bluuebunny/crossref_metadata_2025 huggingface dataset:
The impact of underlying plaque characteristics following the novel resorbable magnesium scaffold implantation: an intravascular OCT assessment up to 12-months
Authors: Aytekin A , Seguchi M , Xhepa E , Haude M , Wlodarczak A , Van Der Schaaf R J , Torzewski J , Ferdinande B , Escaned J , Iglesias J F , Bennett J , Toth G , Toelg R , Garcia-Garcia H M , Joner M
Published: November 2023

Background

Second-generation resorbable magnesium scaffold (RMS) Magmaris showed favorable outcomes in clinical trials, especially regarding the incidence of scaffold thrombosis. The earlier studies reported a higher occurrence of scaffold recoil with this RMS owing to vessel constriction. This finding was shown to be more prominent in presence of underlying fibrous plaques rather than calcific and/or lipidic lesions. This suggest that sufficient radial force along with longer scaffolding time may improve the device performance. Against this background, DREAMS 3G was developed with stronger mechanical properties despite thinner struts by modifying the magnesium alloy of its predecessor. The first-in-man trial BIOMAG-I demonstrated promising results for the novel RMS with respect to clinical and angiographic outcomes at 6 months follow-up. Still, the data concerning the performance of DREAMS 3G scaffold up to 12-months are lacking.

Purpose

This study aims to assess the influence of the intravascular optical coherence tomography (OCT) -derived underlying plaque characteristics on mean lumen area (mm 2) in patients treated with DREAMS 3G at 6- and 12-months.

Methods

Patients enrolled in the BIOMAG-I trial and who underwent OCT imaging (i) at index-procedure, (ii) at 6-months and (iii) at 12-months follow-up were included in the current analysis. The acquired intravascular imaging data were evaluated every 1 mm on a quadrant basis to assess the presence of fibrous, calcific, or lipidic lesions. We calculated the proportions of each plaque feature per pullback, then assessed their correlation with the mean lumen area obtained at 6- and 12-months follow-up. In addition, we investigated the potential impact of scaffold edge dissection on the mean lumen area.

Results

Fifty-one patients and 52 lesions were evaluated in the current analysis. There was no significant correlation between the underlying plaque characteristic and mean lumen area at 6-months (p=0.767 for fibrous, p=0.761 for calcific, p=0.767 for lipid lesions). This trend was similar at 12 months follow-up (p=0.499 for fibrous, p=0.714 for calcific, p=0.569 for lipid lesions). Finally, the presence of edge dissection did not correlate with mean lumen area (p=0.559 and p=0.670 at 6- and 12-months follow-up, respectively).

Conclusion

The underlying plaque characteristics and the presence of edge dissection had no significant impact on the mean lumen area following DREAMS 3G implantation up to 12 months. These results suggest better device performance with the novel RMS irrespective of the underlying plaque characteristics.
Appropriate ischemic criteria for type 4a myocardial infarction: insights from the ALPHEUS trial
Authors: Roule V , Zeitouni M , Guedeney P , Beygui F , El Kasty M , Braik N , Bertin B , Brugier D , Range G , Motovska Z , Cayla G , Vicaut E , Montalescot G , Silvain J
Published: November 2023

Background

Different troponin thresholds have been proposed to define periprocedural myocardial injury based on post percutaneous coronary intervention (PCI) troponin increase only, whereas the definition of type 4a myocardial infarction (MI) needs the association of post procedural troponin and one ischemic criterion. These criteria which evolved from the 3rd to the 4th Universal Definition of Myocardial Infarction (UDMI) are frequently under-reported in studies on periprocedural MI.

Purpose

We aimed to describe rates of type 4a MI additional diagnostic criteria among the ranges of post PCI troponin elevation in the randomized ALPHEUS trial which compared ticagrelor to clopidogrel in high-risk elective PCI patients.

Methods

1698 patients with normal pre-PCI troponin values and centralized core laboratory angiogram analyzes were divided into 4 groups according to maximal post PCI troponin elevations (≤ 1x upper reference limit (URL) for group 1; > 1xURL and ≤ 5xURL for group 2; > 5xURL and < 35xURL for group 3 and ≥ 35xURL for group 4). The type 4a MI additional criteria (ischaemic imaging changes, ischaemic ECG changes, chest pain and angiographic complications) as defined by the 3rd and 4th UDMI were reported and the different angiographic complications were detailed for each group.

Results

The most prevalent additional ischemic criterion was the presence of angiographic complications detected by the core laboratory. The rate of angiographic complications increased in a stepwise manner with higher post PCI troponin elevation (Figure). Interestingly, we found a similar rate of angiographic complications in patients without any increase in post PCI troponin and troponin elevations below the 5xURL threshold (8.4% and 9.9% respectively). Most angiographic complications were related to transient main branch dissection and/or thrombosis, and transient or permanent side branch occlusions (Table). ECG changes and chest pain ischemic criteria also increased in a stepwise manner and were rarely found below the 5-fold threshold increase, although they might be underreported.

Conclusion

When using a core laboratory, angiographic complications are found even in patients with no or minor troponin elevation. Above the 5 xURL threshold the rates of angiographic complications are 2 to 3-fold more frequent, and ECG changes and chest pain ischaemic criteria are likely to be present. Our findings support the use of angiographic core laboratory in clinical trial using periprocedural MI as an endpoint; similarly, chest pain -which disappeared from the 4th UDMI- should be reconsidered as a diagnostic ischemic criterion.
Cerebral embolic protection devices during transcatheter aortic valve implantation: a meta-analysis of randomised controlled trials
Authors: Reddy R K , Ahmad Y , Arnold A D , Howard J P
Published: November 2023

Background

Stroke is a feared complication of transcatheter aortic valve implantation (TAVI), which may be mitigated by embolic protection devices (EPDs).

Purpose

We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) to test the effect of EPDs in TAVI.

Methods

All RCTs comparing EPDs with control during TAVI were systematically identified. Pre-specified primary endpoints were all stroke, disabling stroke, non-disabling stroke and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. This study was prospectively registered.

Results

Eight trials randomising 4043 patients were included. There was no significant difference between EPDs and control for all stroke [RR 0.88, 95%CI 0.65–1.18, p=0.386, I2=0%], disabling stroke [RR 0.59, 95%CI 0.31–1.14, p=0.117, I2=0%], non-disabling stroke [RR 0.99, 95%CI 0.71–1.40, p=0.967, I2=0%] or all-cause mortality [RR 0.88, 95%CI 0.44–1.78, p=0.727, I2=0%]. There were no differences in safety endpoints of bleeding, vascular complications, or acute kidney injury. EPDs resulted in reduced cerebral lesion volume [SMD -0.55, 95%CI -0.91– -0.18, p=0.003, I2=63.6%], but no difference in number of patients with new lesions. The Sentinel EPD significantly reduced risk of disabling stroke [RR 0.42, 95%CI 0.20–0.88, p=0.022, I2=0%] but did not impact all stroke, non-disabling stroke or all-cause mortality.

Conclusion

The totality of randomised data for EPDs during TAVI demonstrated no safety concerns or significant differences in clinical endpoints, although total cerebral lesion volume was reduced. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.Effects of cerebral embolic protectionEffects of the Sentinel device
Mid-term outcomes in aortic stenosis patients treated with contemporary balloon expandable and self-expanding valves; does valve size have an impact on outcome?
Authors: Kalogeras K , Jabbour R , Pracon R , Kabir T , Shannon J , Duncan A , Oikonomou E , Katsianos E , Patel N , Cadiz S , Siasos G , Vavouranakis M , Davies S , Dalby M , Panoulas V
Published: November 2023

Background

No data currently exists comparing the performance of the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. In addition, no direct head to head comparisons of the aforementioned devices have been performed in patients with small annuli with the exception of small registries.

Purpose

Aim of the study was the head-to-head comparison of these transcatheter heart valves (THV) with emphasis on patients with small aortic annulus.

Methods

In this retrospective registry, peri-procedural outcomes and mid-term all-cause mortality were analyzed.

Results

1673 patients (917 SE vs. 756 BE) were followed-up for a median of 15 months. Baseline demographics were similar apart from worse left ventricle systolic function amongst SE patients and more extensive coronary artery disease amongst BE patients. 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at one (92.6 vs. 90.6%) and three-years (80.3% vs. 85.2%), plog-rank=0.136.

Compared to the BE group, patients treated with SE device had lower peak (16.3±8mmHg SE vs. 21.9±8mmHg BE, p=0.001) and mean (8.8±5mmHg SE vs. 11.5±5mmHg BE, p=0.001) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation (PVR) post-operatively (5.6% vs. 0.7% for SE and BE valves respectively, p<0.001).

In patients treated with small THV (≤26 for SE and ≤23mm for BE; N=284 for SE and N=260 for BE) survival was higher amongst patients treated with SE valves at both 1 (96.7% SE vs. 92.1% BE) and 3-years (91.8% SE vs. 82.2% BE), plog-rank=0.042.

Conclusions

Real-world comparison of the latest generation SE and BE devices demonstrated similar survival up to 3 years follow-up. Among patients with small aortic annulus, those treated with SE valves seem to demonstrate improved survival rates.36months survival rates
Acute ischemic stroke complicating tavi. predictors, outcomes, and treatment associated outcomes
Authors: Kheifets M , Kruchin B , Aviram I , Vaknin-Assa H , Barnea R , Findler M , Perl L , Witberg G , Codner P , Talmor-Barkan Y , Rephaeli G , Uriel E , Kornowski R , Levi A
Published: November 2023

Introduction

Despite the great strides made since the emergence of TAVI two decades ago, periprocedural ischemic stroke remains a major concern. The aims of this study were to describe the incidence, characteristic and outcomes of patients presenting with acute ischemic stroke complicating TAVI (AISCT), and to compare conservative therapy vs. neurointervention, in eligible patients.

Material and method

We analyzed consecutive TAVI procedures performed in our medical center between 2008 and 2021. Patients with and without AISCT were compared. Outcomes of neurointervention to treat AISCT were compared to conservative therapy. Primary outcomes were mortality at 1 and 3 year and neurologic disability status at 3 months.

Results and discussion

Of 1145 eligible patients who underwent TAVI between 2008-2019, 29 (2.5%) had AISCT within 30 days. All-cause mortality was significantly higher in the AISCT group in 30-days (13.8% vs. 2.9%, p<0.01), 1-year (27.9% vs. 8.1%, p<0.01), and 3-years (50.1% vs. 25.1%, p<0.01), as compared to the AISCT negative group. Lower body mass index (OR- 1.11, 95%CI 1.01-1.21, p=0.03) prior ischemic stroke (OR- 2.80, 95%CI 1.23-6.01, p<0.01) and frailty (OR- 2.98, 95%CI 1.27-6.49, p<0.01) emerged as independent risk factors for stroke. Out of the 38 patients who suffered AISCT between 2008-2021, 7 underwent neurointervention. The majority of AISCT were observed within the first 24-hours following TAVI (p<0.01). All-cause mortality following severe stroke was significantly higher (p<0.01) compare to mild or moderate stroke. There were no significant differences in mortality between the two groups, however, patients with moderate severity stroke (NIHSS score 6-14) undergoing neurointervention enjoyed a higher rate of disability free survival at 3-months compared to patients treated conservatively. (100% compared to 50% respectively, p=NS).

Conclusion

AISCT was associated with increased morbidity and mortality. Neurointervention, as compared to conservative therapy, may improve disability status in patients with moderate or severe stroke.
Redo transcatheter edge-to-edge mitral valve repair: a single centre experience
Authors: Makmal N , Butnaru A , Silbermintz N , Faierstein K , Raphael R , Moeller C , Canetti M , Maor E , Kuperstein R , Hai I , Oren D , Guetta V , Fefer P
Published: November 2023

Introduction: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a therapy for patients with severe symptomatic mitral regurgitation (MR) who are at high surgical risk. Failure to implant a TEER device and the occurrence of residual or recurrent MR ≥3+ are well documented but data regarding outcomes of redo-TEER following initial failure are sparse.

Purpose

To evaluate the safety and efficacy of redo-TEER following initial failed intervention.

Methods

We included 16 patients who underwent redo-TEER for symptomatic MR ≥3+ from July 2016 to December 2022. Acute results were assessed by echocardiography prior to discharge and safety was evaluated clinically, according to the occurrence of procedure-related adverse events. Mid- and long-term outcomes were evaluated at three months and one year respectively. Data were obtained retrospectively by chart review. Mortality data were drawn from the national death registry.

Results

Reasons for redo-TEER include device failure without detachment in nine (56%) patients, device failure due to single leaflet detachment in four (25%) patients and initial implantation failure in three (19%) patients. Median time from index procedure was 167 days (range: 19 – 1457 days). Technical (implantation of a TEER device) and procedural (MR ≤2+ at discharged) success were achieved in 94% and 87.5% of patients undergoing repeat intervention respectively. MR grade was reduced to 1+ in 71% of patients who had successful TEER. No intra-procedural mortality or life-threatening complications were noted. Mean post-TEER hospitalization length was 1.8 ± 1.3 days. No deaths were noted during the first year following redo-TEER. Echocardiography at three months and one year demonstrated MR ≤2+ for all patients in whom TEER was successful. At three months and one-year follow-up, respectively 67% and 50% of patients who underwent successful intervention were in New York Heart Association (NYHA) class I or II and only one had been hospitalized for heart failure.

Conclusion

Repeat mitral TEER following initial procedural failure is safe and has high acute and mid-term success rates. More research is needed to better characterise patients likely to benefit from repeated intervention.
Transcatheter-edge-to-edge-repair of functional mitral regurgitation in advanced HFrEF: the impact of intrinsic left ventricular performance on the degree of MR reduction and clinical outcome
Authors: Schmeisser A , Rauwolf T , Groscheck T , Tiedge M , Tanev I , Meissler S , Hansen M , Luani B , Bekfani T , Steendijk P , Braun-Dullaeus R U E D I G
Published: November 2023

Background

Transcatheter-edge-to-edge-repair (TEER) of functional mitral regurgitation (FMR) reduces rehospitalisation and all-cause mortality in patients with HFrEF/HFmrEF. Not conclusively clarified is the interaction of pre-interventional intrinsic left ventricular (LV) function with TEER success and clinical outcome.

By using the gold standard of LV contractility analysis, the invasive pressure-volume loop technique, we examined the interaction of pre-and post-interventional intrinsic LV performance with the degree of MR reduction and all-cause mortality after TEER in patients with advanced HFrEF.

Methods

In a prospective study of 71 patients with advanced HFrEF (median EF 26%, 22-31%) and severe FMR, we quantified different intrinsic parameters of LV performance by PV-loop analysis (single beat analysis) pre-and post-interventionally.

Results

In 83% of the patients a MR reduction to grad < 2 could be achieved (hospital discharge). In the ROC analysis, the best cut-off to separate medium-term survival from all-cause mortality (median FU 2.9 years) was a post-interventional regurgitation fraction (RF) < 20% (AUC 0.72, p<0.001, sensitivity 83%, specificity 60%) and a R-volume (RV) < 18ml (AUC 0,7, p=0.002, sensitivity 67%, specificity 72%). The PV-loop-derived intrinsic LV contractility (LV-endsystolic elastance, Ees), LV afterload (arterial elastance, Ea), LV-Ao-coupling (Ees/Ea), LV-mechanical efficacy (ME), PV-loop area (PVA), stroke work, Tau; end-diastolic elastance (Eed), LVEF, LVEDV, and LVESV, pre- and post-TEER, were not predictive for the extent of MR reduction acutely, after 6 months FU, and for all-cause mortality. In multivariate cox-regression analysis, only a post-interventional RF<20% (HR 0.36, p=0.017) or RV<18ml (HR 0.32, p=0.005) and the pre-interventional LV-contractile reserve (LV-CR: post-extra-systolic augmentation of LV-Ees) remained independent predictors of all-cause mortality. In a second model, we included the degree of LV-remodeling (LV-R: LVESV reduction from hospital discharge to 6 months) in the model. In addition to pre-interventional LV-CR, and RF<20%, the LV-R remains independent predictive for all-cause mortality.

Conclusion

In our peri-mitral-TEER LV-PV-loop study, only the extent of MR reduction and the pre-interventional LV-CR, but not the intrinsic LV performance at rest, determine the medium-term survival of patients with advanced HFrEF and FMR. TEER-mediated MR reduction itself seems not be determined by the LV performance.
Impact of transcatheter edge-to-edge repair (TEER) of mitral valve on the clinical outcomes in the management of atrial functional mitral regurgitation
Authors: Moras E , Gandhi K , Narasimhan B , Correa A , Mahmood K , Argulian E , Dominguez A
Published: November 2023

Background

Atrial functional mitral regurgitation (aFMR) has become a novel topic of interest. Data on the safety and efficacy of transcatheter edge-to-edge repair (TEER) of mitral valve among patients with aFMR and ventricular functional mitral regurgitation (vFMR) is scarce and limited to single center studies.

Purpose

We conducted a systematic review and meta-analysis to assess the safety and efficacy of TEER in the management of aFMR vs vFMR and its impact on clinical outcomes.

Methods

PubMed/MEDLINE, Cochrane Library and EMBASE databases were queried to identify studies comparing the efficacy of TEER between aFMR and vFMR. The primary outcome of interest was mortality at 1 year and composite of all-cause mortality and heart failure (HF) hospitalizations. Secondary outcomes included mitral regurgitation (MR) reduction, presence of residual MR, improvement in NYHA functional class, postoperatively and at 1-year. Risk ratios (RR’s) and their corresponding 95% confidence intervals (CIs) were calculated using random-effects model.

Results

We included a total of 3,314 patients from 6 observational studies which met the inclusion criteria (mean age 63.8 ± 3.8 years, 43% male). There were 443 aFMR patients and 2871 vFMR patients with an average follow-up of 12 months. Mortality at 1-year and the composite outcome of all-cause mortality and heart failure hospitalizations were comparable between aFMR and vFMR groups (RR 1.06; 95% CI 0.64 - 1.75; p = 0.81 and RR 0.92; 95% CI 0.75 - 1.14; p = 0.47, respectively). There were no significant differences between aFMR and vFMR groups in terms of MR reduction postoperatively (RR 0.99; 95% CI 0.96 - 1.02; p = 0.53) or at 1-year (RR 1.15; 95% CI 0.96 - 1.38; p = 0.14). Moreover, the presence of residual MR grade ≥ 3+ postoperatively (RR 1.31; 95% CI 0.83 - 2.08; p = 0.25) and at 1-year (RR 0.96; 95% CI 0.44 - 2.11; p = 0.92) was similar between aFMR and vFMR cohorts. Overall, although there was a clinical improvement in symptoms in terms of NYHA functional class at 1 year (grade ≤ 2), there was no statistical significance between the two groups (RR 1.02; 95% CI 0.93 - 1.11; p = 0.74).

Conclusion

This meta-analysis suggests that transcatheter edge-to-edge repair is likely to be an efficacious and safe option in patients with aFMR and vFMR. Future randomized control trials are needed to fully assess the clinical impact of this procedure in the two MR etiologies.Figure 1Figure 2
Urgent Transcatheter Edge-to-Edge Repair (TEER) of severe mitral regurgitation in patients with cardiogenic shock: A systematic review and meta-analysis of 5,428 patients
Authors: Soulaidopoulos S , Dimitriadis K , Sagris M , Beneki E , Tsiachris D , Pananikolaou A , Tsioufis P , Aznaouridis K , Tousoulis D , Aggeli K , Tsiamis E , Tsioufis K
Published: November 2023

Background

Patients presenting with severe mitral valve regurgitation (MR) and cardiogenic shock (CS) demonstrate a poor prognosis and high mortality rate. Transcatheter edge-to-edge repair (TEER) of the mitral valve regurgitation with MitraClip may alter patient management while alleviating hemodynamic instability.

Aim

To perform a systematic review of the published literature and meta-analysis on the use of MitraClip in patients with severe MR and CS.

Methods

We performed a systematic review and meta-analysis according to the PRISMA guidelines. We systematically explored published literature in MEDLINE (Pubmed) before January 8, 2023, for studies assessing urgent TEER with MitraClip in patients presenting with severe MR and CS. CS was defined as 1) CS according to ICD-10; 2) inotrope use; or 3) mechanical circulatory support before TEER. The primary outcome was device success and all-cause mortality rates while the secondary outcome was the incidence of myocardial infarction (MI), stroke, and hospitalization for heart failure (HF), during in-hospital/30-days and long-term periods. We calculated I² to test heterogeneity. We used random-effects modeling for the meta-analyses to assess the primary and secondary outcomes.

Results

In total 25 studies, including 5,428 patients met the predefined eligibility criteria and were included in this meta-analysis. During the in-hospital/30-day period, device success was achieved in 86% (95% CI: 80%-91%, I2 =49%) with MR ≤2+ to be described in 87% (95% CI: 79%-93%, I2 =75.8%) of the cases, while the overall all-cause mortality was 14% (95% CI: 10%-19%, I2 =84%). The incidence of MI and stroke hovered at 4% (95% CI: 1%-13%, I2 =92%) and 2% (95% CI: 1%-2%, I2 =0%), respectively. During a mean follow-up of 10.6 ± 6.4 months, the all-cause mortality was increased to 31% (95% CI: 24%-39%, I2 =92%), while hospitalization for HF is needed in 18% (95% CI: 9%-29%, I2 =80%) of the patients. In the subgroup analysis of patients in CS due to acute MI who underwent urgent TEER, 11 studies and 352 patients were included. Device success was achieved in 92% (95% CI: 75%-100%, I2 =77.8%) and the in-hospital/30-day mortality was 13% (95% CI: 5%-21%, I2 =60%). In a mean follow-up of 10.2 ± 8.3 months, long-term all-cause mortality fluctuated at the same rate of around 11% (95% CI: 2%-23%, I2 =70%).

Conclusion

The use of MitraClip in patients with MR and concurrent CS is associated with improved in-hospital/30-day and long-term survival. Our findings indicate that using MitraClip in the acute phase is a safe approach that can significantly reduce all-cause mortality, MI, stroke, and re-hospitalization for HF in this patient population.
Perioperative aspirin and coronary artery bypass graft surgery: a meta-analysis of randomised controlled trials
Authors: Zaka A , Gupta A , Lombardo A , Kovoor J , Bacchi S , Smith J , Bennetts J , Maddern G
Published: November 2023

Background

Although consensus guidelines demonstrate clear benefit for the continuation of aspirin in patients awaiting coronary artery bypass grafting (CABG) following an acute coronary syndrome where risk of re-infarction outweighs bleeding risk, the evidence remains unclear in the case of elective CABG. We performed the largest to date systematic review and meta-analysis to compare outcomes between CABG patients who stopped and continued aspirin perioperatively.

Methods

A thorough search of PubMed, MEDLINE and CENTRAL databases was conducted to 25th July 2022 for randomized control trials that evaluated patients undergoing CABG. Summary odds ratios were calculated using a random effects model for dichotomous and continuous variables. Subgroup and sensitivity analyses were conducted in order to explore sources of heterogeneity.

Results

16 eligible studies were included with a total of 6188 patients who underwent CABG. Patients who continued Aspirin perioperatively demonstrated an increased risk of all cause mortality [OR 1.37 (0.81-2.33)] and reduced risk of perioperative myocardial infarction [OR 0.81 (0.55-1.18)], however neither were statistically significant. No significant difference was observed between low-dose and higher doses of Aspirin. There was minimal heterogeneity amongst included studies (i2 = 0%, p=0.97 and i2=33%, p=0.13 respectively). Continuing aspirin produced a modest increase in postoperative blood loss [mean difference 66.12mL (-1.45-133.69)], as was a dose greater than 100mg [216.87(-152.99-586.72), p=0.60], however this was not statistically significant.

Conclusion

Continuing Aspirin before CABG is not associated with a significantly increased risk of all-cause mortality, of perioperative myocardial infarction, and of postoperative bleeding. Future trials with more robust methodology should be aimed at further evaluating this patient cohort to guide perioperative Aspirin use.
Sleep apnoea is associated with long-term cardiovascular outcomes in patients undergoing coronary artery bypass grafting
Authors: Teo Y , Teo Y N , Yong C L , Chan J , Tan W W , Lee C H , Koo C Y
Published: November 2023

Background

Sleep apnoea is highly prevalent in patients undergoing coronary artery bypass grafting (CABG), and is associated with poorer peri-operative outcomes. However, whether sleep apnoea is associated with long-term cardiovascular outcomes remain unknown.

Purpose

We aimed to examine the relationship between sleep apnoea and long-term major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing non-urgent CABG. MACCE was a composite endpoint that comprised cardiovascular mortality, non-fatal myocardial infarction, no-fatal stroke, and unplanned revascularisation.

Methods

This was a prospective cohort study with five years follow-up. Between 2013 and 2018, a total of 1007 patients referred to a tertiary cardiac centre for non-emergent CABG were recruited. All the participants underwent an overnight sleep study using an FDA-approved portable diagnostic device. Sleep apnoea was diagnosed when the apnoea-hypopnoea index was ≥15 events per hour. The clinical team involved in patient care was independent of the research project and blinded to the sleep study results.

Results

The sleep apnoea (n=513 patients, 50.9%) and non-sleep apnoea groups did not differ in terms of surgical complexity, based on the number of bypass grafts and the estimated blood loss. Fourteen patients died, including nine in the sleep apnoea and five in the non-sleep apnoea group. At an average follow-up of 4.8 years, the overall cohort had 221 patients (21.8%) experienced the four-component MACCE. This included 59 cardiovascular deaths (5.9%), 85 non-fatal myocardial infarctions (8.4%) , 90 non-fatal strokes (8.9%), and 71 unplanned revascularizations (7.1%). Compared with the non-sleep apnoea group, the sleep apnoea group experienced a higher crude incidence of MACCE (estimated 5-year incidence, 24.6% vs 17.2%, p=0.011). For the individual components, the incidence of cardiovascular death (6.6% vs 4.1%, p=0.071), non-fatal myocardial infarction (9.2% vs 7.7%, p=0.02), and non-fatal stroke (9.6% vs 8.3%, p=0.41) was higher in the sleep apnoea than the non-sleep apnoea group. The incidence of unplanned revascularizations was similar between the two groups (7.0% vs 7.1%, p=0.96). The Kaplan-Meier survival curve is shown in Figure 1. In the Cox regression analysis, sleep apnoea was associated with a higher incidence of MACCE (unadjusted Hazard Ratio [HR]=1.41, 95% Confidence Interval [CI]: 1.08 - 1.85, p=0.011). After adjustment for the effects of age, gender, body mass index, left ventricular ejection fraction, diabetes mellitus, hypertension, chronic kidney disease, and excessive daytime sleepiness, sleep apnoea was independently associated with MACCE (adjusted HR: 1.32; 95% CI: 1.01-1.73; p=0.041).

Conclusion

To the best of our knowledge, this is the first report showing that in patients undergoing an non-urgent CABG, sleep apnoea was independently associated with a 30% higher risk of MACCE over a long-term follow-up period.
Incidence and risk factors for permanent pacemaker implantation in patients undergoing tricuspid valve surgery
Authors: Kassab J , Harb S C , Desai M Y , Chedid El Helou M , El Dahdah J , Nakhla S , Elgharably H , Kapadia S R , Cremer P C , Mentias A
Published: November 2023

Background

Bradyarrhythmias requiring permanent pacemaker (PPM) implantation are commonly described after cardiac surgeries. Numerous studies evaluated the demographic and clinical risk factors for PPM placement following aortic and mitral valve surgeries. However, a paucity of data exists when it comes to tricuspid valve surgery (TVS).

Purpose

Our study aimed to evaluate the incidence of PPM placement after TVS and investigate the demographic, clinical, and procedural risk factors associated with the need for a PPM.

Methods

We included 13 294 patients from the Medicare database who underwent isolated TV repair (N=1319 (10%)), isolated TV replacement (N=2123 (16%)), or concomitant TV repair or replacement with different combinations of surgical aortic valve replacement (SAVR), mitral valve repair or replacement (MVR), and coronary artery bypass graft (CABG). Patients who underwent TV surgery for endocarditis were excluded. The primary exposure of interest for the study was new pacemaker placement after TV surgery and before discharge, or within 30 days from discharge date. Each patient from the pacemaker group was matched to up to 3 controls from the no pacemaker group.

Results

Among the included patients, 2518 (18.9%) required a PPM placement after TVS. In the logistic regression including patients’ variables, subjects who needed PPM implantation were more likely to be women (64.4% vs. 57.6%, P<0.001) and had a higher prevalence of prior sternotomy (P=0.01), chronic kidney disease (P=0.03), heart failure (P=0.04) and tumor (P=0.02). Patients who underwent isolated TV replacement and TV replacement with concomitant surgeries had a significantly higher risk of PPM implantation when compared to isolated TV repair and TV repair with concomitant surgeries (P<0.0001) (Table).

Conclusion

Post-procedural PPM implantation is a very frequent complication of TVS, especially in TV replacement with or without concomitant left-sided heart surgeries. Numerous demographic and clinical factors are associated with an increased risk of PPM placement. Adequate risk stratification and counseling of patients before surgery decision is essential.Demographic & Surgical Risk Factors
Sex specific associations between serum uric acid levels and risk of hypertension for different reference values of high blood pressure
Authors: Salim A , Kawasoe S , Kubozono T , Ojima S , Kawabata T , Ikeda Y , Miyahara H , Tokushige K , Ohishi M
Published: November 2023

Background

Uric acid (UA) has been linked to the development of hypertension. However the sex specific associations between UA levels and different diagnostic blood pressure (BP) references is unknown.

Purpose

We aimed to ascertain the association between serum UA quartiles, hyperuricemia, and 5-year hypertension incidence and weather lower BP diagnostic references may alter these associations in men and women without cardiometabolic diseases.

Methods

This 5-year study used the check-up data from a hospital. We excluded participants with hypertension (defined as BP ≥140/90 mmHg in cohort 1 and BP ≥130/80 mmHg in cohort 2), diabetes, dyslipidemia, obesity, estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m², metabolic syndrome, history of gout, and UA lowering medication. We categorized UA into quartiles as follows: men: 1st quartile UA≤4.8 mg/dL, 2nd quartile 4.9-5.6 mg/dL, 3rd quartile 5.7-6.4 mg/dL, and 4th quartile UA≥6.5 mg/dL; women: 1st quartile UA≤3.4 mg/dL, 2nd quartile 3.5-4.0 mg/dL, 3rd quartile 4.1-4.7 mg/dL, and 4th quartile UA≥4.8 mg/dL. Hyperuricemia was defined as UA>7 mg/dL in men and UA>6 mg/dL in women. To analyze the effects of UA on development of hypertension, we adjusted for age, body mass index, systolic BP, diastolic BP, tobacco smoking, alcohol consumption, exercise habit, serum triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting plasma glucose, and eGFR by sex in both cohorts. The outcome was 5-year hypertension incidence defined as BP ≥140/90 mmHg in cohort 1 and BP ≥130/80 mmHg in cohort 2.

Results

In total, 21,514 participants (age, 52.9±10.9 years; men, 39.8%), were enrolled in cohort 1, and 15,316 participants (age, 51.3±10.9 years; men, 36.5%), in cohort 2. The incidence of hypertension in cohort 1 and cohort 2 over a 5-year period was 16.3% and 29.7% in men and 10.9% and 21.4% in women, respectively. Using multivariable logistic regression, we found that when comparing the fourth to first UA quartile, there was an increased risk of hypertension in men in cohort 1, OR 1.36 (95% CI, 1.13-1.63, P<0.01) and cohort 2, OR 1.31 (95% CI, 1.09-1.57, P<0.01) but not in women, cohort 1, OR 1.14 (95% CI, 0.95-1.36, P=0.16) and cohort 2, OR 1.14 (95% CI, 0.98-1.34, P=0.10) respectively. In contrast, for hyperuricemia, we observed increased hypertension risk only in men in cohort 1, OR 1.23 (95% CI, 1.07-1.42, P=0.02) and women were associated with increased risk of hypertension in cohort 2, OR 1.57 (95% CI, 1.14-2.16, P<0.01) but not in men OR 1.15 (95% CI 0.95-1.40, P=0.15).

Conclusion

Uric acid effect on development of hypertension is affected by sex and incidence differs with the BP reference used. We emphasize on early UA screening to enhance hypertension prevention among cardiometabolic free population.Hypertension 5-Year Incidence Proportion
Association of cumulative systolic blood pressure load and stroke in patients without diabetes
Authors: Zhao Y , Zhang Y I , Li M O R A N
Published: November 2023

Objectives

The purpose of this study was to assess the association between cumulative systolic blood pressure (SBP) load and risk of stroke in patients without previous stroke and diabetes.

Methods

The present study was a post hoc analysis of patients enrolled in the SPRINT study. Cumulative SBP load was defined as the area under curve for SBP values >120 or 130 or 140mmHg respectively (named SBP load120, SBP load130 and SBP load 140 respectively) divided by the area under curve for all measured SBP values over a 48-month exposure period. Hazard ratios for the association between cumulative SBP load with stroke were estimated using Cox models.

Results

Only SBP load130, but not mean SBP, SBP standard deviation (SBP SD), time at therapeutic range (TTR); had a well-correlation with the incidence of stroke according to the restricted cubic spline curve (RCS). Grouping participants with tertiles of cumulative SBP load130 distinguished the incidence of stroke by K-M curve. Different Cox models indicated SBP load130 was an independent risk factor for stroke. For the prediction of stroke, only cumulative SBP load130，but not SBP load120 and SBP load140, outperformed mean SBP, TTR, SBP SD in terms of C-statistics and net reclassification indexes.

Conclusions

Cumulative SBP load may provide better prediction of stroke compared with traditional BP measures among patients without previous stroke and diabetes. 130mmHg could be the best cutoff value for predicting incidence of stroke by SBP load.abstract figure
A medical impact of war: the hypertension crises dynamic in an adjacent population
Authors: Tase A , Stefan C , Stanciulescu L , Calina F C , Tantu M
Published: November 2023

Background

The current military conflagration in Ukraine impacted also boundaring countries by fear military conflict extension in the region, often augmented by mass-media, as well as by real horror stories told by refugees.

Goal. The aim of our research was evolutive assessment of the hypertension (HTN) crises in our emergency units during last twenty months.

Method

In this observational study, we analysed 45.293 patient (pts) files during five distinct intervals: 24.06.2021-23.10.2021, as four months of peace (P), 24.10.2021-23.02.2022, as four months of pre-war army manœvres (PW), 24.02.2022-23.06.2022, as the first four months of war – Russian invasion (RI), 24.06.2022-23.10.2022, as next four months of war – Ukrainean counteroffensive (UC), and 24.10.2022 – 23.02.2023, as other four months of war – Russian destructive attacks (RD), statistically matched 1:1:1:1:1. The acquisition of arterial pressure values was performed by professional digital tensiometers.

Results

From a quite steady number of 150 +/- 14 pts daily, the distribution of HTN pts was: 29,17 (P); 38,21 (PW); 67,49 (RI); 43,58 (UC); 56,14 (RD). Concerning the HTN crises, the data are as follows: 12,43 (P); 14,97 (PW); 27,65 (RI); 16,28 (UC); 24,93 (RD). Demographically, the male predominance oscillated as follows: 68,32% (P); 65,89% (PW); 59,58% (RI); 62,37% (UC); 56,94% (RD). The medium age for HTN crises pts balanced as follows: 65,32 yrs (P); 64,97 yrs (PW); 62,18 yrs (RI); 63,74 yrs (UC); 62,85 (RD).

Conclusion

According to our outcomes, the stress and high anxiety caused by fear of war in the neighbourhood significantly influenced the incidence of HTN crises along the five abovementioned periods. The most dramatic data were registered during RI period. Taking into consideration that this war is irrepeatable, this research is unique.
Intensive blood pressure lowering in older people with hypertension: a systematic review and meta-analysis
Authors: Ahmad F , Nguyen T
Published: November 2023

Background

Hypertension is a prevalent chronic disease associated with increased risk of ischaemic heart disease, stroke, and heart failure, especially in older people. Recommendations on blood pressure target in older patients are not consistent among guidelines. While most guidelines suggested the target of systolic blood pressure (SBP) <140 mmHg or a more relaxing target of 150 mmHg in older people, several guidelines suggested a more intensive target of <130 mmHg or <120 mmHg.

Purpose

The objective of this study is to evaluate the benefits and adverse side effects of intensive blood pressure targets, defined as SBP <130mmHg, compared to standard blood pressure targets, defined as SBP <140mmHg, in older people with hypertension.

Methods

We performed a systematic review and meta-analysis of randomised controlled trials comparing intensive blood pressure targets (SBP <130mmHg) with standard blood pressure targets in older people (aged≥60 years). Pooled odds ratios (ORs) and 95% Confidence Intervals (95%CI) were estimated using a random-effects model. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. The study outcomes include all-cause mortality, cardiovascular mortality, major adverse cardiac events (MACE), acute coronary syndrome, stroke, heart failure, and adverse side effects including hypotension, syncope, falls and acute kidney injury.

Results

A total of 485 articles were identified, of these, 4 studies were included in this analysis. These 4 trials randomised 12,456 patients to either intensive blood pressure targets or standard blood pressure targets. Intensive blood target was defined as SBP <120 mmHg in 2 trials, and as SBP <130 mmHg in 2 trials. The meta-analysis showed that intensive blood pressure control was associated with reduced MACE (OR 0.69, 95%CI 0.58-0.83), acute coronary syndrome (OR 0.70, 95% CI 0.55-0.90), heart failure (OR 0.55, 95% CI 0.37-0.80), and stroke (OR 0.65, 95% CI 0.49-0.86). Similar trend was observed with all-cause mortality (OR 0.81, 95%CI 0.64-1.01) and cardiovascular mortality (OR 0.67, 95%CI 0.44-1.02), although not statistically significant. In terms of adverse effects, intensive blood pressure control was significantly associated with increased hypotension compared to standard blood pressure targets: OR 1.32 (95% CI 1.06-1.65, p=0.01). However, there was no significant difference in falls, syncope, or acute kidney injury between the two groups.

Conclusion

While the evidence base is limited, this analysis suggests that intensive blood pressure target may be a beneficial strategy in reducing the risk of cardiovascular events in the elderly population with hypertension. More studies are needed to evaluate the impact of this strategy on mortality and on the adverse side effects in older populations.Outcome: strokeOutcome: mortality
The risk of severe coronary artery disease in prediabetes among the hypertensions --UPPDATE STUDY
Authors: Bao L W , Yong L , Ying S H A N
Published: November 2023

Backgrounds and Objectives

Hypertension and type 2 diabetes (DM) have become the major public health problems around the world and the concurrence of both diseases leads to more than triple risks developing ASCVD. However, in addition to type 2 diabetes, the diagnosis and treatment of prediabetes (preDM) status acquires more attention in these years. Among these issues, the risks of severe coronary artery disease in prediabetes concurrent with hypertension remains unknown. We sought to evaluate the association of prediabetes and severe coronary artery disease in hypertensions and to propose treatment suggestions using UPPDATE study data.

Methods

The national cross-sectional study-UPPDATE comprised of 8548 eligible hypertension subjects from 36 cities in China during 2017 to 2019. After consent form assigned, all enrolled hypertensives would undergo a clinical survey and clinical assessment, patients were also required to provide biomedical reports within one-year from his/her visit to outpatient department. Patients with severe coronary stenosis was defined as more than 70% stenosis in more than one coronary artery and underwent percutaneous coronary intervention (PCI). Diagnosis of preDM was based on patients’ HA1bc level ranging from 5.7% to 6.4%. Stata 13.0 was used for statistical analysis.

Results

Among 8548 hypertensives, 20.38% were diagnosed with diabetes and treated on hypoglycemic therapy,19.2% with HA1bc recorded (1658) can be classified into preDM according to previous definition. 1.76% of 4268 patients who reported ASCVD history had PCI before and 1123 of them provide HA1bc data within one-year from visit. Compared with patients without diabetes, preDM(Odds ratio 6.27, p=0.09 (95%CI 0.81-52.82)) and DM(Odds ratio 5.72, p=0.12 (95%CI 0.62-51.14)) showed significant association with severe coronary artery disease with PCI treatment. 63% preDM and 73% DM patients were undergoing anti-lipid therapy (p<0.05) and LDL-C level was 2.81±0.69mmol/L and 2.79±0.51mmol/L respectively (p=0.82). In multivariate regression analysis, systolic and diastolic blood pressure greater than 140mmHg and 80mmHg had higher risks of PCI treatment in preDM patients compared with the hypertensives without DM.

Conclusion

Compared with patients without diabetes, hypertension patients with preDM were associated with higher risks of severe coronary artery disease. Systolic and diastolic blood pressure should be controlled more strictly in preDM patients with hypertension to prevent severe coronary artery disease.
Cardiovascular and metabolic effects of MANP. a novel GC-A activator, in human hypertension with metabolic syndrome
Authors: Ma X , Mckie P , Iyer S , Scott C , Bailey K , Johnson B , Benike S , Chen H , Miller W , Cabassi A , Burnett J , Cannone V
Published: November 2023

Background/Introduction

Hypertension (HTN) and metabolic syndrome (MetS) are both leading risk factors for major cardiovascular diseases, which frequently coexist as a complicated cardiometabolic disorder. The cardiac hormone atrial natriuretic peptide (ANP) plays a key role in both blood pressure and metabolic regulation through activation of the guanylyl cyclase-A receptor (GC-A) and the second messenger 3’,5’ cyclic guanosine monophosphate (cGMP). Indeed, ANP decreases blood pressure, induces lipolysis by increasing plasma levels of non-esterified fatty acids (NEFA) and improves insulin-sensitivity. MANP is a new Mayo Clinic designed natriuretic peptide consisting of the native ANP with a 12-amino-acid C-terminus extension and its biological actions are mediated by the GC-A/cGMP pathway. MANP is less susceptible to neprilysin degradation and exert more sustained cGMP dependent biological actions than ANP.

Purpose

In a proof-of-principle human study, for the first time we aimed to determine the cardiovascular and metabolic properties of MANP, a novel ANP analog, in the clinical setting of HTN with MetS.

Methods

We conducted a double-blind, placebo-controlled trial in 22 patients (17 receiving MANP) with HTN and MetS involving single subcutaneous injection of MANP (2.5 µg/kg) or placebo (NCT03781739). Blood pressure (BP) and circulating cGMP were monitored for 24 hours post treatment. Circulating metabolic parameters including insulin, glucose, non-esterified fatty acids (NEFA) and insulin resistance (HOMA-IR) and insulin sensitivity (HOMA-IS) indexes were assessed for the first 4 hours post treatment.

Results

Compared to baseline, MANP increased plasma cGMP at 30 minutes (delta: 4.8 ± 2.0 pmol/mL, P = 0.02) and 1 hour (delta: 2.9 ± 1.3 pmol/mL, P = 0.03) post injection. At 6 hours, systolic BP decreased by 5.7 ± 2.9 mmHg (P = 0.06) in the MANP group, whereas no reduction in BP was observed in placebo group. Among the 17 subjects receiving MANP, lower baseline cGMP levels were associated with greater mean reductions in systolic BP (ρ = 0.66, P = 0.005). After MANP injection, glucose levels decreased at 2 (delta: -4.7 ± 2.1 mg/mL, P = 0.04) and 4 hours (delta: -13.1 ± 3.9 mg/mL, P = 0.003) compared to baseline while insulin levels remained stable. During the first 4 hours post injection, we also observed a trend of increase in insulin sensitivity index (HOMA2-IS) and decrease in insulin resistance index (HOMA2-IR) with MANP, both were opposite to the trends in placebo. At 1 hour post MANP administration, NEFA increased by 108.2 ± 37.4 µM compared to baseline (P = 0.01).

Conclusion(s)

Our findings support the favorable cardiovascular and metabolic actions of MANP as a potential therapeutic strategy for HTN with MetS.