Clinical Research in Cardiology最新文献

Aims: The MicraVR™ transcatheter pacing system (TPS) has been implemented into clinical routine for several years. The primary recipients are patients in need for VVI pacing due to bradycardia in the setting of atrial fibrillation (AF). Implantation safety and acute success have been proven in controlled studies and registries. So far only few long-term real-life data on TPS exist. We report indication, procedure and outcome data from two high-volume implanting German centers.

Methods: Between 2016 and 2019, 188 (of 303) patients were included. During follow-up (FU), TPS interrogation was performed after 4 weeks and thereafter every 6 months.

Results: Indication for TPS implantation in 159/188 (85%) patients was permanent or intermittent AV block III° in the setting of atrial fibrillation. The mean procedure duration was 50 min [35.0-70.0]. The average acute values after system release were: thresholds: 0.5V [0.38-0.74]/0.24ms; R-wave sensing: 10.0mV [8.1-13.5]; impedance: 650 Ohm [550-783]; RV-pacing demand: 16.9% [0.9-75.9]; and battery status: 3.15 V [3.12-3.16]. During FU of 723.4 ± 597.9 days, neither pacemaker failure nor infections were reported. Long-term FU revealed: thresholds: 0.5V [0.38-0.63]/0.24 ms; sensing: 12.3mV [8.9-17.2]; impedance: 570 Ohm [488-633]; RV-pacing demand: 87.1% [29.5-98.6]; and battery status 3.02 V [3.0-3.1]. Forty-three patients died from not-device-related causes.

Conclusion: This to date largest German long-term dataset for MicraVR™ TPS implantation revealed stable device parameter. Foremost, battery longevity seems to fulfill predicted values despite a significant increase in RV-pacing demand over time and even in patients with consecutive AV-node ablation. Of note, no infections or system failure were observed.

Background: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group.

Aim: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke.

Methods: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events.

Results: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS).

Conclusions: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients.

Clinicaltrials:

Gov identifier: NCT02230748.

Background: Randomized sham-controlled trials have confirmed the efficacy and safety of catheter-based renal denervation in hypertension. Data on the very long-term effects of renal denervation are scarce.

Aims: This study evaluates the 10-year safety and efficacy of renal denervation in resistant hypertension.

Methods: This prospective single-center study included patients with resistant hypertension undergoing radio-frequency renal denervation between 2010 and 2012. Office blood pressure, 24-h ambulatory blood pressure, antihypertensive medication, color duplex sonography, and renal function were assessed after 1-, 2- and 10-years.

Results: Thirty-nine patients completed the 10-year follow-up (mean follow-up duration 9.4 ± 0.7 years). Baseline office and 24-h ambulatory systolic blood pressure were 164 ± 23 mmHg and 153 ± 16 mmHg, respectively. After 10 years, 24-h ambulatory and office systolic blood pressure were reduced by 16 ± 17 mmHg (P < 0.001) and 14 ± 23 mmHg (P = 0.001), respectively. The number of antihypertensive drugs remained unchanged from 4.9 ± 1.4 to 4.5 ± 1.2 drugs (P = 0.087). The estimated glomerular filtration rate declined within the expected range from 69 (95% CI 63 to 74) to 60 mL/min/1.73m² (95% CI 53 to 68; P < 0.001) through 10-year follow-up. Three renal artery interventions were documented for progression of pre-existing renal artery stenosis in two patients and one patient with new-onset renal artery stenosis. No other adverse events were observed during the follow-up.

Conclusion: Renal denervation was safe and sustainedly reduced ambulatory and office blood pressure out to 10 years in patients with resistant hypertension.

Background: Device-related thrombus (DRT) after left atrial appendage occlusion (LAAO) is potentially linked to adverse events. Although clinical reports suggest an effect of the device type and position on the DRT risk, in-depth studies of its mechanistic basis are needed. This in silico study aimed to assess the impact of the position of non-pacifier (Watchman) and pacifier (Amulet) LAAO devices on surrogate markers of DRT risk.

Methods: The LAAO devices were modeled with precise geometry and virtually implanted in different positions into a patient-specific left atrium. Using computational fluid dynamics, the following values were quantified: residual blood, wall shear stress (WSS) and endothelial cell activation potential (ECAP).

Results: In comparison to an ostium-fitted device position, deep implantation led to more residual blood, lower average WSS and higher ECAP surrounding the device, especially on the device's atrial surface and the surrounding tissue, suggesting increased risk for potential thrombus. For the non-pacifier device, an off-axis device orientation resulted in even more residual blood, higher ECAP and similar average WSS as compared to an ostium-fitted device position. Overall, the pacifier device showed less residual blood, higher average WSS and lower ECAP, compared to the non-pacifier device.

Conclusions: In this in silico study, both LAAO device type and implant position showed an impact on potential markers of DRT in terms of blood stasis, platelet adhesion and endothelial dysfunction. Our results present a mechanistic basis for clinically observed risk factors of DRT and the proposed in silico model may aid in the optimization of device development and procedural aspects.

Background: Current guidelines recommend considering multiple factors while deciding between cardiac resynchronization therapy with a defibrillator (CRT-D) or a pacemaker (CRT-P). Nevertheless, it is still challenging to pinpoint those candidates who will benefit from choosing a CRT-D device in terms of survival.

Objective: We aimed to use topological data analysis (TDA) to identify phenogroups of CRT patients in whom CRT-D is associated with better survival than CRT-P.

Methods: We included 2603 patients who underwent CRT-D (54%) or CRT-P (46%) implantation at Semmelweis University between 2000 and 2018. The primary endpoint was all-cause mortality. We applied TDA to create a patient similarity network using 25 clinical features. Then, we identified multiple phenogroups in the generated network and compared the groups' clinical characteristics and survival.

Results: Five- and 10-year mortality were 43 (40-46)% and 71 (67-74)% in patients with CRT-D and 48 (45-50)% and 71 (68-74)% in those with CRT-P, respectively. TDA created a circular network in which we could delineate five phenogroups showing distinct patterns of clinical characteristics and outcomes. Three phenogroups (1, 2, and 3) included almost exclusively patients with non-ischemic etiology, whereas the other two phenogroups (4 and 5) predominantly comprised ischemic patients. Interestingly, only in phenogroups 2 and 5 were CRT-D associated with better survival than CRT-P (adjusted hazard ratio 0.61 [0.47-0.80], p < 0.001 and adjusted hazard ratio 0.84 [0.71-0.99], p = 0.033, respectively).

Conclusions: By simultaneously evaluating various clinical features, TDA may identify patients with either ischemic or non-ischemic etiology who will most likely benefit from the implantation of a CRT-D instead of a CRT-P.

Background: Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension.

Methods: The study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes.

Conclusions: This observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time.

Aim: Patients with rheumatoid arthritis (RA) have an increased risk of cardiac dysfunction and heart failure (HF) due to a pro-inflammatory state. Detecting cardiac dysfunction in RA is challenging as these patients often present preserved ejection fraction (EF) but may have subclinical ventricular dysfunction. Echocardiographic strain analysis is a promising tool for early detection of subclinical left ventricular systolic dysfunction (LVSD). This study assesses the prognostic role of strain analysis in RA.

Methods and results: Prospective study of 277 RA patients without known heart disease and preserved EF, categorized by left ventricular global longitudinal strain (GLS): normal GLS (≤ - 18%) vs. subclinical LVSD (> - 18%). Primary outcome was a composite of myocardial infarction, HF hospitalization, stroke, or cardiovascular death (MACE). Mean age was 57 years, 79% female. Although mean GLS was within normal (- 20 ± 3%), subclinical LVSD was observed in 24% of patients (n = 67) and was positively correlated with older age (OR 1.54 per 10 years; p < 0.001) and comorbid conditions, such as dyslipidemia (OR 2.27; p = 0.004), obesity (OR 2.29; p = 0.015), and chronic kidney disease (OR 8.39; p = 0.012). Subclinical LVSD was independently associated with a 3.9-fold higher risk of MACE (p = 0.003) and a 3.4-fold higher risk of HF hospitalization/cardiovascular death (p = 0.041). A GLS threshold of > - 18.5% provided optimal sensitivity (78%) and specificity (74%) in identifying patients at elevated MACE risk (AUC = 0.78; p < 0.001).

Conclusion: Subclinical LVSD, identified by reduced GLS, was strongly associated with adverse cardiovascular events in RA. Whether these findings have therapeutic implications is worth exploring in clinical trials.

Background: Impaired diastolic function is associated with a variety of diseases such as myocarditis or dilated cardiomyopathy. Currently, echocardiography is the standard method for assessing diastolic function. Recently, it has been postulated that cardiovascular magnetic resonance (CMR) is an at least equivalent or superior alternative to echocardiography. To assess CMR-based age- and gender-dependent diastolic functional normal reference values, pulmonary venous and transmitral blood-flow parameters were examined in heart-healthy test persons.

Methods and results: Flow-sensitive phase-contrast CMR imaging was performed in the right upper pulmonary vein (RUPV) and at the level of the mitral valve (MV) in 183 healthy subjects (age 10-70 years; 97 women, 86 men). The data was distributed as evenly as possible across all groups. Strong age-dependence was observed for PV S/D; r = 0.718, p < 0.001 (Pearson product-moment correlation) and for transmitral MV E/A; ρ = -0.736, p < 0.001 (Spearman's Rho correlation). Moderate age-dependence was found for PV slope D-wave; r = 0.394, p < 0.001. Except for MV slope E-wave (male -292 cm/s² interquartile range (IQR) {-338; -243} vs. female -319 ± 82 cm/s²; p = 0.047), no gender-related differences were observed. In a subgroup (N = 100), CMR data were compared with echocardiographic data. Strong correlation was found between CMR and echocardiography for PV S/D; r = 0.545, p < 0.001 and MV E/A; ρ = 0.692, p < 0.001.

Conclusion: Diastolic functional parameters change with age, while gender-differences are small. CMR and echocardiography showed similar PV S/D and MV E/A ratios, making CMR a promising alternative for assessing diastolic function.

Background and objective: Within recent years, transcatheter tricuspid edge-to-edge repair (T-TEER) has emerged as a safe and effective treatment option in patients with secondary tricuspid regurgitation (TR). However, for primary TR, data on the robustness and durability of TR reduction 1 year following T-TEER is limited.

Methods: All consecutive patients treated with T-TEER for TR at two high-volume centers between September 2018 and December 2022 were enrolled in a registry. Primary TR was defined as tricuspid valve (TV) prolapse or flail TV leaflets as assessed by pre- and peri-interventional transesophageal echocardiography (TEE).

Results: 201 patients were included in this analysis, of whom 27 (13.4%) were classified as primary TR and 174 (86.6%) as TR of secondary origin. All-cause mortality during 1-year follow-up was reached by 50 patients (24.9%) [primary: 7 (25.9%), secondary: 43 (24.7%)], and 151 (75.1%) completed follow-up with transthoracic echocardiography (TTE). Patients' median age was 80 (76-83) years, 112 (55.7%) were female and 181 (90.1%) reported a New-York heart association functional class (NYHA-FC) of III or IV. The remaining baseline clinical and echocardiographic parameters were comparable between the groups, but secondary TR patients had a significantly higher TRI-SCORE (5 (4-8) vs. 7 (5-14), P = 0.010). In both groups, an immediate reduction of TR-Grade post-intervention was observed. This reduction was sustained at follow-up with 80.0% of the primary TR patients classified as moderate or less and 61.8% of the secondary TR patients. This translated to a significant improvement of NHYA-FC in both groups. Kaplan-Meier analysis revealed no differences regarding rates for all-cause mortality between the groups (P < 0.99).

Conclusion: T-TEER achieves a robust TR reduction in primary TR patients 1 year after intervention with noninferior clinical results to treatment for secondary TR with regards to mortality, re-hospitalization, and NYHA-FC.