• MeSH
• blokáda Tawarova raménka etiologie   terapie   MeSH
• elektrokardiografie MeSH
• funkce levé komory srdeční MeSH
• Hisův svazek * MeSH
• kardiomyopatie * etiologie   terapie   MeSH
• kardiostimulace umělá škodlivé účinky   MeSH
• lidé MeSH
• srdeční komory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

• MeSH
• atrioventrikulární blokáda terapie   MeSH
• fibrilace síní terapie   etiologie   MeSH
• kardiostimulace umělá * škodlivé účinky   metody   MeSH
• kardiostimulátor * škodlivé účinky   MeSH
• lidé MeSH
• následné studie MeSH
• prospektivní studie MeSH
• srdeční arytmie * terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinická studie MeSH
• multicentrická studie MeSH

OBJECTIVE: The onset of new conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is still a relevant adverse event. The main objective of this registry was to identify modifiable procedural risk factors for an improved outcome (lower rate of PPI) after TAVI in patients at high risk of PPI. METHODS: Patients from four European centres receiving a balloon-expandable TAVI (Edwards SAPIEN 3/3 Ultra) and considered at high risk of PPI (pre-existing conduction disturbance, heavily calcified left ventricular outflow tract or short membranous septum) were prospectively enrolled into registry. RESULTS: A total of 300 patients were included: 42 (14.0%) required PPI after TAVI and 258 (86.0%) did not. Patients with PPI had a longer intensive care unit plus intermediate care stay (65.7 vs 16.3 hours, p<0.001), general ward care stay (6.9 vs 5.3 days, p=0.004) and later discharge (8.6 vs 5.0 days, p<0.001). Of the baseline variables, only pre-existing right bundle branch block at baseline (OR 6.8, 95% CI 2.5 to 18.1) was significantly associated with PPI in the multivariable analysis. Among procedure-related variables, oversizing had the highest impact on the rate of PPI: higher than manufacturer-recommended sizing, mean area oversizing as well as the use of the 29 mm valve (OR 3.4, 95% CI 1.4 to 8.5, p=0.008) all were significantly associated with PPI. Rates were higher with the SAPIEN 3 (16.1%) vs SAPIEN 3 Ultra (8.5%), although not statistically significant but potentially associated with valve sizing. Implantation depth and postdelivery balloon dilatation also tended to affect PPI rates but without a statistical significance. CONCLUSION: Valve oversizing is a strong procedure-related risk factor for PPI following TAVI. The clinical impact of the valve type (SAPIEN 3), implantation depth, and postdelivery balloon dilatation did not reach significance and may reflect already refined procedures in the participating centres, giving attention to these avoidable risk factors. TRIAL REGISTRATION NUMBER: NCT03497611.

• MeSH
• aortální stenóza * chirurgie   MeSH
• kardiostimulace umělá škodlivé účinky   metody   MeSH
• kardiostimulátor * MeSH
• lidé MeSH
• registrace MeSH
• rizikové faktory MeSH
• srdeční chlopně umělé * škodlivé účinky   MeSH
• transkatetrální implantace aortální chlopně * škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• práce podpořená grantem MeSH

BACKGROUND: Right ventricular pacing (RVP) can result in pacing-induced cardiomyopathy (PICM). It is unknown whether specific biomarkers reflect differences between His bundle pacing (HBP) and RVP and predict a decrease in left ventricular function during RVP. AIMS: We aimed to compare the effect of HBP and RVP on the left ventricular ejection fraction (LVEF) and to study how they affect serum markers of collagen metabolism. METHODS: Ninety-two high-risk PICM patients were randomized to HBP or RVP groups. Their clinical characteristics, echocardiography, and serum levels of transforming growth factor β1 (TGF-β1), matrix metalloproteinase 9 (MMP-9), suppression of tumorigenicity 2 interleukin (ST2-IL), tissue inhibitor of metalloproteinase 1 (TIMP-1), and galectin 3 (Gal-3) were studied before pacemaker implantation and six months later. RESULTS: Fifty-three patients were randomized to the HBP group and 39 patients to the RVP group. HBP failed in 10 patients, who crossed over to the RVP group. Patients with RVP had significantly lower LVEF compared to HBP patients after six months of pacing (-5% and -4% in as-treated and intention-to-treat analysis, respectively). Levels of TGF-β1 after 6 months were lower in HBP than RVP patients (mean difference -6 ng/ml; P = 0.009) and preimplant Gal-3 and ST2-IL levels were higher in RVP patients, with a decline in LVEF ≥5% compared to those with a decline of <5% (mean difference 3 ng/ml and 8 ng/ml; P = 0.02 for both groups). CONCLUSION: In high-risk PICM patients, HBP was superior to RVP in providing more physiological ventricular function, as reflected by higher LVEF and lower levels of TGF-β1. In RVP patients, LVEF declined more in those with higher baseline Gal-3 and ST2-IL levels than in those with lower levels.

• MeSH
• biologické markery MeSH
• elektrokardiografie MeSH
• funkce levé komory srdeční * fyziologie   MeSH
• Hisův svazek MeSH
• interleukin-1 receptor-like 1 protein MeSH
• kardiomyopatie * MeSH
• kardiostimulace umělá škodlivé účinky   MeSH
• kolagen MeSH
• lidé MeSH
• tepový objem fyziologie   MeSH
• tkáňový inhibitor metaloproteinasy 1 MeSH
• transformující růstový faktor beta1 MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: Left bundle branch area pacing (LBBAP) is an emerging technique to achieve cardiac resynchronization therapy (CRT), but its feasibility and safety in elderly patients with heart failure with reduced ejection fraction and left bundle branch block is hardly investigated. METHODS: We enrolled consecutive patients with an indication for CRT comparing pacing parameters and complication rates of LBBAP-CRT in elderly patients (≥ 75 years) versus younger patients (< 75 years) over a 6-month follow-up. RESULTS: LBBAP was successful in 55/60 enrolled patients (92%), among which 25(45%) were elderly. In both groups, LBBAP significantly reduced the QRS duration (elderly group: 168 ± 15 ms to 136 ± 12 ms, p < 0.0001; younger group: 166 ± 14 ms to 134 ± 11 ms, p < 0.0001) and improved LVEF (elderly group: 28 ± 5% to 40 ± 7%, p < 0.0001; younger group: 29 ± 5% to 41 ± 8%, p < 0.0001). The pacing threshold was 0.9 ± 0.8 V in the elderly group vs. 0.7 ± 0.5 V in the younger group (p = 0.350). The R wave was 9.5 ± 3.9 mV in elderly patients vs. 10.7 ± 2.7 mV in younger patients (p = 0.341). The fluoroscopic (elderly: 13 ± 7 min vs. younger: 11 ± 7 min, p = 0.153) and procedural time (elderly: 80 ± 20 min vs. younger: 78 ± 16 min, p = 0.749) were comparable between groups. Lead dislodgement occurred in 2(4%) patients, 1 in each group (p = 1.000). Intraprocedural septal perforation occurred in three patients (5%), 2(8%) in the elderly group (p = 0.585). One patient (2%) in the elderly group had a pocket infection. CONCLUSIONS: LBBAP is a feasible and safe technique for delivering physiological pacing in elderly patients who are candidates for CRT with suitable pacing parameters and low complication rates.

• MeSH
• elektrokardiografie metody   MeSH
• Hisův svazek MeSH
• kardiostimulace umělá škodlivé účinky   metody   MeSH
• lidé MeSH
• senioři MeSH
• srdeční resynchronizační terapie * metody   MeSH
• studie proveditelnosti MeSH
• tepový objem MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH

Na naše oddělení byla přijata 64letá žena k implantaci dvoudutinového kardiostimulátoru. Samotný výkon se obešel bez jakékoli komplikace. Jedna komorová elektroda s aktivní fixací byla umístěna v hrotu pravé komory. Brzy po implantaci začal pacientku sužovat neproduktivní kašel, jednoznačně související s komorovou stimulací. Transtorakální echokardiografie prokázala malý perikardiální výpotek podél apikálních segmentů. U pacientky bylo provedeno urgentní CT vyšetření s kontrastní látkou, které potvrdilo perikardiální výpotek a přítomnost elektrody v myokardu hrotu pravé komory. Pro přetrvávání symptomů jsme se rozhodli přemístit pravokomorovou elektrodu do středu mezikomorového septa. Po výkonu kašel okamžitě vymizel.

A 64-year-old woman was admitted to our department for dual-chamber pacemaker implantation. No complication apparently occurred during the procedure. An active fixation ventricular lead was positioned in right ventricular septal apex. Soon after implantation the patient started to suffer from non-productive cough, clearly related to ventricular stimulation. Transthoracic echocardiography revealed a small pericardial effusion along the apical segments. The patient underwent urgent contrast chest CT confirming pericardial effusion, and showing an intramyocardium placement of the right ventricular apical lead. Due to persistence of symptoms, we decided to perform right ventricular lead repositioning in right middle septum. Post-procedure, cough abruptly disappeared.

• Klíčová slova
• Cough, Lead perforation, Pacemaker implantation, Tamponade, Implantace kardiostimulátoru, Kašel, Perforace srdce elektrodou, Tamponáda, perforace srdce elektrodou,
• MeSH
• kardiostimulace umělá škodlivé účinky   MeSH
• kardiostimulátor * škodlivé účinky   MeSH
• kašel etiologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• srdeční tamponáda * etiologie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• kazuistiky MeSH

AIMS: Permanent transseptal left bundle branch area pacing (LBBAP) is a promising new pacing method for both bradyarrhythmia and heart failure indications. However, data regarding safety, feasibility and capture type are limited to relatively small, usually single centre studies. In this large multicentre international collaboration, outcomes of LBBAP were evaluated. METHODS AND RESULTS: This is a registry-based observational study that included patients in whom LBBAP device implantation was attempted at 14 European centres, for any indication. The study comprised 2533 patients (mean age 73.9 years, female 57.6%, heart failure 27.5%). LBBAP lead implantation success rate for bradyarrhythmia and heart failure indications was 92.4% and 82.2%, respectively. The learning curve was steepest for the initial 110 cases and plateaued after 250 cases. Independent predictors of LBBAP lead implantation failure were heart failure, broad baseline QRS and left ventricular end-diastolic diameter. The predominant LBBAP capture type was left bundle fascicular capture (69.5%), followed by left ventricular septal capture (21.5%) and proximal left bundle branch capture (9%). Capture threshold (0.77 V) and sensing (10.6 mV) were stable during mean follow-up of 6.4 months. The complication rate was 11.7%. Complications specific to the ventricular transseptal route of the pacing lead occurred in 209 patients (8.3%). CONCLUSIONS: LBBAP is feasible as a primary pacing technique for both bradyarrhythmia and heart failure indications. Success rate in heart failure patients and safety need to be improved. For wider use of LBBAP, randomized trials are necessary to assess clinical outcomes.

• MeSH
• blokáda Tawarova raménka terapie   etiologie   MeSH
• bradykardie terapie   etiologie   MeSH
• elektrokardiografie metody   MeSH
• Hisův svazek * MeSH
• kardiostimulace umělá škodlivé účinky   metody   MeSH
• lidé MeSH
• senioři MeSH
• srdeční selhání * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (P=0.012). There were no Moderato device- or CNT-related adverse events. Conclusions CNT significantly reduced 24-hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02837445.

• MeSH
• časové faktory MeSH
• dvojitá slepá metoda MeSH
• funkce levé komory srdeční MeSH
• hypertenze diagnóza   patofyziologie   terapie   MeSH
• kardiostimulace umělá * škodlivé účinky   MeSH
• kardiostimulátor * MeSH
• krevní tlak * MeSH
• lidé MeSH
• pilotní projekty MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• srdce inervace   MeSH
• srdeční frekvence * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa MeSH

BACKGROUND: Morbidity and mortality outcomes for patients admitted for acute decompensated heart failure are poor and have not significantly changed in decades. Current therapies are focused on symptom relief by addressing signs and symptoms of congestion. The objective of this study was to test a novel neuromodulation therapy of stimulation of epicardial cardiac nerves passing along the posterior surface of the right pulmonary artery. METHODS: Fifteen subjects admitted for defibrillator implantation and ejection fraction ≤35% on standard heart failure medications were enrolled. Through femoral arterial access, high fidelity pressure catheters were placed in the left ventricle and aortic root. After electro anatomic rendering of the pulmonary artery and branches, either a circular or basket electrophysiology catheter was placed in the right pulmonary artery to allow electrical intravascular stimulation at 20 Hz, 4 ms pulse width, and ≤20 mA. Changes in maximum positive dP/dt (dP/dtMax) indicated changes in ventricular contractility. RESULTS: Of 15 enrolled subjects, 5 were not studied due to equipment failure or abnormal pulmonary arterial anatomy. In the remaining subjects, dP/dtMax increased significantly by 22.6%. There was also a significant increase in maximum negative dP/dt (dP/dtMin), mean arterial pressure, systolic pressure, diastolic pressure, and left ventricular systolic pressure. There was no significant change in heart rate or left ventricular diastolic pressure. CONCLUSIONS: In this first-in-human study, we demonstrated that in humans with stable heart failure, left ventricular contractility could be accentuated without an increase in heart rate or left ventricular filling pressures. This benign increase in contractility may benefit patients admitted for acute decompensated heart failure.

• MeSH
• autonomní nervový systém patofyziologie   MeSH
• časové faktory MeSH
• funkce levé komory srdeční * MeSH
• kardiostimulace umělá škodlivé účinky   metody   MeSH
• kontrakce myokardu * MeSH
• lidé středního věku MeSH
• lidé MeSH
• obnova funkce MeSH
• ověření koncepční studie MeSH
• senioři MeSH
• srdce inervace   MeSH
• srdeční selhání diagnóza   patofyziologie   terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

OBJECTIVES: The ASD2 (Acute Extravascular Defibrillation, Pacing, and Electrogram) study evaluated the ability to adequately sense, pace, and defibrillate patients with a novel implantable cardioverter-defibrillator (ICD) lead implanted in the substernal space. BACKGROUND: Subcutaneous ICDs are an alternative to a transvenous defibrillator system when transvenous implantation is not possible or desired. An alternative extravascular system placing a lead under the sternum has the potential to reduce defibrillation energy and the ability to deliver pacing therapies. METHODS: An investigational lead was inserted into the substernal space via a minimally invasive subxiphoid access, and a cutaneous defibrillation patch or subcutaneous active can emulator was placed on the left mid-axillary line. Pacing thresholds and extracardiac stimulation were evaluated. Up to 2 episodes of ventricular fibrillation were induced to test defibrillation efficacy. RESULTS: The substernal lead was implanted in 79 patients, with a median implantation time of 12.0 ± 9.0 min. Ventricular pacing was successful in at least 1 vector in 76 of 78 patients (97.4%), and 72 of 78 (92.3%) patients had capture in ≥1 vector with no extracardiac stimulation. A 30-J shock successfully terminated 104 of 128 episodes (81.3%) of ventricular fibrillation in 69 patients. There were 7 adverse events in 6 patients causally (n = 5) or possibly (n = 2) related to the ASD2 procedure. CONCLUSIONS: The ASD2 study demonstrated the ability to pace, sense, and defibrillate using a lead designed specifically for the substernal space.

• MeSH
• defibrilátory implantabilní * škodlivé účinky   statistika a číselné údaje   MeSH
• elektrokardiografie MeSH
• implantace protézy škodlivé účinky   metody   mortalita   statistika a číselné údaje   MeSH
• kardiostimulace umělá * škodlivé účinky   statistika a číselné údaje   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mediastinum chirurgie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční arytmie terapie   MeSH
• sternum chirurgie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinická studie MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH