Employment of the Evolution RL sheath as a first-choice device shortens transvenous lead extraction time without affecting procedural safety and efficacy compared to its auxiliary use: Insights from the prospective multicenter EVO registry.

BACKGROUND: Transvenous lead extraction (TLE) is recommended in cases of local and systemic infections related to cardiac implantable electronic devices (CIEDs). Additionally, TLE is indicated in the event of lead damage or CIED malfunction. The extraction procedure is associated with a risk of life-threatening complications. OBJECTIVES: The aim of the EVO registry was to assess the safety and efficacy of birotational Evolution tool usage. MATERIAL AND METHODS: This registry study was prospectively conducted in 8 high-volume implantation centers in Poland. The study included 133 patients aged 63.5 ±15.1 years, and 76.69% were male. Indications for the procedure were: local or systemic infection (33.1%) and lead dysfunction (66.9%). The number of leads extracted varied from 1 (39.84%) to 3 (9.77%). RESULTS: Clinical procedural success was achieved in 99.1% of cases. A total of 226 leads were extracted, and 206 used the Evolution system. Two procedural strategies were identified while using the Evolution system: (1) usage of locking stylet, propylene sheaths and the Evolution system (118 leads, 52%) - group A; (2) usage of locking stylet and Evolution (88 leads, 39%) - group B. There were no differences in the number of complications between these 2 groups. The extraction time was significantly shorter (p = 0.02) in group B than in group A. Major complications occurred in 5.2% of cases with 2 intraprocedural deaths. Minor complications occurred in 1.5% of patients. CONCLUSIONS: The registry confirmed the efficacy and relative safety of the birotational Evolution sheath. Using the rotational sheath as a first attempt significantly reduces extraction time without compromising its safety.

The Use of Machine Learning Algorithms in the Evaluation of the Effectiveness of Resynchronization Therapy.

BACKGROUND: Cardiovascular disease remains the leading cause of death in the European Union and worldwide. Constant improvement in cardiac care is leading to an increased number of patients with heart failure, which is a challenging condition in terms of clinical management. Cardiac resynchronization therapy is becoming more popular because of its grounded position in guidelines and clinical practice. However, some patients do not respond to treatment as expected. One way of assessing cardiac resynchronization therapy is with ECG analysis. Artificial intelligence is increasing in terms of everyday usability due to the possibility of everyday workflow improvement and, as a result, shortens the time required for diagnosis. A special area of artificial intelligence is machine learning. AI algorithms learn on their own based on implemented data. The aim of this study was to evaluate using artificial intelligence algorithms for detecting inadequate resynchronization therapy. METHODS: A total of 1241 ECG tracings were collected from 547 cardiac department patients. All ECG signals were analyzed by three independent cardiologists. Every signal event (QRS-complex) and rhythm was manually classified by the medical team and fully reviewed by additional cardiologists. The results were divided into two parts: 80% of the results were used to train the algorithm, and 20% were used for the test (Cardiomatics, Cracow, Poland). RESULTS: The required level of detection sensitivity of effective cardiac resynchronization therapy stimulation was achieved: 99.2% with a precision of 92.4%. CONCLUSIONS: Artificial intelligence algorithms can be a useful tool in assessing the effectiveness of resynchronization therapy.

Kardia Mobile applicability in clinical practice: A comparison of Kardia Mobile and standard 12-lead electrocardiogram records in 100 consecutive patients of a tertiary cardiovascular care center.

BACKGROUND: Mobile devices are gaining a rising number of users in all countries around the globe. Novel solutions to diagnose patients with out-of-hospital onset of arrhythmic symptoms can be easily used to record such events, but the effectiveness of these devices remain unknown. METHODS: In a group of 100 consecutive patients of an academic cardiology care center (mean age 68 ± 14.2 years, males: 66%) a standard 12-lead electrocardiogram (ECG) and a Kardia Mobile (KM) record were registered. Both versions were assessed by three independant groups of physicians. RESULTS: The analysis of comparisons for standard ECG and KM records showed that the latter is of lower quality (p < 0.001). It was non-inferior for detection of atrial fibrillation and atrial flutter, showed weaker rhythm detection in pacemaker stimulation (p = 0.008), and was superior in sinus rhythm detection (p = 0.02), though. The sensitivity of KM to detect pathological Q-wave was low compared to specificity (20.6% vs. 93.7%, respectively, p < 0.001). Basic intervals measured by the KM device, namely PQ, RR, and QT were significantly different (shorter) than those observed in the standard ECG method (160 ms vs. 180 ms [p < 0.001], 853 ms vs. 880 ms [p = 0.03] and 393 ms vs. 400 ms [p < 0.001], respectively). CONCLUSIONS: Initial and indicative value of atrial fibrillation and atrial flutter detection in KM is comparable to results achieved in standard ECG. KM was superior in detection of sinus rhythm than eye-ball evaluation of 12-lead ECG. Though, the PQ and QT intervals were shorter in KM as compared to 12-lead ECG. Clinical value needs to be verified in large studies, though.

Feasibility and safety of augmented-reality glass for computed tomography-assisted percutaneous revascularization of coronary chronic total occlusion: A single center prospective pilot study.

BACKGROUND: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) may be facilitated by projection of coronary computed tomography angiography (CTA) datasets in the catheterization laboratory. There is no data on the feasibility and safety outcomes of CTA-assisted CTO PCI using a wearable augmented-reality glass. METHODS: A total of 15 patients scheduled for elective antegrade CTO intervention were prospectively enrolled and underwent preprocedural coronary CTA. Three-dimensional and curved multiplanar CT reconstructions were transmitted to a head-mounted hands-free computer worn by interventional cardiologists during CTO PCI to provide additional information on CTO tortuosity and calcification. The results of CTO PCI using a wearable computer were compared with a time-matched prospective angiographic registry of 59 patients undergoing antegrade CTO PCI without a wearable computer. Operators' satisfaction was assessed by a 5-point Likert scale. RESULTS: Mean age was 64 ± 8 years and the mean J-CTO score was 2.1 ± 0.9 in the CTA-assisted group. The voice-activated co-registration and review of CTA images in a wearable computer during CTO PCI were feasible and highly rated by PCI operators (4.7/5 points). There were no major adverse cardiovascular events. Compared with standard CTO PCI, CTA-assisted recanalization of CTO using a wearable computer showed more frequent selection of the first-choice stiff wire (0% vs 40%, p < 0.001) and lower contrast exposure (166 ± 52 vs 134 ± 43 ml, p = 0.03). Overall CTO success rates and safety outcomes remained similar between both groups. CONCLUSIONS: CTA-assisted CTO PCI using an augmented-reality glass is feasible and safe, and might reduce the resources required for the interventional treatment of CTO.

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study.

BACKGROUND: Over the last several years significant rises in the use of implanted cardioverter-defibrillators (ICD) have also resulted in a number of associated complications. This number includes lead failure. Sprint Fidelis (SF) ICD lead is regarded as a lead with elevated failure risk. Every center acting in accordance with the guidelines should observe patients more thoroughly especially with recalled leads and run a registry of their follow-up. The aim of this research was to present follow-up of the patients with SF leads (types 6948, 6949) from a single implantation center. METHODS: There were 36 SF leads implanted in 36 patients. Mean follow-up period was 76 months (IQR 40.3-86.8). Patients were subjected to regular check-ups in 3 to 6 month intervals. RESULTS: Patients were implanted at a median age of 66.5 years and majority of them had ischemic cardiomyopathy (72%). A majority of the studied population were men (72.2%). Predominantly dual-chamber ICD (ICD-DR) were implanted (50% ICD-DR vs. 47.2% ICD-VR). The guidelines for management of patients implanted with SF were fully implemented. During the follow-up 14 (38.9%) patients died. No deaths were noted that could be attributed to lead failure. In 5 cases lead failure was identified and of these 4 leads were replaced. Median time from implantation to the detection of lead dysfunction was 52 months (IQR 49; 83). The symptoms of failure consisted of: inappropriate shocks, alternating ventricular lead signal, or loss of ventricular stimulation. CONCLUSIONS: The follow-up of patients with recalled SF leads in a single center supports that implementation SF management guidelines could be effective in clinical practice.