat thrombolysis, at the discretion of the attending physician. The clinical end point was a combined end point including recurrent PE, bleeding complications, or PE-related death, which was defined as death from recurrent PE or cardiogenic shock. Long-term adverse outcomes included death, recurrent thromboembolic events, and congestive heart failure. RESULTS: From January 1995 to January 2005, 488 PE patients underwent thrombolysis, of whom 40 (8.2%) did not respond to thrombolysis. Fourteen patients were treated by rescue surgical embolectomy, and 26 were treated by repeat thrombolysis. There was no significant difference in baseline characteristics between the two groups. The in-hospital course was uneventful in 11 of the surgically treated patients (79%) and in 8 patients (31%) treated by repeat thrombolysis (p = 0.004). There was a trend for higher mortality in the medical group than in the surgical group (10 vs 1 deaths, respectively; p = 0.07). There were significantly more recurrent PEs (fatal and nonfatal) in the repeat-thrombolysis group (35% vs 0%, respectively; p = 0.015). While no significant difference was observed in number of major bleeding events, all bleeding events in the repeat-thrombolysis group were fatal. The rate of uneventful long-term evolution was the same in the two groups. CONCLUSION: Rescue surgical embolectomy led to a better in-hospital course when compared with repeat thrombolysis in patients with massive PE who have not responded to thrombolysis. The transfer of patients who have not responded to thrombolysis to tertiary cardiac surgery centers could be considered as an alternative option.

Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients.

Home monitoring (HM) of cardioverter defibrillators (ICD) with its automated wireless remote data access, may decrease the rate of patient visits. This study examined the potential cost savings for the long-term care of ICD assisted by HM. A French database including 502 patients from 6 university hospitals was used. Costs of conventional follow-up (FU) of ICD were calculated without, and compared with the expected cost of FU with HM. Calculations included number of visits, including physician's fees, electrocardiograms, and specific ICD surveillance, and transportation costs. The mean distance between home and institutions performing follow-ups was 69 +/- 57 km. For each visit, a mean overall cost of 215 dollars was calculated, including 121 dollars for transportation and 94 dollars for medical services. HM may obviate up to 2 visits per year. Over the 5 years of expected life of the device, the decrease in costs for FU visits was estimated at 2,149 dollars. With an additional cost of 1,200 dollars for the HM system, saving began after a mean FU of 33.5 months. The time to onset of cost saving by HM ranged between 17.4 months for patients living >150 km from the medical facility to 52.2 months for those living <50 km away. It is concluded that the HM may considerably reduce the overall costs of ICD FU by saving on transportation cost, particularly when the distance between home and medical facility is >100 km.

Management of atrial tachyarrhythmias: benefits of pacemaker diagnostics.

The aim of this prospective multicenter study was to assess the clinical benefits of the Selection (Vitatron) pacemaker diagnostic functions (AF 1.0) in the management of AF. Forty patients (71 +/- 9 years of age), with documented AF and conventional pacing indications, received a Selection. The AF 1.0 function of the pacemaker was programmed to document the AF burden, onset, daily distribution, duration, premature atrial beats before onset, and mode of onset of the last 12 episodes for AF episodes exceeding 180 beats/min. By comparing patients' symptoms records, patient conventional assessment at follow-up and AF 1.0 data, the investigators evaluated the usefulness of AF 1.0 in AF management at 3- and 6-month follow-ups. Usefulness was defined as a change in arrhythmia management prompted by the disclosure of AF 1.0 data. AF recurrences were recorded in 71% of the follow-ups with symptoms reported by patients in only 16%. Thirty-nine percent of therapeutic changes based on conventional assessment were confirmed by AF 1.0 data, and in 61% of instances, the initial changes were modified by AF 1.0 data. Changes included pacing parameters in 56% of cases, AF prevention with pacing algorithms in 37%, and medical treatment in 7%. All investigators indicated that AF 1.0 was useful in all patients. The AF 1.0 diagnostic functions offered a unique documentation of AF in asymptomatic patients, and allowed therapeutic adjustments impossible otherwise.