bluuebunny/crossref_metadata_2025 huggingface dataset:
High bleeding risk mainly predicts non-access site bleeding events in the first month after percutaneous coronary intervention
Authors: Woelders E C I , Peeters D A M , Luijkx J J P , Winkler P J C , Damman P , Remkes W S , Van 'T Hof A W J , Van Geuns R J M
Published: November 2023

Background/Introduction

The majority of bleeding events after percutaneous coronary intervention (PCI) occur in the first month after PCI. To predict and anticipate on events during hospitalisation and in the first month, the CRUSADE- and ACUITY scores have been developed. In order to enhance the use of bleeding risk stratification, a consortium of PCI centres in the South East of the Netherlands has created and implemented a simple binary variant of the existing models. High bleeding risk (HBR) is defined by one of the following: eGFR< 30; anaemia (Hb < 7mmol/L); a spontaneous bleeding within one year before PCI; a history of intracranial haemorrhage.

Purpose

We evaluated the predictive value of our risk model and other risk factors for bleeding events in the first month after PCI and discriminated between access site- non-access site bleedings.

Methods

In an ongoing multicentre prospective PCI registry in the South East of the Netherlands collects baseline and follow-up data of all patients undergoing PCI. We compared access site- and non- access site bleedings between HBR and non HBR using the Kaplan Meier method and Cox regression. Also, we performed multivariate analysis of the separate factors of the model and other probable risk factors.

Results

We collected baseline and 30 day follow-up data in 3996 patients of which 357 with HBR (9%). Access site bleedings occurred in 3% of patients with HBR vs 2% without (sens. 0.13; spec. 0.98). Patients with HBR showed 5% non-access site bleedings versus 1% in non HBR (sens. 0.21; spec. 0.99). Survival curves and hazard ratios presented in figure 1 show that these differences are significant only for non-access site bleedings (HR: 4.2, 95% CI: 2.47-7.30). The multivariate analysis is presented in table 1. All bleeding events were predicted by age ≥ 60 and peripheral arterial disease. Furthermore, non-access site bleedings were predicted by anaemia and bleeding events in the previous year. Additional risk factors for access site bleedings were female sex and double access site punction.

Conclusion

The simplified risk model showed to be conservative in the determination of HBR as depicted by the sensitivity and specificity. However, it showed good discriminative value for non-access site bleedings which was driven by anemia and a history of bleedings. Furthermore, these results suggest that age ≥60 and peripheral arterial disease should be taken into consideration. Extra precaution for access site bleedings should also be taken in female patients and in the case of double access site punction.Figure 1Table 1
Distal radial approach using a transdermal nitroglycerin patch : double-blinded randomized trial
Authors: Murai K , Fujino M , Iwai T , Sawada K , Matama H , Miura H , Honda S , Yoneda S , Nakao K , Takagi K , Otsuka F , Kataoka Y , Asaumi Y , Tahara Y , Noguchi T
Published: November 2023

Background

The distal radial approach (DRA) provides a lower risk of radial artery occlusion than the conventional transradial approach (TRA) and has recently been used worldwide as an alternative access route for coronary catheterization. However, the small diameter of the distal radial artery causes difficulty in puncture and leads to DRA failure.

Purpose

The aim of this study is to elucidate whether a transdermal nitroglycerin patch improves the rate of successful DRA cannulation.

Methods

A total of 92 patients with angina pectoris scheduled for elective coronary angiography via DRA randomly received (1:1) a transdermal nitroglycerin patch pre-integrated with the covering material or only the covering material on their upper arm on the side of the puncture. The diameter of the distal radial artery was evaluated with ultrasound at baseline and after application. DRA procedures were performed in a double-blinded fashion. The primary outcome was the rate of successful palpation-guided distal radial artery cannulation with the first puncture.

Results

The nitroglycerin group had larger distal radial artery diameter after patch application than the no-treatment group (3.21 ± 0.68 mm vs. 2.71 ± 0.52 mm, P<0.001), but not at baseline (2.64 ± 0.48 mm vs. 2.64 ± 0.45 mm, P = 0.965, Figure 1).The nitroglycerin group had a significantly higher success rate of palpation-guided DRA cannulation with the first puncture than the no-treatment group (58.7% vs. 23.9%; P = 0.001; odds ratio, 4.5; 95% confidence interval, 1.9–11.0, Figure 2). Fewer punctures were required for successful sheath insertion in the nitroglycerin group compared with the no-treatment group (1 [1–5] vs. 3 [2–6]; P=0.019). Procedure time from puncture to sheath insertion was shorter in the nitroglycerin group, but the difference was not significant (142 [112–287] seconds vs. 202 [142–411] seconds; P=0.058). The incidence of vasospasm, hypotension (systolic blood pressure < 90 mmHg) before and during CAG, and puncture site hematoma was similar in the two groups. No patients experienced distal radial arterial occlusion.

Conclusions

The use of a transdermal nitroglycerin patch was associated with an increase in the diameter of the distal radial artery, higher success rate of DRA cannulation with the palpation-guided first puncture. The transdermal nitroglycerin patch has a potential to be an effective pretreatment for DRA.Changes in distal radial artery diameterResults of primary outcome
Double kissing inflation outside the stent versus jailed balloon technique for coronary bifurcation lesions
Authors: Yang H , Huang Z , Zhang F , Qian J , Ge J
Published: November 2023

Background

Side branch (SB) occlusion remains challenging in percutaneous coronary intervention (PCI) for bifurcation lesions even in the era of jailed balloon technique (JBT). Our previous single-arm study introduced a novel method to protect SB named double kissing inflation outside the stent (DKo), which features twice inflation of the protective balloon kissing with the stent balloon and post-dilation balloon.

Objective

To confirm whether DKo can protect SB better than JBT in a large sample of bifurcation lesions.

Methods

This retrospective, single-center cohort study enrolled 875 consecutive patients underwent bifurcation PCI either in DKo (n=209) or JBT group (n=666). The primary endpoint was transient SB loss after removal of the protective balloon. The secondary endpoints included rates of SB rewiring, final kissing balloon inflation (FKBI), SB stenting, final SB loss, and peri-procedural myocardial infarction (PMI).

Results

Transient SB loss occurred in only 1 patient (0.5%) in DKo but 32 patients (4.8%) in JBT (p<0.005). Transient loss in JBT group was triggered by rewiring (n=21), post-dilation (n=8) and severe dissection (n=3). DKo caused lower rates of rewiring (0.5% vs. 13.8%, p<0.001), FKBI (0.5% vs. 7.7%, p<0.001) and PMI (0.5% vs. 2.9%, p=0.045). SB stenting and final SB loss showed a lower tendency in DKo [0% vs. 0.8%, p=0.21; 0% vs. 1.2%, p=0.11]. DKo was the only protector against transient SB loss [odds ratio=0.08, 95% confidence interval (0.01-0.59), p=0.013].

Conclusion

DKo protects SB better than JBT in PCI for bifurcation lesions. Randomized controlled studies are required to confirm the long-term benefit.
Outcomes of drug eluting stents vs. drug eluting balloons. A single center experience
Authors: Kheifets M , Rahat O , Bental T , Levi A , Samara A , Greenberg G , Codner P , Witberg G , Vaknin-Assa H , Kornowski R , Perl L
Published: November 2023

Introduction

Drug eluting stents (DES) are considered the default treatment option in the current era of percutaneous coronary interventions (PCI). Nevertheless, the use of drug eluting balloons (DEB) remains highly relevant, especially in the setting of in stent restenosis (ISR), and de-novo small vessel disease or bifurcation lesions.

Material and method

Among 17,630 consecutive PCI procedures performed in our tertiary medical center between 2010 and 2021, we identified 16,435 procedures performed using DES and 1,195 using DEB. Endpoints included mortality and major adverse cardiac events [MACE: death, myocardial infarction (MI), target vessel revascularization (TVR), and coronary artery bypass surgery (CABG)] at 1 year. Propensity score matching was used to create a well-balanced cohort. Results and discussion: Mean age was similar (65.7±12.1 vs. 65.8±11.1, p=0.85), but less female patients (16.7% vs. 21.2%, p<0.01) were observed in the DEB group. DEB patients presented with higher rates of diabetes, hypertension, and prior CABG (62.1% vs. 48.1%, 84.9% vs. 73.2% and 18.3% vs. 10.1% respectively, p<0.01 for all), as compared to DES patients. There were also higher rates of PCI for bifurcation lesions and in-stent restenosis (18.3% vs. 15.1% and 56.0% vs. 7.8% respectively, p<0.01 for both) in the DEB group. After propensity and adjustment for confounders, 370 matched pairs were compared. 1-year MACE rates were significantly higher (HR-1.51, 95%CI 1.04-2.18, p=0.03) in the DEB group, as compared to the DES group. This was driven by higher MI (6.8% vs. 1.9%, p<0.01), TVR (20.5% vs. 11.4%, p<0.01) and CABG (12.2% vs. 7.3%, p=0.02) rates in the DEB group. Adjusted rates of 1-year mortality (HR-1.20, 95%CI 0.75-1.67, p=0.45) did not differ between the two groups.

Conclusions

Treatment with DEB was associated with increased MACE at 1-year, driven by higher rates of MI, TVR and CABG, as compared to DES.Freedom from MACE
Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: a systematic review and meta-analysis of 38 studies
Authors: Sagris M , Ktenopoulos N , Dimitriadis K , Papanikolaou A , Beneki E , Tzoumas A , Soulaidopoulos S , Lichtenberg M , Korosoglou G , Toutouzas K , Tousoulis D , Honton B , Tsiamis E , Tsioufis K
Published: November 2023

Introduction

Heavily calcified coronary lesions impede appropriate stent deployment and expansion, increasing the risk of complications. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe coronary calcification.

Purpose

Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in coronary before stenting.

Methods

This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL as well as stent implantation were analyzed. The occurrence of peri-procedural complications and major adverse cardiovascular events (MACE) in a 30-day period were assessed using a random-effects model.

Results

This meta-analysis comprised 38 studies including 2,977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL procedural success rate of 98% (95% CI: 96%-99%, I2=69.2%) and clinical success of 96% (95% CI: 93%-98%, I2=72.2%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI) and death were 8% (95% CI: 6%-11%, I2=84.5%), 5% (95% CI: 2%-8%, I2=85.6%) and 2% (95% CI: 1%-3%, I2=69.3%), respectively. There was a significant increase in the vessel diameter (SMD: 2.47, 95% CI: 1.77-3.17, I2=96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2=97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2=95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2=96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2=98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 mm and 1.94 ± 1.1 mm, respectively. Peri-procedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded.

Conclusions

The present meta-analysis shows that IVL constitutes an effective and safe technique for preparing severely calcified lesions before stent implantation in coronary arteries. These results support the use of IVL in the high procedural risk setting of severe coronary calcification.
Coronary rotational atherectomy in patients with severe aortic stenosis
Authors: Alotaibi S , Heyer H , Mankerious N , Landt M , Abdel-Wahab M , Geist V , Toelg R , Allali A , Richardt G , Elbasha K
Published: November 2023

Introduction

Rotational atherectomy (RA) has been shown to be safe and effective in patients with severe calcified coronary arteries lesions. However, clinical data on the use of RA in patients with concomitant severe aortic stenosis (AS patients) are lacking. Escalation to RA for coronary lesion preparation in patients undergoing transcatheter aortic valve implantation (TAVI) is still controversial, given their impaired haemodynamic status and possible higher risk of complications. We reported the clinical outcomes of AS patients undergoing RA and TAVI from a prospective clinical registry and compared their outcome with patients undergoing RA with no severe aortic valve stenosis (non-AS patients).

Methods

We retrieved data of all consecutively enrolled patients in a single centre registry from January 2016 up to October 2021. All AS patients who underwent RA prior to TAVI within a six-month period were included for our analysis. We compared the AS patients with all patients without severe aortic stenosis (non-AS patients) who underwent RA during the same period. Data were analysed to assess rates of in-hospital major adverse cardiovascular event (MACE) in AS vs non-AS patients. MACE was defined as composite of cardiac death, myocardial infarction, and target lesion revascularisation. Procedural characteristics as well as in-hospital outcomes and complications were also examined to detect differences between both patient groups. We then performed univariate and multivariate analyses using binary logistic regression with the presence of severe aortic stenosis as a dependent variable for MACE.

Results

A total of 472 patients underwent RA. Of those, 38 (8.05%) had severe AS and received TAVI within six months after index RA. Compared with the AS-patients, more non-AS patients presented with acute coronary syndrome (2.6% vs 19.8 %; p<0.009). Left main coronary artery intervention was documented in 36.8% of the AS-patients and in 25.1% of the non-AS patients. Mechanical circulatory support during the procedures was low (10 %) in both groups and was used only in two patients from the AS group. The procedural success was 97% and did not differ between both patients’ groups. There was no difference of in-hospital MACE between the AS and non-AS patients (7.9% vs 8.8%; p=0.418). Procedural rates of complications related to RA such as slow flow, coronary dissection, coronary perforation, or trapped burr did not differ between both patient groups. Adverse outcomes of RA were not affected by the presence of severe AS in the univariate analysis (OR 1.12; 95% CI [0.33-3.91]; p=0.857).

Conclusion

RA in patients with severe AS undergoing TAVI is feasible, and in-hospital adverse events were comparable to non-AS patients. Adequate lesion preparation of calcified coronary arteries should be implemented regardless of the presence of severe AS.
Observational, multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL): efficacy and safety outcomes
Authors: Pietrasik A , Gasecka A , Sacha J , Pawlowski T , Grygier M , Bielawski G , Sukiennik A , Witkowski A , Bartus S , Cacko A , Gil R , Kuliczkowski W , Wanczura P , Legutko J , Kochman J
Published: November 2023

Introduction

Impella (Abiomed, Danvers, MA, USA) is the smallest and the least invasive mechanical circulatory support device used in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCI). Data regarding the efficacy and safety of Impella in the real-life setting are urgently needed.

Purpose

The main goal of the IMPELLA-PL registry is to evaluate the efficacy and safety of Impella in patients with CS and undergoing HR-PCI, identify independent predictors of in-hospital and 12-month outcomes and compare it with other registries.

Methods

IMPELLA-PL is a national, multicentre, retrospective registry including consecutive patients treated with Impella for CS and high-risk PCI in 20 Polish interventional cardiological centres from January 2014 until December 2021, with 12-month follow-up until December 2022. The main efficacy and safety endpoints included (i) in-hospital mortality, (ii) 12-month mortality, (iii) 12-month rate of major adverse cardiovascular events (MACE) following hospital discharge, evaluated according to the prespecified definitions.

Results

A total of 308 patients were enrolled in the registry: 55 had CS (56.4%) and 253 underwent HR-PCI (43.6%). In the CS group, in-hospital mortality rate was 76.4%, 12-month mortality rate was 80.0% and post-discharge MACE rate was 9.1%. Device-related complications included access site bleeding (30.9%), limb ischaemia (12.7%) and haemolysis (10.9%). In the HR-PCI group, in-hospital mortality rate was 8.3%, 12-month mortality rate was 18.2% and MACE rate post-discharge was 22.5%. Device-related complications included access site bleeding (14.6%), limb ischaemia (2.4%) and haemolysis (1.6%). The independent predictors of 12-month mortality included atrial fibrillation (OR 3.50, 95% CI 1.38-8.95), chronic kidney disease (OR 2.77, 95% CI 1.06-7.26).

Conclusions

The mortality and complications rate in patients with CS remains high, despite the use of Impella, and higher than reported in other registries. The mortality and complications rate in patients undergoing HR-PCI is acceptable and consistent with other registries.
Impact of trial results and guidelines on the practice of Primary PCI over 14 years
Authors: Doerler J , Edlinger M , Alber H , Berger R , Binder R , Hasun M , Wintersteller W , Lassnig E , Huber K , Von Lewinski D , Rab A , Roithinger F X , Schuchlenz H , Steinwender C , Weidinger F
Published: November 2023

Aim

We aimed to present an overview of changes in daily practice of primary PCI in relation to on the growing evidence in device and adjunctive pharmacologic therapy.

Methods and results

Clinical outcomes, data on treatment as well as characteristics of 19,054 patients prospectively enrolled in a nation-wide registry of primary PCI between 2005 and 2018 were analysed. A year-by-year trend analysis was done to show the dynamic of changes following landmark trial publications and new guideline recommendations. Patient characteristics remained stable except a slight increase of patients needing resuscitation (from 8% to 12%) and treatment delays showed improvements over time. The prescription of new P2Y12 Inhibitors rapidly increased after approval in 2009. Femoral access was predominant in 2011 (over 90%) followed by a steady decrease to under 30% in 2018. The use of thrombus aspiration increased since 2008 with a maximum in 2013 followed by a decrease after publication of two negative randomised trials. Mortality was in average 6%.

Conclusion

Trial results and guideline recommendations had a strong impact on the practice of PPCI in this national registry. Despite improved treatments, the average in-hospital mortality of 6% indicates the necessity of continuous reassessment of treatment delays and other quality indicators to further improve patient outcome after STEMI.Changes over time
Efficacy of the tip-detection method over the retrograde approach for chronic total occlusion percutaneous coronary intervention
Authors: Kashiyama T , Okamura A , Koyama Y , Watanabe H , Iwakura K
Published: November 2023

Background

The tip-detection method has been acknowledged as a novel strategy for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) when conventional antegrade wiring strategies are ineffective, but a comparison with the retrograde approach has yet to be carried out.

Method

We retrospectively enrolled 170 consecutive CTO PCI cases and separated them according to the adopted strategies. The wire-manipulation time for each strategy was compared between the tip-detection method and the retrograde approach. The rate of successful wire crossing was analyzed according to the variables in the complexity scores.

Results

Fifty-six attempts with the tip-detection method were observed, with 46 (82.1%) successful cases. Sixty-one retrograde approaches were performed, in which 29 (47.5%) cases achieved procedural success. In the successful attempts, the wire-manipulation time was significantly shorter with the tip-detection method (20.0 [12.2-36.7] min) than with the retrograde approach (35.0 [20.7-49.7] min) (p=0.008). Incomplete tip-detection wire crossing (taking >30 min) was seen in severely tortuous lesions (odds ratio: 0.26, 95% confidence interval: 0.06–0.97, p = 0.037).

Conclusions

The tip-detection method can improve the rate and time required for successful CTO PCI compared with the retrograde approach. However, the success rate of the tip-detection method is hampered by lesion tortuosity.Figure
Characteristics and outcomes of elderly patients undergoing protected percutaneous coronary intervention with impella mechanical circulatory support
Authors: Jakob P , Falah B , Abu-Much A , Lansky A , Basir M B , Schonning M , Zhou Z , Batchelor W , Grines C , O'neill W , Stahli B A R B A R
Published: November 2023

Background/Introduction

In high-risk patients, percutaneous coronary intervention (PCI) with Impella mechanical circulatory support has become an important part of the revascularization strategy. However, data regarding the impact of age in patients undergoing Impella-supported PCI are limited.

Purpose

The aim of this study was to describe the characteristics and outcomes of Impella mechanical circulatory support in patients ≥75 years of age undergoing high-risk PCI.

Methods

Using the PROTECT III study, a prospective, multicenter, FDA-audited cohort of the Catheter-based Ventricular Assist Device (cVAD) registry, we compared baseline characteristics and clinical outcomes of patients ≥75 years of age with those of patients <75 years of age treated with Impella-supported high-risk PCI. Rates of major adverse cardiovascular and cerebral events (MACCE), defined as the composite of all-cause death, myocardial infarction (MI), stroke/transient ischemic attack, and revascularization, were assessed at 30 days and 90 days, and mortality was assessed to 1 year. A multivariable Cox regression model (including covariates significant in univariable analysis) was used to examine associations between age and clinical outcomes.

Results

A total of 1237 patients (26.8% female) were included in the analysis; of whom 493 (39.9%) were ≥75 years of age. Patients ≥75 years of age had lower body mass index (27 kg/m² vs. 30 kg/m²), a lower prevalence of diabetes (49% vs. 61%) and prior MI (37% vs. 43%), and lower estimated glomerular filtration rates (eGFR, 60 vs. 74 mL/min/1.73 m²). They more often suffered from severe valvular heart disease (17% vs. 7%), and more frequently underwent left main PCI (58% vs. 39%). Left ventricular ejection fraction was higher in patients ≥75 years of age (37.7±15.9% vs. 32.0±14.5%). (p<0.05 for all comparisons). Baseline SYNTAX scores did not differ among groups. Rates of death and MACCE did not differ between age groups at either 30 days or 90 days (Figure 1). Mortality at 1 year was 24.0% in patients ≥75 years of age and 17.9% in those <75 years of age. Age ≥75 years was associated with an increased risk of mortality at 1 year (unadjusted HR 1.40, 95% CI 1.05-1.86, p=0.02) and the association remained significant after multivariable adjustment (adjusted HR 1.99, 95% CI 1.24-3.18, p=0.004; Figure 2).

Conclusion(s)

This study demonstrates that increased age ≥75 years was not associated with a higher risk of mortality or MACCE at 30 or 90 days following protected PCI with Impella mechanical circulatory support, suggesting that protected high-risk PCI in elderly patients is safe and feasible. However, age ≥75 years remained an independent predictor for 1-year mortality after protected PCI.30-day and 90-day MACCE1-year All-cause death
Evidence of early bioprosthetic valve dysfunction after TAVR in aortic valve stenosis during one-year follow-up according to VARC-3
Authors: Heermann J , Hokken T W , Hecht S , Goh S , Maier O , Adrichem R , Nuis R J , Abdel-Wahab N , Van Mieghem N M , Kelm M , Zeus T , Veulemans V
Published: November 2023

Objectives

Transcatheter aortic valve replacement (TAVR) has become a frequent treatment method for severe aortic stenosis and has increased significantly in younger patients and at lower surgical risk. Therefore, long-time considerations and the performance of TAVR devices are highly interesting. The Valve Academic Research Consortium 3 endpoint definitions (VARC-3) were released recently, offering updated and clear classifications of bioprosthetic valve dysfunction (BVD). In this retrospective multicenter study, we aimed to assess the prevalence of BVD during one-year follow-up and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV).

Methods

Underlying conditions were evaluated by univariate analysis. Normality was tested using the Shapiro-Wilk normality test. The primary clinical endpoint was defined as immediate failure in device success, secondary endpoints were defined as prevalence of BVD during one year FU and composite endpoints according to VARC-3.

Results

The final study cohort consisted of 1478 patients from three tertiary care centers that underwent TAVR between 01/2015 and 12/2018. Mean Follow-up (FU) was 361 ± 26 days. During this time span overall BVD was documented in one-fourth of all patients (-BVD[-]: n=1090 (73.7%); BVD[+]: n=388; 26.3%). Further discrimination into the four main categories of BVD presented following results: Structural valve deterioration (SVD) n=142 (9.6%), Non-Structural valve deterioration (NSVD) n=235 (15.9%), hypo-attenuated leaflet thickening n=18 (1.2 %), and endocarditis n=31 (2.1%). Two-thirds of all events were identified within 30-days post implantation, accounting for new-onset of BVD during time course in one-third of all documented BVD. Device success was significantly lower in the +BVD cohort (80.6% vs. 70.1%, p<0.01*). When comparing SEV and BEV, there were significant differences in overall BVD at 30-days post implantation (13.8% vs 18.5%, p<0.01*), as well as in device success (74.1% vs. 81.5%, p<0.01*), early safety (63.8% vs. 69.8%, p=0.014) and clinical efficacy (94.1% vs. 89.9%, p<0.01*). Again, discrimination into the four main categories of BVD showed differences in NSVD at 30-days post implantation (9.8% vs. 14.3%, p<0.01*) as well as at 1-year FU (7.6% vs 14.8%, p<0.01*).

Conclusion

In this large retrospective multicenter study, we could observe that NSVD was the BVD category most frequently detected after TAVR in tricuspid aortic valves during 1-year FU. NSVD occurred mainly within 30 days post-implantation in patients with balloon-expandable valves, being one factor that significantly diminished device success, early safety, and clinical efficacy.
End of life after transcatheter aortic valve implantation
Authors: Strange J E , Holt A , Christensen D M , Nouhravesh N , Petersen J K , Schou M , Backer O D , Koeber L , Fosbol E L
Published: November 2023

Background

Survival after transcatheter aortic valve implantation (TAVI) has drastically improved over time. Thus, patients may be more susceptible to experience multimorbidity and non-cardiovascular hospitalizations in their final years of life; however, the extent of which comorbidities impact end of life after TAVI is unknown.

Purpose

To describe end of life after TAVI in terms of the burden and causes of hospitalization compared with non-TAVI controls from the general population.

Methods

All Danish patients who underwent TAVI during 2008–2021 were identified at date of death. Patients who died within one year from TAVI were excluded. Matching was performed on sex, age at death, and calendar year of death in a 1:10 ratio. Patient characteristics at time of death were reported. Cumulative time in hospital was calculated and compared for the TAVI group and matched controls. Further, the cause for all inpatient hospitalizations were categorized as heart failure, cardiovascular (excluding heart failure), non-cardiovascular, and symptoms (e.g., dyspnea, vomiting) according to the primary discharge code.

Results

After exclusion, 2,041 deaths among patients with TAVI (median time from TAVI to death: 1,352 days [25th-75th percentile: 841–1,980]) were matched to 20,410 deaths among controls (standardized mean differences < 0.1 for all matching variables). Due to matching, age was 86 years, and 54.7% were males in both groups. However, frailty was higher in the TAVI group (frail TAVI group: 86.5% vs. controls: 76%). Cardiovascular and non-cardiovascular comorbidity burden was higher in the TAVI group (e.g., heart failure: 57.6% vs. 18.4%; chronic obstructive pulmonary disease: 27.9% vs. 18.8%; chronic kidney disease: 25.7% vs. 12.9%). However, history of cancer was lower in the TAVI group (21.7% vs. 26.3%).

Time in hospital in the last year of life was higher in the TAVI group: 27.2% were hospitalized >28 days and 11.5% were never hospitalized compared with 17.1% and 22.7% for controls, respectively (Figure 1). In both groups, non-cardiovascular hospitalizations were most common towards end of life. Indeed, 70.5% of hospitalizations during the last year of life for TAVI patients were due to non-cardiovascular causes. Moreover, in both groups, non-cardiovascular hospitalizations became more frequent closer to time of death (Figure 2). However, heart failure hospitalizations were more common in the TAVI group compared with controls.

Conclusion

End of life for TAVI patients was characterized by substantial multimorbidity and hospitalizations are frequent. Although heart failure hospitalizations were more common for TAVI patients than their matched controls, non-cardiovascular hospitalizations were more frequent in both groups. This highlights the need for a multidisciplinary approach to improve quality of life towards end of life after TAVI.Figure 1
High-risk admission prior to transcatheter aortic valve implantation and subsequent outcomes
Authors: Strange J E , Schou M , Nouhravesh N , Christensen D M , Holt A , Oestergaard L , Koeber L , Olesen J B , Fosbol E L
Published: November 2023

Background

Severe symptomatic aortic stenosis may cause heart failure, acute myocardial infarction, or syncope; however, limited data exist on the occurrence of such events before transcatheter aortic valve implantation (TAVI) and their impact on subsequent outcomes.

Purpose

To investigate the association between a preceding event (hospitalization for heart failure, acute myocardial infarction, or syncope) and outcomes after TAVI.

Methods

Using nationwide registries, all Danish patients undergoing TAVI from 2014 through 2021 were identified. Preceding events up to 180 days before TAVI were identified. Patients were then stratified into two groups: 1) patients with a preceding event. 2) patients without a preceding event.

The primary outcome of interest was 1-year risk of all-cause death estimated with Kaplan-Meier for patients with a preceding event compared with patients without. The secondary outcome of interest was 1-year cardiovascular rehospitalization amongst patients discharged alive. Here, we used Aalen-Johansen with the competing risk of death among patients alive at discharge. Finally, adjusted analyses were performed with Cox regression analyses.

Results

The main findings are summarized in Figure 1. The study population comprised 5,851 patients. Of these, 759 (13.0%) had a preceding event. Median age was 81 years in both groups. Frailty and male sex were more prevalent among patients with a preceding event (males: 64.7%, intermediate/high frailty: 49.6%) compared with patients without a preceding event (males: 55.2%, intermediate/high frailty 40.6%). A hospitalization for heart failure was the most common preceding event (n=524).

The risk of 1-year all-cause death was 11.7% (95% CI: 9.4%–14.1%) for patients with a preceding event compared with 8.0% (95%CI: 7.2%–8-7%) for patients without a preceding event (Figure 2). This resulted in an adjusted hazard ratio of 1.29 (95%CI: 1.01–1.64). Moreover, the 1-year risk of cardiovascular rehospitalization was 15.0% (95 CI: 12.4%–17.6%) versus 8.2% (95 CI: 7.4%–8.9%) for patients with and without a preceding event (adjusted hazard ratio 1.60 [95%CI: 1.29–1.99]) (Figure 2).

Conclusion

A hospitalization for heart failure, acute myocardial infarction, or syncope prior to TAVI is associated with a higher risk of mortality and cardiovascular rehospitalization. These patients should be carefully evaluated prior to and after TAVI to improve outcomes.
Impact of right ventricular to pulmonary artery coupling on remodeling and outcome in patients undergoing transcatheter edge-to-edge mitral valve repair
Authors: Koschutnik M , Dona C , Nitsche C , Kammerlander A , Dannenberg V , Koschatko S , Mascherbauer K , Heitzinger G , Halavina K , Winter M P , Huelsmann M , Bartko P , Hengstenberg C , Mascherbauer J , Goliasch G
Published: November 2023

Background

Right ventricular to pulmonary artery (RV-PA) coupling has recently been shown to be associated with outcome in valvular heart disease. However, longitudinal data on RV dysfunction and reverse cardiac remodeling in patients following transcatheter edge-to-edge mitral valve repair (M-TEER) are scarce.

Methods

Consecutive patients with primary as well as secondary mitral regurgitation (MR) were prospectively enrolled and had comprehensive echocardiographic and invasive hemodynamic assessment at baseline. Kaplan-Meier estimates and multivariable Cox-regression analyses were performed using a composite endpoint of heart failure hospitalization and death.

Results

Between April 2018 to January 2021, 156 patients (median 78 y/o, 55% female, EuroSCORE II: 6.9%) underwent M-TEER. On presentation, 64% showed impaired RV-PA coupling defined as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio <0.36. Event-free survival rates at 2 years were significantly lower among patients with impaired coupling (57 vs. 82%, p<0.01), both in patients with primary (64 vs. 91%, p=0.01) and secondary MR (54 vs. 76%, p=0.03). On multivariable Cox-regression analyses adjusted for baseline, imaging, hemodynamic, and procedural data, TAPSE/PASP ratio <0.36 was independently associated with outcome (adj.HR 2.74, 95%CI: 1.17-6.43, p=0.02).

At 1-year follow-up, RV-PA coupling improved (TAPSE: ∆ +3mm, PASP: ∆ -10mmHg, p for both <0.01), alongside with a reduction in tricuspid regurgitation (TR) severity (grade ≥II: 77 to 54%, p<0.01).

Conclusion

TAPSE/PASP ratio was associated with outcome in patients undergoing M-TEER for primary as well as secondary MR. RV-PA coupling, alongside with TR severity, improved after M-TEER and might thus provide prognostic information in addition to established markers of poor outcome.Graphical Abstract
Head-to-head comparison of two embolic protection devices in carotid artery stenting
Authors: Silva A , Santos T , Simoes M , Batista G , Martins J , Costa M , Goncalves L
Published: November 2023

Introduction

Embolic protection devices (EPD) have been developed to reduce the risk of distal embolization and have become ubiquitous in carotid interventions. There are two classes of EPD: distal filter EPD (f-EPD) and proximal EPD (p-EPD). However, the best device for carotid artery stenting (CAS) has yet to be established.

Purpose

We aimed to assess and compare the early prognosis between the f-EPD and p-EPD groups in patients undergoing CAS.

Methods

Single-center, retrospective study. Patients who underwent CAS from 2000 to 2022 were included. The composite of transient ischemic attack(TIA)/stroke and death at 24 hours and 30 days were evaluated. Statistical analysis was performed using SPSS 28.0.1.1 software.

Results

A total of 436 patients were included (380 and 56 patients used f-EPD and p-EPD, respectively). The population's mean age (±SD) was 71,8 (±8,2) years, 74,8% men. There was a significant prevalence of arterial hypertension (88,3%), dyslipidemia (75,9%), diabetes (33,9%), and smoking background (25,9%). Regarding baseline clinical characteristics, arterial hypertension was more prevalent in the f-EPD group, with statistical significance (91,7% vs. 78,8%; p=0,003).

Concerning the indications for carotid intervention, 16,1% of patients were asymptomatic but had severe stenosis, and 39,4% had neurological symptoms. In 41,9% of patients, the procedure was accomplished before cardiac surgery (coronary artery bypass graft or valvular surgery).

Regarding the first 24 hours after the procedure, the combined endpoint of TIA/stroke or death occurred in 3,4% of patients in the f-EPD group and 3,6% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was also similar in both groups (3,2% and 3,6% in the f-EPD and p-EPD groups, respectively; no statistical difference was found; p=0,694). The early mortality rate was slightly lower in the f-EPD group (0,8%) compared with the p-EPD group (1,8%), though this difference did not reach statistical significance (p=0,424).

During the 30-day follow-up, the combined endpoint of TIA/stroke or death occurred in 1,6% of patients in the f-EPD group and 1,8% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was lower in the f-EPD group (1,1%) compared to the p-EPD group (1,8%), however, no statistical difference was found (p=0,499). Regarding mortality rate, the incidence in the f-EPD group was 0,5%, in contrast with no events in the p-EPD group (statistical analysis not possible to compute).

Conclusion

In this cohort, no significant differences were found between the distal filter and proximal embolic protection devices in the risk of TIA/stroke and death at 24 hours and 30 days after carotid artery stenting. However, conclusions should be carefully drawn since the distal filter EPD was used more often than the proximal EPD, making direct comparisons challenging.
Healthy vascular ageing protects community dwelling elderly from all-cause mortality: 5-year evidence from the North Shanghai Study
Authors: Ren Z , Jia R N , Zhang Y , Xu Y W
Published: November 2023

Background

Healthy vascular ageing (HVA) defined by normal pulse wave velocity (PWV) has been recognized as a valuable indicator of vascular status. And HVA strongly correlates with preclinical targeted organ damage (TOD). While the long-term benefit of HVA remains to be investigated.

Aims

To investigate the long-term outcome of population with HVA based on large registered North Shanghai Study.

Methods

Since Jun. 2014, 3363 community-dwelling elderly Chinese (age ≥65 years) were enrolled in the Northern Shanghai Study. HVA was defined as normal carotid femoral PWV that stratified by age and blood pressure. TOD was measured and categorized as vascular TOD indicated by carotid-femoral PWV and ankle-brachial index, cardiac TOD indicated by left ventricular hypertrophy and diastolic dysfunction, and renal TOD indicated by estimated glomerular filtration rate and urinary albumin/creatinine ratio. Follow-up outcome including all-cause mortality, cardiovascular and non-cardiovascular mortalities were evaluated.

Results

1016 participants (30.2%) with HVA were identified. Compared with non-HVA group, although no gender difference, HVA group had younger age, lower blood pressure, lower body mass index (BMI), and milder TODs. Through a follow-up period of 5.7±1.8 years, 233 (6.9%) all-cause deaths, including 94 (2.8%) cardiovascular deaths were observed. Participants with HVA showed significantly higher survival from all-cause deaths (Log-rank P=0.002) and cardiovascular deaths (Log-rank P=0.003), but statistically non-significant survival from non-cardiovascular deaths (Log-rank P=0.098).Subgroup analysis showed that HVA was a significant protective factor in female (HR 0.412 (0.245, 0.692), P=0.002), participants aged 65-70 (HR 0.417 (0.194, 0.897), P=0.025), participants with BMI<25 (0.570 (0.386, 0.842) P=0.005), and participants with at least 1 TOD (HR 0.634 (0.444, 0.907), P=0.013). Moreover, the protective value of HVA was only significant in participants without cardiac TOD (0.681, (0.464, 0.998), P=0.049), participants with renal TOD (0.547, (0.354, 0.844), P=0.006), and participants with vascular TOD (0.461 (0.251, 0.848), P=0.013).

Conclusion

In community-dwelling elderly, HVA could be a significant protective factor for all-cause deaths, especially in subpopulation of female, age 65-70, BMI<25 and with renal and/or vascular TOD.
Effect of hypertensive response to exercise on aortic diameters
Authors: Van Der Stouwe J G , Schmied C M , Niederseer D
Published: November 2023

Background

The diameters of the sinus of Valsalva as well as the ascending aorta are related to age, sex, and body size. There are conflicting data regarding the effect of arterial hypertension and a scarcity of data on the effect of a hypertensive response to exercise on aortic diameters.

Purpose

In this prospective cohort study, we aimed to evaluate the relationship between the growth rates of the sinus of Valsalva and ascending aorta in individuals with a hypertensive response to exercise.

Methods

Our analysis included follow-up data of 649 patients from our cohort study. Participants with known connective tissue disease were excluded. Sinus of Valsalva and ascending aorta diameters were measured by transthoracic echocardiography using leading edge to leading edge convention at end-diastole. Maximum systolic and diastolic blood pressure response to exercise was measured during a standardized exercise test.

Results

At baseline, median age, max. systolic BP, BMI, diameter of the sinus of Valsalva, and diameter of the ascending aorta were 62 years, 208 mmHg, 26.9 kg/m2, 35mm, and 35mm respectively. 32% of patients were female and 67% had known arterial hypertension. After a median follow-up of 7.1 years, mean growth rate of the sinus of Valsalva and ascending aorta were 0.09 mm and 0.13 mm per year respectively. In univariate and multivariable regression models, there was a small but significant association between baseline aortic diameters and max. systolic BP, as shown in the Table 1. No significant associations were observed between growth rate of aortic diameters and max. systolic BP, as shown in the Table 2. Similar findings were obtained for max. diastolic BP and when considering only individuals with a baseline diameter ≥ 40mm.

Conclusion

In this large prospective cohort study, there was a small inverse relationship between max. systolic BP during exercise and baseline aortic diameters. However, max. systolic BP during exercise showed no influence on growth rates of aortic diameters. Furthermore, the mean growth rates of aortic diameters per year in this population were in line with growth rates in a normal population.Table 1.Table 2
Ten year follow-up study regarding treatment compliance and cardiovascular events in young first diagnosed and never treated hypertensives of a European Society of Hypertension Excellence Center
Authors: Triantafyllidi H , Benas D , Sioula K , Fambri A , Birmpa D , Ikonomidis I
Published: November 2023

Background

Early onset arterial hypertension (AH) is associated with a considerably increased risk for cardiovascular (CV) disease if left untreated. Treatment is based on the estimation of CV risk in each hypertensive patient. The compliance of each individual hypertensive in proposed life style changes and medical treatment is paramount. We aimed to investigate the compliance in medical treatment and we set as primary endpoint of the study the incidence of any CV events [CV death, acute myocardial infarction (AMI), stroke] and all-cause death of a cohort of young first diagnosed and never treated hypertensives of a European Society of Hypertension (ESH) Excellence Center.

Population and Methods: We studied 220 young, non-diabetic (<50 years old) first diagnosed and never treated hypertensive patients (42+7 years, 70% males, 41% smokers, BMI=29+5, 24-h ambulatory blood pressure monitoring (ABPM) =142+10/91+9 mmHg, LDL=133+36 mg/dl, 49% had >1 HMOD) visiting our ESH Excellence Center (2004-2021). All patients were apparently healthy with no co-morbidities. In each patient, the presence of hypertension mediated organ damage (HMOD) was evaluated at baseline (aortic stiffness, left ventricular hypertrophy, coronary flow reserve, diastolic dysfunction. The cohort was re-evaluated at 10+4 years post-medical treatment initiation regarding compliance as well as the primary endpoint of the study.

Results

191/220 (87%) young hypertensives (at baseline, 42+7 years, 70% males, 40% smokers, BMI=29.5, 24-h ABPM=142+10/91+9 mmHg, LDL=133+36 mg/dl, 49% had>1 HMOD) participated in the follow-up study while 29 (13%) patients were lost. We found that 17/191 (9%) quit medical treatment. Home or office BP was confirmed as controlled (<140/90 mmHg) in 151/191 (79%) patients. Regarding CV events, 7/191 (4%) hypertensive patients (at baseline, 44+4 years, 86% males, 71% smokers, BMI= 30+4, 24-h ABPM=142+12/89+10 mmHg, LDL=175+33 mg/dl, 87% had>1 HMOD) had an acute myocardial infarction (AMI) at 6+4 years post-treatment initiation while 1/191 (0.5%) patient died due to lung cancer. Hypertensive patients with CV events differed regarding increased LDL levels at baseline (168+35 vs.131+36, p=0.007), more smokers (p=0.04) and HMOD >1 (p=0.02) compared to the rest of the young hypertensive population.

Conclusions

Compliance regarding medical treatment was sustained in 9/10 young hypertensive patients during the 10-year follow-up. Just 4% of the population, smokers with increased LDL and HMOD>1, suffered an AMI despite compliance in medical antihypertensive treatment. Subsequently, treating AH in young people needs both life style changes (quit smoking) and medical treatment (hypertension plus hyperlipidemia) in order to prevent future CV events.CV events in young hypertensives