Effects of complete revascularization according to age in patients with ST-segment elevation myocardial infarction and multivessel disease (COMPLETE-AGE).

BACKGROUND: In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS: COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS: Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS: In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.

Transfemoral-only transcatheter aortic valve replacement: A single center experience of 400 consecutive patients.

BACKGROUND: In transcatheter aortic valve replacement (TAVR), transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies. AIMS: Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate. METHODS: Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expanding and balloon-expandable stents, and intravascular lithotripsy (IVL). RESULTS: A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TF access (35.8% vs. 3.4%, p < 0.001). CONCLUSION: Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high.

Cerebral embolic protection during transcatheter aortic valve replacement: Insights from a consecutive series with the Sentinel cerebral protection device.

BACKGROUND: Growing interest in neuroprotection in transcatheter aortic valve replacement (TAVR) has catalyzed the development of cerebral protection systems (CPS). OBJECTIVES: Report insights from consecutive real-world patients undergoing TAVR with the Sentinel-CPS. METHODS: Patients with severe aortic stenosis undergoing TAVR from April 2019 to May 2022 were enrolled in a prospective registry. The reason for unsuccessful Sentinel-CPS deployment and the amount of debris captured by the filters were prospectively recorded. RESULTS: The Sentinal CPS was successfully deployed in 330 patients (85%, Group 1). Deployment was not attempted, unsuccessful or only partially successful in 59 patients (15%, Group 2), caused by anatomical factors such as tortuosity, heavy calcification or small dimensions of radial or brachial artery in 46, technical aspects such as puncture failure or dissection in 5 or use of right radial access for the pigtail in 6. Debris was captured in 98% of patients in Group 1. In 40%, the amount of debris was graded moderate or extensive. Predictors for moderate/extensive debris were moderate/severe aortic calcification (OR 1.50, CI 1.05-2.15, p = 0.03), pre- and postdilatation (OR 1.97, CI 1.02-3.79, p = 0.04 and OR 1.71, CI 1.01-2.89, p = 0.048). The risk of stroke was numerically lower in patients who underwent TAVR with the Sentinel CPS (2.1 vs. 5.1%, respectively, p = 0.15). There was no stroke during CPS deployment, but one patient had a stroke immediately after device retrieval. CONCLUSIONS: The Sentinel-CPS was successfully deployed in 85% of patients. Predictors for moderate/extensive debris captured were moderate/severe aortic calcification, pre- and postdilatation.

Right Heart Structure and Function after Electrical Cardioversion for Atrial Fibrillation.

INTRODUCTION: Atrial fibrillation (AF) adversely impacts right ventricular (RV) and right atrial (RA) structure and function. There are limited data on these changes after electrical cardioversion (ECV) and the relative contribution of heart rate to evaluate the immediate (1-2 h) and short-term (4-6 weeks) changes in right cardiac chamber dimensions and RV function after ECV in patients with persistent AF. METHODS: Right cardiac chamber dimensions and RV function were measured in 64 patients using transthoracic echocardiography 1-2 h before, immediately after, and 4-6 weeks after ECV. Associations between changes in right-heart measures and rhythm status at follow-up were assessed using linear regression models. RESULTS: For patients who remained in sinus rhythm 4-6 weeks after ECV (n = 48), median fractional area change (FAC) at baseline, immediately after ECV, and 4-6 weeks after ECV were 39 (Q1:35, Q3:42) %, 42 (Q1:39, Q3:46) %, 46 (Q1:43, Q3:49) % (p < 0.01); median tricuspid annular plane systolic excursion (TAPSE) values at the same time points were 18 (Q1:17, Q3:20) mm, 20 (Q1:18, Q3:23) mm, and 24 (Q1:22, Q3:26) mm (p < 0.01), respectively. There was no significant difference in RV end systolic area and RA volume index before and after ECV. However, RV end systolic area and RA volume index decreased significantly after 4-6 weeks from a median of 10 (Q1:8, Q3:13) cm2 to 8 (Q1:7, Q3:10) cm2 (p < 0.01), and from a median of 30 (Q1:24, Q3:36) mL/m2 to 24 (Q1:20, Q3:27) mL/m2 (p < 0.01). Changes in TAPSE were significantly associated with sinus rhythm at follow-up (p = 0.027), changes in FAC showed a strong trend to association with sinus rhythm (p = 0.053), and this was not true for RA measures (p = 0.64). CONCLUSIONS: Among AF patients who remained in sinus rhythm after ECV, RV function improved immediately after ECV with further improvement at 4-6 weeks following sinus rhythm restoration.

Mitigating the risk of flow deterioration by deferring stent optimization in STEMI patients with large thrombus burden: Insights from a prospective cohort study.

OBJECTIVES: It is uncertain, if omitting post-dilatation and stent oversizing (stent optimization) is safe and may decrease the risk for distal thrombus embolization (DTE) in STEMI patients with large thrombus burden (LTB). BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) with stenting, (DTE) and flow deterioration are common and increase infarct size leading to worse outcomes. METHODS: From a prospective registry, 74 consecutive STEMI patients with LTB undergoing pPCI with stenting and intentionally deferred stent optimization were analyzed. Imaging data and outcomes up to 2 years follow-up were analyzed. RESULTS: Overall, 74 patients (18% females) underwent deferred stent optimization. Direct stenting was performed in 13 (18%) patients. No major complications occurred during pPCI. Staged stent optimization was performed after a median of 4 (interquartile range (IQR) 3; 7) days. On optical coherence tomography, under-expansion and residual thrombus were present in 59 (80%) and 27 (36%) cases, respectively. During deferred stent optimization, we encountered no case of flow deterioration (slow or no-reflow) or side branch occlusion. Minimal lumen area (mm2) and stent expansion (%) were corrected from 4.87±1.86mm to 6.82±2.36mm (p<0.05) and from 69±18% to 91±12% (p<0.001), respectively. During follow-up, 1 patient (1.4%) required target lesion revascularization and 1 (1.4%) patient succumbed from cardiovascular death. CONCLUSIONS: Among STEMI patients with LTB, deferring stent optimization in the setting of pPCI appears safe and potentially mitigates the risk of DTE. The impact of this approach on infarct size and clinical outcomes warrants further investigation in a dedicated trial.

The relevance of tricuspid regurgitation in patients undergoing percutaneous treatment of mitral regurgitation.

OBJECTIVES: Investigate the impact of concomitant tricuspid regurgitation (TR) on clinical outcomes during long-term follow-up in patients undergoing percutaneous treatment of mitral regurgitation (MR) with the MitraClip system. BACKGROUND: Patients undergoing mitral repair using the MitraClip frequently present with concomitant TR. It is uncertain how the presence of TR impacts the long-term outcomes of such patients. METHODS: We analyzed consecutive patients with MitraClip implantation from the prospective MitraSwiss registry. Endpoints were all-cause mortality, hospitalization for heart failure, and the composite endpoint of the two. RESULTS: We enrolled 177 patients (mean age 76 ± 9 years, 37% female). Acute procedural success was achieved in 149 (84%). Concomitant moderate or severe TR was present in 31% at baseline and 32% before discharge. After a median follow-up of 1103 days (IQR: 555-1766 days), 70 (40%) of patients had died, and 34 (19%) were hospitalized for heart failure. In multivariable analysis, TR at baseline was associated with an increase in all-cause mortality (HR: 2.34, 95% CI: 1.36-4.03, p < 0.01), hospitalization for heart failure (HR: 3.19, 95% CI: 1.37-7.41, p = 0.01), and the composite endpoint (HR: 2.00, 95% CI: 1.19-3.36, p = 0.01). CONCLUSION: Despite treatment of MR, TR did not improve in most patients. The presence of relevant TR at baseline was associated with reduced survival and higher rates of hospitalization for heart failure. More research is needed to understand the causal role of TR in such patients and to investigate if simultaneous treatment of concomitant TR may improve prognosis in patients undergoing percutaneous treatment of MR.

Mechanical versus bioprosthetic valves in chronic dialysis: a systematic review and meta-analysis.

BACKGROUND: Many patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We performed a systematic review and meta-analysis to assess outcomes of patients with dialysis-dependent ESKD who received mechanical or bioprosthetic valves. METHODS: We searched Cochrane Central, Medline and Embase from inception to January 2020. We performed screening, full-text assessment, risk of bias and data collection, independently and in duplicate. Data were pooled using a random-effects model. RESULTS: We identified 28 observational studies (n = 9857 patients, including 6680 with mechanical valves and 3717 with bioprosthetic valves) with a median follow-up of 3.45 years. Twenty-two studies were at high risk of bias and 1 was at critical risk of bias from confounding. Certainty in evidence was very low for all outcomes except bleeding. Mechanical valves were associated with reduced mortality at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI] 0.65-0.97, I 2 = 0, absolute effect 27 fewer deaths per 1000) and at 6 or more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, I 2 = 79%, absolute effect 145 fewer deaths per 1000), but increased bleeding (incidence rate ratio [IRR] 2.46, 95% CI 1.41-4.27, I 2 = 59%, absolute effect 91 more events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, I 2 = 0%, absolute effect 25 more events per 1000). CONCLUSION: Mechanical valves were associated with reduced mortality, but increased rate of bleeding and stroke. Given very low certainty for evidence of mortality and stroke outcomes, patients and clinicians may choose prosthetic valves based on factors such as bleeding risk and valve longevity. STUDY REGISTRATION: PROSPERO no. CRD42017081863.

Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

OBJECTIVES: Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms. BACKGROUND: The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD). METHODS: We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100). RESULTS: The initial cohort (n = 100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n = 100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p = .03, as well as a reduction in MANTA-related bleeding complications to 5% p = .01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far. CONCLUSIONS: Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Mineralocorticoid receptor antagonists in patients with acute myocardial infarction - A systematic review and meta-analysis of randomized trials.

BACKGROUND: Although mineralocorticoid antagonists (MRAs) reduce mortality in patients with heart failure complicating myocardial infarction (MI), it is unclear if they could be beneficial to all patients with MI. To evaluate the utility of MRAs in MI patients, we performed a systematic review and meta-analysis. METHODS: MEDLINE, EMBASE, and Cochrane CENTRAL were searched from 1965 to June 2016. Conference abstracts were searched from 2000 to June 2016. Randomized trials evaluating the effect of MRA after MIs were included. Two reviewers independently extracted data and assessed study quality. Data were combined using fixed-/random-effects models. RESULTS: Eleven randomized clinical trials (N = 11,258) were included; 1 trial (N = 6,642) included patients with apparent heart failure (Killip class III-IV). Administration of MRA versus placebo or standard therapy (no-MRA) after MI reduced overall and cardiovascular mortality (odds ratio [OR] 0.82, 95% CI 0.73-0.93, P = .002, and OR 0.82, 95% CI 0.71-0.93, P = .003, respectively; I2 for both = 0%). In the subgroup of trials with patients with heart failure, the mortality was 14.4% in MRA group versus 16.7% in no-MRA group (OR 0.84, 95% CI 0.73-0.96), and among those without heart failure, it was 2.5% with MRA versus 3.5% without MRA (OR 0.72, 95% CI 0.51-1.02, P for interaction = .43). Patients receiving MRA had fewer new or worsening heart failure events (OR 0.74, 95% CI 0.66-0.84, P < .0001; I2 = 14%). Nevertheless, MRA therapy increased risk for hyperkalemia (≥5.5 mmol/L) (OR 2.52, 95% CI 1.36-4.65, P = .003; I2 = 63%). CONCLUSIONS: Administration of MRA may reduce mortality after acute MI. However, this is largely based on post-MI patients with heart failure. Further data are needed in MI patients without heart failure.

Heparin use for diagnostic cardiac catheterization with a radial artery approach: An international survey of practice patterns.

OBJECTIVES: We aimed to describe global practice patterns of unfractionated heparin (UFH) use for diagnostic transradial cardiac catheterization. BACKGROUND: The use of the radial artery approach for cardiac catheterization is increasing globally. Limited contemporary data exist to support the use or optimal dosing of UFH to prevent radial artery occlusion (RAO) and other thromboembolic complications. METHODS: We performed a web-based international survey of 450 interventional cardiologists from 34 countries. We collected information regarding the experience and use of UFH for diagnostic transradial cardiac catheterization. RESULTS: The survey was conducted between June and July 2016 and was completed by 227 (50.4%) interventional cardiologists. Overall, 83.3% performed >75% of their coronary angiograms via a radial approach, with the plurality (41.9%) having 10-20 years of clinical experience. Of all respondents, 7.5% did not use UFH for routine diagnostic transradial heart catheterization. Of the 92.5% who did use UFH, it was preferentially administered intra-arterially by 60% and intravenously by 40%. The majority (62.6%) of interventionalists used a fixed UFH dose with 5,000 IU being the most common dose (used in 48%). For those using a weight-based UFH (50 IU/kg) dosing regimen for diagnostic procedures (36.1%), the administered UFH dose ranged from 2,000 up to 10,000 IU. CONCLUSIONS: Despite the lack of firm evidence, the majority of interventional cardiologists who participated in the survey use UFH to prevent RAO for diagnostic transradial coronary angiography. However, there exist large practice disparities with regards to dose and route of administration. Given this knowledge gap, a dedicated randomized trial is warranted.

Left atrial anatomy, atrial fibrillation burden, and P-wave duration-relationships and predictors for single-procedure success after pulmonary vein isolation.

Aims: Atrial fibrillation (AF) is associated with changes in left atrial (LA) volume, but the relationship between LA size, AF burden, and electrical conduction behaviour is still uncertain. The aim of this study was to quantify the association and impact of these parameters on the single-procedure outcome after circumferential antral ablation for pulmonary vein isolation. Methods and results: Left atrial assessment was performed in 129 consecutive patients using pre-procedural imaging in three dimensions (sphericity, indexed volume), two dimensions (diameters), and from echocardiography in one dimension (long axis). Atrial fibrillation burden was classified based on the clinical assessment as paroxysmal and persistent and based on a validated scoring system including frequency, duration of AF episodes, and number of cardioversions into four grades (minimal, mild, moderate, and severe). P-wave duration and PR interval was measured on the 12-lead electrocardiogram at the end of the procedure. Atrial fibrillation burden score (AFB) was minimal (2%), mild (75%), moderate (9%), and severe (14%) and 65% had paroxysmal and 35% had persistent AF. The recurrence rate was significantly higher in patients with persistent AF, with higher AFB, with prolonged P-wave, and with an indexed LA volume > 55 mL/m2. In multivariable analysis, AFB (hazard ratio: 2.018(1.383-2.945), P > 0.001) and a prolonged P-wave (hazard ratio: 2.612(1.248-5.466), P = 0.011) were identified as significant predictors for AF recurrence. Conclusions: In our cohort of patients with symptomatic AF, the AFB and the P-wave duration but none of the anatomical parameter revealed to be independent predictors for AF/AT recurrence after circumferential antral pulmonary vein isolation.

Conventional versus 3-D Echocardiography to Predict Arrhythmia Recurrence After Atrial Fibrillation Ablation.

BACKGROUND: Arrhythmia recurrence after atrial fibrillation (AF) ablation remains high and requires repeat interventions in a substantial number of patients. We assessed the value of conventional and 3-D echocardiography to predict AF recurrence. METHODS AND RESULTS: Consecutive patients undergoing AF ablation by means of pulmonary vein isolation were included in a prospective registry. Echocardiograms were obtained prior to the ablation procedure, and analyzed offline in a standardized manner, including 3-D left atrial (LA) volumetry and determination of LA function and sphericity. The primary endpoint, AF recurrence (>30 seconds) between 3 to 12 months after AF ablation, was independently adjudicated. We included 276 patients (73% male, mean age 59.9 ± 9.9 years). Paroxysmal and persistent AF were present in 178 (64%) and 98 (36%) patients, respectively. Mean left ventricular ejection fraction and indexed LA volume in 3-D (LAVI) were 52 ± 12% and 42 ± 13 mL/m2 , respectively. AF recurrence was observed in 110 (40%) patients after a single procedure. Median (interquartile range) time to AF recurrence was 123 (92; 236) days. In multivariable Cox regression models, the only predictors for AF recurrence were the minimal, maximal, and indexed 3-D LA volumes, P = 0.024, P = 0.016, and P = 0.014, respectively. Quartile specific analysis of 3-D LAVI showed an HR of 1.885 (95%CI 1.066-3.334; P for trend = 0.015) for the highest compared to the lowest quartile. CONCLUSION: Our results show the important role of LA volume for the long-term freedom from arrhythmia after AF ablation. These data also highlight the potential of 3-D echocardiography in this context and may facilitate patient selection for AF ablation.

Plasma levels of endothelin-1 and renal function among young and healthy adults.

BACKGROUND: Endothelin-1 (ET-1), a vasoconstrictive and pro-inflammatory peptide, is associated with several cardiovascular risk factors and outcomes. We aimed to investigate the association of plasma ET-1 levels and renal function among young and healthy adults. METHODS: Individuals aged 25-41 years were enrolled in a population-based cohort study. Main exclusion criteria were established kidney disease, cardiovascular diseases, diabetes mellitus and a body mass index>35 kg/m2. Fasting venous plasma samples were used to measure creatinine, cystatin C and ET-1. The estimated glomerular filtration rate (eGFR) was calculated using the creatinine based chronic kidney disease epidemiology collaboration (CKD-EPI) formula. Multivariable regression models were constructed to assess interrelationships of plasma ET-1 with parameters of renal function. RESULTS: Median age of the 2139 participants was 37 years, 47% males. Median creatinine and eGFR were 67 µmol/L and 112 mL/min/1.73 m2, respectively. Using quartile one as the reference group, the ß-coefficients (95% confidence intervals [CIs]) for eGFR were 0.06 (- 1.22 to 1.35),-0.66 (- 1.95 to 0.62) and-1.70 (- 3.01 to-0.39) for quartiles 2-4 (p-for-trend=0.0056), respectively and ß-coefficients (95% CIs) for cystatin C were 0.002 (- 0.01 to 0.02), 0.02 (0.003-0.03) and 0.03 (0.01-0.04) for quartiles 2-4 (p-for-trend<0.0001), respectively. Using ET-1 as a continuous variable, the ß-coefficient (95% CI) for eGFR per 1-unit increase was-1.82 (- 3.19 to-0.44, p=0.0095) and 0.02 (0.01-0.04, p=0.0003) for cystatin C. Similar results were found between creatinine and ET-1 levels. CONCLUSIONS: ET-1 levels are strongly associated with parameters of renal function among young and healthy adults, suggesting an important role of ET-1 and endothelial function in the regulation of kidney function.

The interrelationships of birthweight, inflammation and body composition in healthy adults.

BACKGROUND: Lower birthweight is associated with an increased risk of cardiovascular diseases and diabetes. We hypothesized that inflammation and body fat may be potential mediators for these inverse relationships. MATERIALS AND METHODS: Healthy adults aged 25-41 years were enrolled in a prospective population-based cohort study in the Principality of Liechtenstein. Main exclusion criteria were diabetes, overt cardiovascular disease or a body mass index > 35 kg/m(2) . Birthweight was self-reported by the study participants. White blood cell (WBC) count and high-sensitivity C-reactive protein (hs-CRP) levels were assayed from fresh blood samples. Body composition was determined by bioelectrical impedance analysis. Multivariable linear regression models were constructed to assess the relationships between birthweight, inflammation and body composition. RESULTS: Our sample consisted of 1774 participants (53·4% females) with a median age of 37 years. Median birthweight was 3355 g. In multivariable models, we found an inverse relationship of birthweight with hs-CRP levels (ß -0·010 (95% CI -0·02; -0·002), P = 0·01) and WBC count (ß -0·002 (95% CI -0·004; -0·0002), P = 0·03). Additional adjustment for body fat mass attenuated these relationships (ß -0·008 (95% CI -0·02; 0·0003), P = 0·06 for hs-CRP levels and (ß -0·002 (95% CI -0·004; 0·0006), P = 0·16 for WBC count. Body fat mass itself was strongly associated with birthweight (ß -0·06 (95% CI -0·10; -0·03), P < 0·0001). CONCLUSION: Birthweight is inversely associated with inflammation in adulthood. This relationship may be mediated by an elevated body fat mass among individuals with lower birthweight.

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients With Chronic Inflammatory Disease.

BACKGROUND: Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis. METHODS AND RESULTS: From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P=0.002) and more often had pulmonary disorders (21% versus 13%, P=0.046) and atrial fibrillation (32% versus 20%, P=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID. CONCLUSIONS: This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

The impact of elevated C-reactive protein levels on long-term outcomes of patients undergoing transcatheter aortic valve replacement.

BACKGROUND: In patients undergoing transcatheter aortic valve replacement (TAVR), elevated pre-procedural C-reactive protein (CRP) levels are frequently observed. Its impact on long-term results of TAVR is unclear. The aim of the study was to investigate the long-term (up to six years) clinical outcomes of TAVR patients with normal compared to elevated CRP levels before TAVR. METHODS: Consecutive patients undergoing TAVR between August 2012 and January 2023 at a tertiary cardiology facility were included. Patients were divided into two cohorts based on the baseline CRP levels: normal CRP (≤ 5 mg/l) and elevated CRP (>5 mg/l). The cohorts were followed clinically for up to six years after TAVR. RESULTS: From a total of 1000 TAVR patients (mean age 81 ± 6 years), 268 patients (27 %) were found to have elevated baseline CRP (>5 mg/l). Such patients had significantly more co-morbidities (e.g. chronic obstructive pulmonary disease, atrial fibrillation, heart failure, concomitant valvopathies). They also developed periprocedural infections more frequently (3 % vs. 1 %, p = 0.007) and required more commonly repeat hospitalizations for infections during follow-up (HR 1.97, CI 1.47-2.64, p < 0.001). All-cause mortality and development of valve dysfunction did not significantly differ between patients with elevated and normal baseline CRP levels. CONCLUSION: Albeit long-term results of TAVR patients with elevated pre-procedural CRP levels seem favorable in terms of survival and development of valve dysfunction, they have an increased risk for periprocedural infections and re-admissions due to infections of any type during the follow-up period.