bluuebunny/crossref_metadata_2025 huggingface dataset:
Baseline hemoglobin and bleeding risk in patients with myocardial infarction treated with PCI
Authors: Kanic V , Kompara G , Naji F.H
Published: November 2020

Background

Bleeding is one of the major complications of the modern treatment of myocardial infarction (MI). The data on admission hemoglobin (aHb) and bleeding in patients with MI who underwent percutaneous intervention (PCI) are scarce.

Purpose

We aimed to investigate the association between the graded aHb level and hospital bleeding in patients with MI who underwent PCI.

Methods

A single-center retrospective study was performed at our university, a tertiary referral hospital with a 24/7 PCI service. We analyzed 7315 MI patients. The patients were treated according to the published guidelines for the management of MI. The PCI strategy and concomitant medication were left to the discretion of the operator and the attending physician. The groups, stratified at 10g/L intervals according to the Hb level on admission, were compared. The criteria of the Bleeding Academic Research Consortium (BARC) 3a bleeding (an aHb drop of 30–50 g/L or any transfusion) were used. Data were analyzed using descriptive statistics. The interval with the most patients (130–139 g/L) was used as the reference group. The aHb value was used not only as a categorical variable but also as a continuous variable.

Results

The rates of bleeding were significantly higher in the groups with lower baseline aHb compared to the groups with higher aHb levels (p<0.0001). A nonlinear inverse relationship was observed between the aHb and bleeding (Figure 1). Higher values of aHb were associated with a lower risk of bleeding (adjusted OR 0.76; 95% CI 0.72 to 0.81; p<0.0001). We observed that there was an ∼7.5-fold and an ∼2-fold lower odds of bleeding in the lowest aHb level groups (<100g/L and 100–109 g/L) compared to the reference group, respectively (adjusted OR 7.54; 95% CI 5.38 to 10.56; p<0.0001 and 2.01; 95% CI 1.38 to 2.92) after adjustment for potential confounders. Patients with aHb levels equal to or greater than 110 g/L had a similar bleeding risk to the reference group.

Conclusion

We found that a graded decrease in the aHb level is associated with a progressively increased risk of hospital bleeding. Patients with aHbs lower than 110 g/L are particularly prone to bleed. Up to now, no consensus has been reached as to whether interventions aimed at correcting anemia could improve the outcome in these patients. Therefore, preventive measures to minimize additional bleeding (radial access, thinner sheaths, the use of selective GPIIb/IIIa receptor antagonists, proton-pump inhibitors) should be used. Even bare-metal stents may be selected, based on the evaluation of the bleeding/thrombosis risk for each patient. In general, the lower the aHb, the greater the bleeding risk.

Admission Hb and bleeding

Funding Acknowledgement

Type of funding source: None
Diabetic patients treated with novel thin composite-wire strut zotarolimus-eluting stents versus ultrathin strut sirolimus-eluting stents in the BIONYX trial: 2-year results of a prespecified analysis
Authors: Ploumen E , Buiten R.A , Zocca P , Roguin A , Doggen C.J.M , Jessurun G.A.J , Schotborgh C.E , Danse P.W , Benit E , Aminian A , Van Houwelingen K.G , Stoel M.G , Hartmann M , Linssen G.C.M , Von Birgelen C
Published: November 2020

Background/Introduction

The novel thin composite-wire strut zotarolimus-eluting stent (ZES) is a drug-eluting stent that is frequently used for treating patients with obstructive coronary artery disease, but so far no clinical outcome data have been published in patients with diabetes. In all-comer patients, the BIONYX trial (NCT02508714) has established non-inferiority of the ZES versus the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES) regarding the primary composite endpoint of target vessel failure at 1 year follow-up.

Purpose

To assess in patients with diabetes, the 2-year safety and efficacy of the current generation thin composite-wire strut ZES, compared to the ultrathin strut SES.

Methods

In the international, multicentre BIONYX trial, randomisation was stratified for sex and the presence of diabetes mellitus. We performed a prespecified subgroup analysis of patients with diabetes. The main endpoint target vessel failure was a composite of safety and efficacy, consisting of cardiac death, target vessel-related myocardial infarction or clinically indicated target vessel revascularisation. Secondary endpoints, such as target lesion revascularisation and stent thrombosis were also assessed.

Results

A total of 510/2488 (20.5%) BIONYX trial participants had diabetes, and were therefore included in this analysis. Patients were on average 66.4±10.3 years old, and 28.6% were female. Most participants presented with acute coronary syndromes (65.1%), and 182/510 (35.7%) patients were insulin dependent. Two-year follow up was available in 500 of 510 (98.0%) patients. Target vessel failure occurred in 31/260 (12.2%) patients assigned to ZES versus 26/250 (10.7%) patients assigned to SES (HR 1.14, 95%-CI 0.68–1.92; P-logrank=0.63). Kaplan Meier curves of target vessel failure are displayed in Figure 1. There were no significant between-stent differences in the individual components of this endpoint. Target lesion revascularisation occurred in 15/260 (6.0%) patients treated with ZES versus 9/250 (3.7%) patients treated with SES (HR 1.61, 95%-CI 0.71–3.68; P-logrank=0.25). Definite stent thrombosis was an infrequent event and did not differ significantly between stent-arms (0.4% vs. 1.2%; HR 0.32, 95%-CI 0.03–3.06; P-logrank=0.30).

Conclusion

In patients with diabetes, the novel thin composite-wire strut durable polymer ZES was similarly safe and efficacious as compared to the ultrathin cobalt-chromium strut biodegradable-polymer SES at 2-year follow-up.

Figure1. Target vessel failure at 2 years

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): The BIONYX trial was equally funded by Biotronik and Medtronic.
A new approach to the treatment of post-catheterization pseudoaneurysms by ultrasound-guided tissue glue injection or ultrasound-guided thrombin injection depending on a late to early velocity index
Authors: Zandecki L , Kurzawski J , Jaroszynska A , Piatek L
Published: November 2020

Background

Ultrasound-guided thrombin injection (UGTI) is often the first-line treatment for iatrogenic post-catheterization pseudoaneurysms (psA). There are reports of the use of biologically-derived tissue glues (TG) instead of sole thrombin especially when UGTI was unsuccessful or in case of psA recurrence. TG are more potent procoagulants and may increase the procedure success rates at the cost of higher risk of complications in case too much substance escape into the patient's circulation during the procedure. TG are also more expensive than thrombin so they are often reserved for selected patients.

We have previously identified a late to early velocity index (LEVI) <0.2 as a predictor of an increased risk of psA recurrence after standard UGTI. In the current paper we report our first experiences when the choice of the first-line treatment method was based on LEVI.

Methods

From May 2017 till January 2020 we included 36 patients with psA. Of them, 10 had LEVI <0.2 and they underwent ultrasound-guided tissue glue injection (UGTGI) and 26 had LEVI >0.2 and underwent UGTI. The injection set (containing human thrombin and fibrinogen) was used for UGTGI. Bovine thrombin was used for UGTI.

Results

The success rate was 100% and no psA recurrence was detected during 2-week follow-up. It was significantly better when compared to the expected recurrence rates based on our previous 15 years of experience (0% vs. 13%, p=0.02). All complications were mild and transient and included clinical symptoms of paraesthesia, numbness, tingling, or pain. Their rates were comparable to the rates we previously reported. No significant differences in other characteristics were observed.

Conclusion

The approach to choose the first-line treatment method for iatrogenic psA based on LEVI is encouraging.

Two examples of LEVI calculations

Funding Acknowledgement

Type of funding source: None
Ischemic burden reduction after chronic total occlusion percutaneous coronary intervention related to patient prognosis
Authors: Schumacher S.P , Stuijfzand W.J , Everaars H , Van Diemen P.A , Bom M.J , De Winter R.W , Kamperman L , Kockx M , Hagen B.S.H , Raijmakers P.G , Van De Ven P.M , Van Rossum A.C , Opolski M.P , Nap A , Knaapen P
Published: November 2020

Background

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) leads to major reductions in ischemic burden. However, to date, studies investigating if more ischemia reduction after CTO PCI translates into an improved patient prognosis, are lacking.

Purpose

To evaluate if change in absolute myocardial perfusion after CTO PCI is related to patient prognosis.

Methods

Between 2013–2019, 219 prospectively recruited patients with a CTO underwent quantitative [15O]H2O positron emission tomography perfusion imaging before and 3 months after successful CTO PCI in a single high-volume CTO PCI center (175 procedures/year). Changes in perfusion defect size (in myocardial segments) and hyperemic myocardial blood flow (MBF, in mL min–1 g–1) within the CTO territory after PCI were related to the combined endpoint of death or myocardial infarction (MI). Kaplan-Meier curves (log-rank test) and multivariable Cox regression (including covariates age, gender, prior MI, and left ventricular function) were used to analyze unadjusted and risk-adjusted event-free survivals with HR [95% CI].

Results

Out of 213 (97%) patients with a median follow-up of 3.2 [2.1–4.7] years, 22 (10%) patients experienced the composite of death (19, 9%) or MI (5, 2%). Event-free survival was significantly improved in patients with a perfusion defect size reduction of ≥3 segments (N=132, 62%) after CTO PCI compared to <3 segments (p=0.01, risk-adjusted: p=0.02 with HR 0.36 [0.15–0.87]), as well in patients with increase in hyperemic MBF above the median of the population (delta >1.13 mL min–1 g–1) as compared to below the median (p<0.01, risk-adjusted: p=0.01 with HR 0.27 [0.10–0.75]). After PCI, patients with ≥1 segment residual perfusion defect size in the CTO territory at follow-up (N=114, 54%) had a significantly worse event-free survival compared to patients with no residual defect size (p<0.01, risk-adjusted: p=0.01 with HR 4.12 [1.35–12.59]), whereas patients with a residual hyperemic MBF >2.30 mL min–1 g–1 (N=105, 49%) showed a better event-free survival compared to patients with lower residual hyperemic MBF levels (p=0.02, risk-adjusted: p=0.04 with HR 0.33 [0.12–0.95]).

Conclusions

Patients with more ischemic burden reduction and less residual ischemia following CTO PCI showed a major improved survival free of death or MI. A limitation was the low absolute number of events that prohibited more extensive risk-adjustment of the analyses.

Funding Acknowledgement

Type of funding source: None
Anticoagulation profile of high-dose vs. standard-dose enoxaparin for percutaneous coronary intervention
Authors: Liu Z , Chen Q , Li J , Zhu X , Xu L , Wu W
Published: November 2020

Background

Although enoxaparin 0.5 mg/kg is a recommended anticoagulation regimen for percutaneous coronary intervention (PCI), a randomized study demonstrated that more patients receiving enoxaparin 0.75 mg/kg compared to those receiving 0.5 mg/kg achieved therapeutic anticoagulation without increase of major bleeding. However, no detailed data regarding the anticoagulation profile of enoxaparin 0.75 mg/kg was reported in the study.

Purpose

This study prospectively assessed the anticoagulation profile of enoxaparin 0.75 mg/kg vs. 0.5 mg/kg in troponin-negative patients undergoing elective trans-radial coronary angiography (CAG).

Methods

Eligible patients were randomly assigned to the Planned Single-dose group (0.75 mg/kg) or the Planned Staged-dose group (0.5±0.25 mg/kg). In the Planned Single-dose group, all patients received enoxaparin 0.75 mg/kg before CAG irrespective of their indication for subsequent PCI. In the Planned Staged-dose group, enoxaparin 0.5 mg/kg was administered to all patients before CAG and additional 0.25 mg/kg was given only to those undergoing subsequent PCI immediately before PCI. Patients without indication for subsequent PCI in each group were defined as High-dose (0.75 mg/kg) and Standard-dose (0.5 mg/kg) groups, respectively. Anti-Xa levels were assessed at 0 min (immediately before), 10 min, and 90 min after enoxaparin administration. Therapeutic anticoagulation was defined as anti-Xa level of 0.5–1.8 IU/ml. Bleeding was according to the thrombolysis in myocardial infarction (TIMI) criteria.

Results

In 170 randomized patients, 48 of 85 patients in the Planned Single-dose group and 47 of 85 patients in the Planned Staged-dose group were included in the High-dose and Standard-dose groups, respectively. The baseline characteristics were well balanced between the two groups. The anti-Xa levels were higher in the High-dose vs. Standard-dose group both at 10 min (1.354±0.228 IU/ml vs. 0.976±0.213 IU/ml, p<0.001) and 90 min (0.827±0.195 IU/ml vs. 0.583±0.169 IU/ml, p<0.001) (Figure 1). The percentages of patients with therapeutic anticoagulation were similar at 10 min (100% [46/46] vs. 100% [46/46], p=1.000) but higher at 90 min (100% [41/41] vs. 75% [33/44], p=0.001) in the High-dose vs. Standard-dose group. No TIMI major or minor bleeding occurred within 24 h of randomization in both groups.

Conclusions

Enoxaparin 0.75 mg/kg compared to 0.5 mg/kg provided higher anticoagulation which was adequate for up to 90 min of administration. Enoxaparin 0.75 mg/kg would be a superior anticoagulation regimen for PCI, especially when the procedure duration is long.

Figure 1. High-dose vs. Standard-dose

Funding Acknowledgement

Type of funding source: Public hospital(s). Main funding source(s): 2016 Peking Union Medical College Hospital (PUMCH) Science Fund for Junior Faculty
Thirty-day incidence of stroke after transcatheter aortic valve implantation: a meta- and network meta-analysis comparing self-expandable versus balloon-expandable valve prostheses
Authors: Seppelt P.C , Mas-Peiro S , De Rosa R , Murray I , Fichtlscherer S , Zeiher A.M , Vasa-Nicotera M
Published: November 2020

Introduction

Stroke is a major and feared complication after transcatheter aortic valve implantation (TAVI). So far it is unknown, weather the valve deployment system itself has an impact on the incidence of periinterventional stroke. We sought to identify the incidence of 30-day stroke after transfemoral TAVI with self-expandable (SE) and balloon-expandable (BE) valves and performed a meta- and network meta-analysis to analyze differences related to the valve deployment system.

Methods

Overall 2706 articles were searched comparing directly the performance of SE and BE TAVI valves, from which 7 were included for analysis (one randomized controlled trial, 6 propensity score matching studies) with a total number of 2488 patients. Meta-analysis used random effects model and reported risk ratios (RRs). To compare different type of valves a random-effects network meta-analysis based on a frequentist framework for indirect and mixed comparisons was applied and reported odds rations (ORs). Using P-Score the relative ranking probability of each valve was estimated and the hierarchy of competing valves was obtained.

Results

Thirty-day incidence of stroke was 1.9% in SE (22 out of 1139, Medtronic CoreValve, Medtronic Evolut R and Pro, Boston Scientific ACURATE neo and St. Jude Medical Portico) and 3.1% in BE TAVI valves (42 out of 1349, Edwards Sapien 3 and XT) resulting in a RR of 0.65, (95% confidence interval (CI) 0.51 to 0.82). In accordance with the estimated P-Score CoreValve was the best effective for a reduction of 30-day stroke (72,5%) whereas the worst were Sapien 3 and XT (19.%). Combined direct and indirect evidence showed no superiority of CoreValve compared with Sapien valves (OR 0.469, 95% CI 0.13–1.64) concerning 30-day stroke incidence.

Conclusion

Our meta-analysis indicates a higher thirty-day incidence of stroke after TAVI with BE valves compared to SE valves. Furthermore, we could not find evidence for superiority of a specific valve system. Randomized controlled trials with head to head comparison of SE and BE valves are needed to address this open question.

Funding Acknowledgement

Type of funding source: None
Diabetes mellitus in transfemoral transcatheter aortic valve implantation in 11,440 patients from the CENTER collaboration
Authors: Van Nieuwkerk A.C , Santos R.B , Blanco Mata R , Tchethce D , De Brito F.S , Kornowski R , Latib A , Oteo-Dominguez J , Dumonteil N , D'Errigo P , Tarantini G , Lunardi M , Dangas G , Baan J , Delewi R
Published: November 2020

Background

Diabetes mellitus (DM) is a well-known cardiovascular risk factor present in up to a third of patients undergoing transcatheter aortic valve implantation (TAVI). How DM might influence outcomes after TAVI procedures remains controversial. The aim of this study was to determine differences in outcomes after TAVI according to diabetes status.

Methods

The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVI from 2007 to 2018. In this analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between DM and non-DM patients.

Results

Of the 11,440 patients included, 31% (n=3,550) were diabetic and 69% (n=7,890) were non-diabetic. Diabetics were younger, had a higher body mass index (BMI) and overall a worse cardiovascular risk profile than non-diabetics. There were no differences between DM and non-DM patients regarding in-hospital mortality (4.8% vs 5.3%, RR: 0.9, 95% CI: 0.7–1.1, p=0.46), myocardial infarction (0.9% vs 0.7%, RR: 1.4, 95% CI: 0.9–2.2, p=0.17), stroke (1.7% vs 2.0%, RR: 0.9, 95% CI: 0.6–1.2, p=0.36), major or life threatening bleeding (5.9% vs 6.3%, RR: 0.9, 95% CI: 0.8–1.1, p=0.44) and permanent pacemaker implantation (13.6% vs 13.4%, RR: 1.0, 95% CI: 0.9–1.1, p=0.69). Similarly, 30-day rates of all-cause mortality (5.4% vs 6.1%, RR: 0.9, 95% CI: 0.8–1.1, p=0.30) and stroke (2.0% vs 2.4%, RR: 0.8, 95% CI: 0.6–1.1, p=0.23) did not differ between diabetic and non-diabetic patients. Accordingly, in multivariate analysis, DM was not an independent predictor of mortality.

Conclusions

In this global collaboration, diabetic patients undergoing transcatheter aortic valve replacement had more cardiovascular comorbidities, were younger and had a higher body mass index than non-diabetics. They had similar periprocedural complications, in-hospital and 30-day mortality rates. In multivariate analysis, diabetes was not associated with increased mortality.

Predicted vs observed mortality in DM

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): Dutch Heart Foundation; the Netherlands Organisation for Health Research and Development
Post TAVR coronary revascularization guided by stress cardiac imaging and impact on cardiovascular events
Authors: Lattuca B , Prunet E , Huet F , Akodad M , Manna F , Macia J.C , Schmutz L , Gandet T , Cayla G , Leclercq F
Published: November 2020

Background

The prognostic impact of systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is still debated

Purpose

The main objectives of this study were to evaluate the feasibility and the safety of a functional evaluation of coronary artery disease (CAD) followed by a selective ischemia-guided percutaneous coronary intervention (PCI) after TAVR.

Methods

This prospective, bi-centric, one-arm, open-label trial included patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as one or more coronary stenosis ≥70%. Patients with left main stenosis ≥50%, proximal left anterior descending artery (LAD) stenosis ≥90% or > class 2 Canadian cardiovascular society angina pectoris were excluded. Coronary revascularization was not performed before TAVR and myocardial ischemia was evaluated by stress cardiac imaging one month after the procedure using Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging or Stress Echocardiography using dobutamine infusion. The primary endpoint was the composite of all cause of death, stroke, major bleeding (Bleeding Academic Research Consortium (BARC) ≥3), major vascular complication (Valve Academic Research Consortium 2 criteria), myocardial infarction (MI) and hospitalization for cardiac causes at 6 months following TAVR.

Results

Between June 2016 and March 2019, 71 patients were included with a complete follow-up in 66 patients. The mean age was 84±5.2 years and the mean Euroscore was 13±8.6. Stress cardiac imaging could be achieved in 70% (n=46) of the patients and the main causes to not perform it were patient refusal or secondary impaired medical condition. Significant myocardial ischemia was observed in only 3 patients (4.5%), of whom 2 patients had successful PCI. The primary endpoint occurred at 6 months in 15 patients (23%) including death in 6 patients (9%), stroke in 3 patients (5%) and major bleedings in 3 patients (5%). Acute MI was observed in only 2 patients (3%) that had not-LAD proximal and severe coronary stenosis (≥90%). Hospital readmission (n=27, 41%) was mostly related to non-cardiac causes (n=18, 27%).

Conclusions

In patients scheduled to TAVR and with significant coronary disease, a strategy of selective ischemia-guided coronary revascularization after TAVR appears safe with a low rate of myocardial infarction and myocardial ischemia requiring revascularization during follow-up. However, the poor adherence of elderly patients to stress test could suggest to perform PCI of proximal and severe coronary lesions. Large-scale and randomized trials are warranted to validate this strategy.

Funding Acknowledgement

Type of funding source: None
How safe are current expert consensus recommendations for discharge after TAVI?
Authors: De Torres Alba F , Kaleschke G , Vormbrock J , Reinecke H , Deschka H , Baumgartner H
Published: November 2020

Introduction

How long patients (pts) remain at risk to develop conduction abnormalities (CAs) requiring pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI) and should therefore be monitored remains controversial. A recently published Expert Consensus Document (CD) proposes an ECG-based algorithm to risk-stratify patients and suggests early discharge of patients with low risk. Our institutional policy is to monitor all patients without previous PM for at least 7 days. We aimed to apply the discharge recommendations of this algorithm retrospectively to our patient cohort with prolonged and well documented ECG monitoring post-TAVI to evaluate the safety of this strategy.

Methods

We studied the development CAs in 1447 consecutive patients treated with Sapien 3 between January 2014 and December 2019. After excluding valve-in-valve procedures (n=30) and pts with previously implanted PM (n=167) 1254 remained for this analysis.

Results

Of 1254 pts, 159 (12.7%) developed high grade CAs requiring PM implantation after TAVI. 808 (64%) had no pre-existing right bundle branch block (RBBB) and no ECG changes immediately post-procedure (CD Group 1, hospital discharge recommended at day 1 post TAVI). Of these pts, 50 (6%) developed high grade CAs within the first 24 hours (h) after TAVI but 31 (3.8% of Group 1) after 24h (Figure 1, Panel A). 111 (8.9%) pts had pre-existing RBBB and no new ECG changes after TAVI (CD Group 2, hospital discharge recommended at day 2 post TAVI). In this group 27 pts (24%) developed high grade CAs within the first 48h after TAVI but 14 (12.6%) after 48h (Figure 1, Panel B). 62 pts had pre-existing CAs and had ECG-changes (CD Group 3, hospital discharge recommended at day 2 post TAVI if no progression). In this group 9 (14%) developed high grade CAs within the first 48h after TAVI but 5 (8%) after 48h (Figure 1, Panel C). 212 (17%) patients had a new-onset left bundle branch block (LBBB) after TAVI (CD Group 4, hospital discharge recommended at day 2 post TAVI if resolution/no progression); of these pts, 7 (3.3%) developed high grade CAs within the first 48h after TAVI and 13 (6.1%) after 48h (Figure 1, Panel D).

Conclusion

In this large TAVI cohort with a PM implantation rate of 12.7%, 40% of pts (5% of the entire population) would have been already discharged at the time they developed their CA when following recently published expert consensus recommendations. These results question the safety of the recommended early discharge algorithm and support a more conservative strategy.

Figure 1

Funding Acknowledgement

Type of funding source: None
Association of the get with the guidelines heart failure risk score with mortality in patients undergoing transcatheter edge-to-edge mitral valve repair
Authors: Iliadis C , Metze C , Spieker M , Kavsur R , Horn P , Westenfeld R , Tiyerili V , Becher M.U , Kelm M , Nickenig G , Baldus S , Pfister R
Published: November 2020

Background

Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients.

Methods

Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the “Get with the Guidelines Heart Failure Risk Score” (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of COPD) with all-cause mortality.

Results

Among 815 patients with available data 177 patients died during a mean follow-up time of 419 days. Estimated one-year mortality by quartiles of the score (0–37; 38–42, 43–47 and more than 47 points) was 6%, 10%, 23% and 30%, respectively (p<0.001). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06–1.11%, p<0.001). The score was associated with long-term mortality independently of left ventricular ejection fraction, renal function and LogEuroscore, and was equally predictive in primary and secondary mitral regurgitation.

Conclusion

The “Get with the Guidelines Heart Failure Risk Score” showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible.

Funding Acknowledgement

Type of funding source: None
Incidence of intravascular hemolysis after transcatheter mitral valve repair
Authors: Paulus M , Meindl C , Hamerle M , Schach C , Maier L.S , Birner C , Debl K , Unsoeld B
Published: November 2020

Background

Chronic subclinical intravascular hemolysis is a common complication after valve replacement associated with worse prognosis, occurring in up to 80% of patients after mitral valve surgery. While serious intravascular hemolysis after MitraClip implantation has been reported anecdotally, data on the impact of transcatheter mitral valve repair on the prevalence of subclinical hemolysis are lacking.

Methods and results

From August 2017 to November 2019, 77 patients with high perioperative risk and moderate-to-severe or severe mitral regurgitation were prospectively enrolled in a single-center trial. All participants were treated with transcatheter edge-to-edge mitral valve repair using the MitraClip NT, NTR or XTR system. Before and three months after the procedure, all patients underwent comprehensive clinical assessment including laboratory measurement of hemoglobin, haptoglobin and lactic acid dehydrogenase in venous blood samples. Presence of subclinical intravascular hemolysis was defined as hemoglobin <13.8 g/dl for males or <12.4 g/dl for females, haptoglobin <65 mg/dl and lactic acid dehydrogenase >250 U/l. Levels of the hemolysis marker haptoglobin significantly decreased three months after the intervention (127±71 mg/dl at three months vs. 158±73 mg/dl at baseline, p<0.001), accompanied by an increase in lactic acid dehydrogenase (251±88 U/l vs. 222±55 U/l, p<0.01), implying the induction of intravascular hemolysis by transcatheter mitral valve repair. Higher residual mitral regurgitation was associated with lower haptoglobin levels three months after mitral valve repair (p<0.05), hinting that shear stress caused by regurgitation flow is the primary mechanism for hemolysis after MitraClip implantation. Concurrently, we observed a trend towards an increase in the presence of subclinical intravascular hemolysis (9.1% at three months vs. 3.9% at baseline, p=0.289). Hemoglobin levels remained unchanged (12.1±1.5 g/dl at three months vs 12.3±1.8 g/dl at baseline, p=0.107). No patient needed treatment for intravascular hemolysis.

Conclusion

Transcatheter edge-to-edge mitral valve repair in a high-risk collective is associated with the induction of hemolysis. Yet, prevalence of subclinical intravascular hemolysis is low when compared to mitral valve surgery, emphasizing the good safety profile of minimal-invasive mitral valve therapy.

Funding Acknowledgement

Type of funding source: Public Institution(s). Main funding source(s): ReForM-B research grant, University of Regensburg
Can double internal thoracic artery grafts affect 10-year outcomes after coronary artery bypass grafting?
Authors: Barili F , D'Errigo P , Rosato S , Biancari F , D'Ovidio M , Pagano E , Seccareccia F
Published: November 2020

Background

The advantages of the employment of double internal thoracic artery grafts (BITA) for coronary artery bypass grafting have been recently questioned and no data on long-term follow-up are available. This observational retrospective cohort study was designed by the PRIORITY planning committee to evaluate 10-year follow-up of isolated CABG performed with and without BITA in order to clarify and consolidate the contrasting literature.

Methods

The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002–2004 and 2007–2008. Data on isolated CABG were linked to 2 administrative datasets. Time-to-event distributions were separately analyzed accordingly to primary event-type (death, MACEs), using Kaplan-Meier estimates and Cox regression.

Results

The population consisted of 11021 patients who underwent isolated CABG that were divided into development and validation datasets; double thoracic internal artery grafts was employed in 24.6%. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. After adjustment for potential confounding factors, BITA was significantly associated with better survival (HR 0.85, 95% CI 0.76–0.95, p=0.003). Moreover, the employment of BITA reduced the incidence of MACEs at follow-up (adjusted HR 0.87, 95% CI 0.80–0.94, p=0.001). In details, BITA was demonstrated to be a protective factor for acute myocardial infarction (adjusted HR 0.84, 95% CI 0.71–0.99, p=0.05) and for rehospitalization for percutaneous cardiac intervention (PCI; adjusted HR 0.82, 95% CI 0.70–0.96, p=0.013).

Conclusions

The employment of double internal thoracic artery grafts for coronary artery bypass grafting has been associated to survival advantage at 10-year. Moreover, it significantly decreased the incidence of acute myocardial infarction and rehospitalization for percutaneous cardiac intervention.

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health
Earlier surgery improves long-term survival compared to class I surgical indications and infective endocarditis surgery for isolated severe tricuspid regurgitation
Authors: Wang T.K.M , Akyuz K , Xu B , Gillinov M , Pettersson G , Griffin B.P , Desai M.Y
Published: November 2020

Background

Isolated tricuspid surgery has markedly higher mortality rates (9–10%) in contemporary national registries compared to other single-valve operations. The optimal timing and indications remain controversial, and earlier surgery before developing ESC guidelines class 1 indications may improve the survival for isolated severe tricuspid regurgitation.

Purpose

We aimed to compare the characteristics and outcomes of isolated tricuspid regurgitation (TR) surgery by indication.

Methods

Consecutive patients undergoing isolated tricuspid valve surgery for TR without other concomitant valve surgery at Cleveland Clinic from 2004 to 2019 were studied. Indications were divided into group 1: ESC guidelines class 1 (severe symptomatic TR), group 2: infective endocarditis, and group 3: non-class 1 (asymptomatic severe TR with or without right ventricular dilation and/or dysfunction) and no endocarditis, for comparative analyses of characteristics and outcomes.

Results

The study included 207 patients (group 1: 115, group 2: 48 and group 3: 44) with mean age 54.1±17.8 years, 116 (56.0% females and 151. Tricuspid repair was performed in 72.9% (73.0%, 66.7% and 79.5% for Groups 1–3, P=0.381). Group 3 patients were younger, had higher prevalence of primary TR, lower prevalence of heart failure, atrial fibrillation, chronic lung disease, cirrhosis, renal impairment, right ventricular and left ventricular dysfunction than Group 1. Overall operative mortality rates were 4.9% ( group 1: 7.0%, group 2: 4.2% and group 3: 0.0%), while mortality during follow-up of 3.3±4.0 years was lower for group 3 than for groups 1 or 2 (Figure 1). Independent predictors of long-term mortality were Group 1 compared to Group 3 and reduced estimated glomerular filtration rate.

Conclusion

Patients without class I or endocarditis indications had superior unadjusted and adjusted survival compared to those with these indications. The high mortality rate of isolated TR surgery may be reduced by both earlier surgery and being performed at an experienced cardiac surgery center.

Figure 1. Kaplan-Meier survival curves

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): National Heart Foundation of New Zealand - Overseas Clinical and Research Fellowship
One-month results from a prospective experience on CAS using C-GUARD stent system: the IRONGUARD-2 study
Authors: Sirignano P , Stabile E , Stabile E , Mansour W , Mansour W , Speziale F , Speziale F
Published: November 2020

Objectives

To evaluate 30-day safety and efficacy of dual layered mesh covered carotid stent systems (DLS) for carotid artery stenting (CAS) in the clinical practice.

Background

When compared to carotid endarterectomy CAS has been associated to an higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of DLS.

Methods

From January 2017 to June 2019 a physician-initiated, prospective, multispecialty, registry enrolled 733 consecutive patients undergoing CAS using the CGuard Embolic Prevention System (EPS) in 20 centres. Primary endpoint was the stroke up to 30 days; secondary endpoints were the technical and procedural success; external carotid artery (ECA) occlusion; in-hospital and 30 days transient ischemic attack (TIA), acute myocardial infarction (AMI) and death rates.

Results

Symptoms were present in 131 patients (17.87%). An embolic protection device (EPD) was used in 731 patients (99.72%). Procedural success was 100%, technical success was obtained in all but one patient (99.86%), who died in-hospital due to a haemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, ECA occlusion was evident in 8 patients (1.09%). Between hospital discharge and 30-day, 2 TIAs, 1 minor stroke and 3 AMIs occurred. Therefore, the stroke rate at 30 days was 0.13.

Conclusion

This real-world registry suggests that use of CGuard EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 30 days follow up.

Funding Acknowledgement

Type of funding source: None
Long-term antihypertensive treatment improves ventricular-arterial interaction in hypertensive patients: a 3-year follow-up study
Authors: Ikonomidis I , Tzortzis S , Triantafyllidi H , Thymis J , Frogoudaki A , Vrettou A.R , Iliodromitis E
Published: November 2020

Background

We investigated the effects of antihypertensive treatment on vascular function, longitudinal deformation and ventricular-arterial interaction in hypertensives.

Methods

In 200 untreated patients with arterial hypertension (age 52.5±11.6 years, 56% females), we measured at baseline and after a 3-year of antihypertensive treatment (160 received ACEi± diuretics and 40 CCBs± diuretics): a) 24h ambulatory blood pressure b) Carotid-femoral pulse wave velocity (PWV) b) Coronary flow reserve (CFR), LV mass index (LVMI), the global longitudinal strain (GLS). We calculated the ratio of PWV/GLS (-m/sec%) reflecting the ventricular-arterial interaction.

Results

Compared to baseline, there was an improvement of GLS (−19.9±3.4 vs. −18.7±3.1%), post-treatment. In parallel, there were improvement in CFR (2.72±0.61 vs. 2.55±0.64), PWV (10.3±1.9 vs. 11.2±2.1 m/s), LVMI and PWV/GLS (−0.539±0.146 vs. −0.618±0.178 -m/sec%) (p<0.01 for all comparisons). By multivariate analysis, the reduction of 24h meanBP as well as PWV independently determined the respective improvement of GLS (b=0.478, b=0.248, respectively, p<0.001). By ANOVA, the interaction term between changes of all the above parameters and antihypertensive treatment (ACE inhibitors vs calcium channel blockers) was not significant (p>0.05).

Conclusions

Long-term optimal blood pressure control with ACE inhibitors and CCBs improves LV longitudinal deformation along with reduction of arterial stiffness, leading to improved ventricular-arterial interaction in hypertensives.

Funding Acknowledgement

Type of funding source: None
Association between comorbidities and blood pressure trajectories in patients with hypertension
Authors: Canoy D , Tran J , Norton R , Ayala Solares R , Conrad N , Nazarzadeh M , Raimondi F , Salimi-Khorshidi G , Rodgers A , Rahimi K
Published: November 2020

Background

Our knowledge of how to better manage elevated blood pressure in presence of comorbidities is limited; in part due to exclusion or underrepresentation of multimorbid patients from major clinical trials.

Purpose

To investigate the burden and types of comorbidities in patients with hypertension, to assess how such comorbidities and other variables affect blood pressure levels over time.

Methods

The study was conducted using linked electronic health records from the UK Clinical Practice Research Datalink study from its inception on 1 January 1985 to 30 September 2015. Using linked electronic health records, we compared systolic blood pressure levels among 295,487 patients with diagnosed hypertension by type and numbers of major comorbidities from at least 5 years before to up to 10 years after hypertension diagnosis. We used a multiple landmark cohort design in order to investigate associations prospectively with time-updated information that takes advantage of the dynamic nature of electronic health records.

Results

Time-updated multivariable linear regression analyses showed that the presence of more comorbidities was independently associated with lower blood pressure during follow-up. This negative association was not specific to particular types of comorbidities; although associations were stronger in those with pre-existing cardiovascular disease. Tracking patients backwards to years prior to hypertension diagnosis revealed that the association between comorbidities and blood pressure were even more pronounced in years before hypertension diagnosis. Despite substantial declines in blood pressure in the first year after diagnosis, subsequent changes were modest, with no evidence of a more rapid decline in those with more or specific types of comorbidities.

Conclusions

Blood pressure levels at which patients were diagnosed with hypertension varied substantially and were lower when patients had more comorbidities. This early selection bias was a key determinant of long-term differences in blood pressure by comorbidity status and provides an additional explanation for the lower blood pressure in multimorbid patients.

Mean SBP (mmHg) over time

Funding Acknowledgement

Type of funding source: Public Institution(s). Main funding source(s): National Institute for Health Research Oxford Biomedical Research Centre, Rhodes Trust and Clarendon Fund
Exercise duration as apredictor ofcardiovascular disease in arterial hypertension. Data from a 6-year follow-up study
Authors: Leontsinis I , Kasiakogias A , Mantzouranis M , Fragoulis F , Andrikou I , Tzorovili E , Tatakis F , Karaminas N , Kouremeti M , Manta E , Zammanis I , Antoniou C , Tousoulis D , Tsioufis C
Published: November 2020

Background

Current hypertension guidelines necessitate an individualized cardiovascular risk assessment through a process that includes several parameters and remains challenging. Exercise capacity has been strongly associated with prognosis in cardiovascular disease and can be easily assessed by the exercise treadmill test (ETT).

Purpose

The aim of the present study was to investigate theprognostic role of exercise capacity for future cardiovascular events in a cohort of essential hypertensive subjects.

Methods

We followed up 1037 hypertensive adults (mean age 56 years, 53% males) with no previous history of cardiovascular disease, for a mean period of 6±3 years. During the baseline visit all subjects underwent a complete echocardiographic study, office blood pressure measurements, ECG, routine blood testing and an ETT with a Bruce protocol.During follow-up, all subjects were reviewed at least annually. Exercise capacity was expressedwithexercise duration the distribution of which was split by the median (9min). Accordingly, the subjects were classified into those with high (51%) and low exercise capacity (49%). The cardiovascular endpoint of interest was the composite of coronary artery disease and stroke.

Results

The incidence of cardiovascular eventsduring the follow-up period was 4.1% (35 cases of coronary artery disease and 10 cases of stroke).Cox regression analysis revealed that high exercise capacity was associated with a lower risk for future cardiovascular events (HR = 0.35 (95% CI 0.172–0.741, p=0.006). In multivariate models adjusting for standard clinical and laboratory cardiovascular risk factors this association was sustained.

Conclusion

Exercise duration shows a significant prognostic value for future CV events among hypertensivepatients. Exercise capacity assessment by means of TTE could enhance the identification of asymptomatic hypertensives at higher risk.

Funding Acknowledgement

Type of funding source: None
Heart failure events in a clinical trial of arterial hypertension. The acquittal of the SPRINT trial
Authors: Sobieraj P , Kahan T , Nilsson P.M
Published: November 2020

Introduction

The Systolic Blood Pressure Intervention Trial (SPRINT) was a randomized trial showing that intensive lowering of systolic blood pressure (BP), as compared to standard treatment (i.e. <120 vs <140 mm Hg) was associated with a reduced risk (HR 0.75 [95% CI 0.64–0.79], p<0.001) for the primary composite outcome (CE), defined as myocardial infarction, an acute coronary syndrome other than myocardial infarction, stroke, acute exacerbation of heart failure and cardiovascular death. primary outcome event in subjects at high cardiovascular risk. However, the primary endpoint events in the intensive treatment arm were only 76 fewer than in the standard treatment arm (243 vs 319 events), and he reduction in heart failure events was responsible for half of the effect (62 vs 100 events, i.e. 38 events fewer). Thus, several experts in hypertension argued that these results were mainly driven by a reduction of heart failure events, and questioned the main conclusion of the study.

Aim

To assess the effect of SPRINT intervention on a redefined CE: the primary SPRINT endpoint with HF events excluded.

Material and methods

We used limited SPRINT data, available from the NHLBI Biologic Specimen and Data Repository to assess the impact of BP intervention in SPRINT on a redefined CE excluding HF events. The Chi-square test, Cox proportional model and survival analysis were applied.

Results

Among 9361 SPRINT participants (mean age 67.9±9.5 years, 35.6% female, 20% with previous cardiovascular disease), there was 461 CE events. There were fewer CE events in the intensive treatment arm than in the standard treatment arm (204 [4.4%] vs 257 [5.5%], p=0.0117, respectively). Intensive systolic BP lowering was associated with lower risk for CE than standard treatment (HR 0.79 [95% CI 0.66–0.95], p=0.0115). Kaplan-Meier curves show that intensive treatment was associated with better outcome (Figure 1). Analyses in subgroups (age >75 vs <75 years, female vs male, black vs non-black, prior cardiovascular disease vs no cardiovascular disease, prior chronic kidney disease vs no chronic kidney disease) showed no difference in benefit of intensive treatment (p for interaction >0.05 in all subgroup).

Conclusion

The reduction in cardiovascular events by intensive BP lowering in SPRINT was not explained by a difference in heart failure events. This supports the concept that more intensive BP reduction may provide benefit in reducing cardiovascular event risk.

Figure 1. Kaplan-Meier curves

Funding Acknowledgement

Type of funding source: None