bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of myocardial bridge defined by computed tomographic coronary angiography on fractional flow reserve after elective percutaneous coronary intervention
Authors: Sakamoto T , Usui E , Hoshino M , Hada M , Hanyu Y , Nagamine T , Ueno H , Nogami K , Matsuda K , Yonetsu T , Sasano T , Kakuta T
Published: November 2023

Background

Myocardial bridge (MB) is a common anomaly of epicardial coronary artery that courses through myocardium. MB can be identified by computed tomographic coronary angiography (CTCA) or invasive coronary angiography (ICA). However, its relevance to coronary physiological parameters remains unknown.

Purpose

This observational study aimed to explore how MBs affect physiological parameters in patients with chronic coronary syndrome before and after revascularization.

Methods

We investigated 172 consecutive patients who underwent preprocedural CTCA and elective fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) in left anterior descending artery (LAD). We compared patient characteristics, angiographic, and pre- and post-PCI physiological parameters in patients with versus without MB.

Results

We identified MB in 70 (40.7%) and 23 (13.3%) patients by CTCA and ICA, respectively. CTCA detected the presence of MB with a sensitivity of 100% and a specificity of 33% when ICA-defined MB was regarded as a reference standard. Longer MB (adjusted odds ratio 1.18 [95% confidence interval 1.05-1.33], P < 0.01) and smaller left ventricular myocardial mass volume in whole LAD territory (adjusted odds ratio 0.93 [95% confidence interval 0.89-0.98], P<0.01) were associated with ICA detectability of MB. Older age and higher frequency of diabetes mellitus were observed in patients with MB compared with those without MB. Pre-PCI FFR values were not associated with a presence of MB regardless of either CTCA- or ICA-defined MB. On the other hand, post-PCI FFR values were significantly lower in patients with versus without MB by CTCA (0.82 [0.80-0.86] vs. 0.86 [0.82-0.89], P<0.01), while no significant difference was observed in post-PCI FFR between patients with and without ICA-defined MB (0.82 [0.81-0.84 vs. 0.84 [0.80-0.88], P=0.08). Multivariable linear regression analysis revealed that a presence of CTCA-defined long MB (≥25mm) (adjusted β coefficient = -0.040, P<0.01) and greater myocardial mass volume in whole LAD territory (adjusted β coefficient = -0.0004, P<0.01) were independently associated with lower post-PCI FFR.

Conclusion

A presence of MB was an independent predictor of lower post-PCI FFR after successful and elective PCI for LAD.
Bivalirudin versus Heparin in ST and non-ST-segment elevation myocardial infarction
Authors: Omerovic E
Published: November 2023

Background

The registry-based randomized VALIDATE-SWEDEHEART trial compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days.

Methods

Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report here the study results for the extended follow-up time.

Results

In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70% of all eligible patients with these diagnoses during the course of the study. The primary endpoint occurred in 14.0% (421 of 3004) in the bivalirudin group compared with 14.3% (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95% confidence interval [CI], 0.85 – 1.11; P=0.70) at one year and in 16.7% (503 of 3004) compared with 17.1% (514 of 3002), (HR 0.97; 95% CI, 0.96 – 1.10; P=0.66) at two years (Figure 1). The primary outcome at two years was consistent across all prespecified subgroups, including risk groups with high age, gender, chronic renal failure, diabetes mellitus, and smokers (Figure 2).

Conclusions

Till two-years follow-up there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.Figure 1Figure 2
Very long-term prognostic value of clinical SYNTAX score in patients undergoing percutaneous coronary intervention for left main coronary artery disease
Authors: Lee J , Jung M , Kwak H , Chang E , Jung J , Rhee E , Park Y , Park B , Kim H , Kim N , Jang S , Bae M , Yang D , Park H , Cho Y
Published: November 2023

Background

Recently, long-term prognostic value of SYNTAX score (SS) has been validated in patients with left main coronary artery disease (LMCA). However, the ability of clinical SYNTAX score (CSS) to predict very long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for LMCA has not been fully investigated yet.

Purpose

We aimed to validate the impact of CSS on very long-term outcomes in patients undergoing PCI for LMCA.

Methods

Between June 2006 and December 2012, 279 patients underwent unprotected LMCA PCI were analyzed. The SS for each patient was calculated by scoring all coronary lesions using SS algorithm. CSS was calculated by multiplying the SS to an ACEF score (age/left ventricular ejection fraction + 1 if serum creatinine>2mg/dL). Major adverse cardiac events (MACEs) were defined as death, non-fatal myocardial infarction, and revascularizations. Mean follow-up duration was 2,529±1664 days.

Results

The CSS (26.8±11.9 versus 39.9±26.1, p<0.001) as well as SS (23.2±6.9 versus 25.8±7.9, p=0.003) was significantly higher in patients with MACEs. Area under the curve for MACEs (0.672 versus 0.599, p=0.0023) and mortality (0.744 versus 0.626, p<0.0001) of CSS was significantly higher compared with those of SS (Figure 1). The CSS significantly improved the reclassification and the integrated discrimination of patients compared to SS. Log CSS was an independent predictor for MACEs (hazard ratio [HR] 5.37, 95% confidence interval [CI] 1.98 – 14.61; p = 0.006) and mortality (HR 11.69, 95% CI 3.30 – 41.31; p < 0.001). When patients were categorized into 3 groups according to tertiles of CSS (Low CSS ≤ 22, 22 < Mid CSS ≤ 34, High CSS > 34), patients in the highest CSS tertile had significantly higher rates of MACEs (log-rank p<0.001) and mortality (log-rank p<0.001) compared with those in the lower 2 tertiles (Figure 2). The highest CSS tertile was an independent predictor for MACEs (HR 2.33, 95% CI 1.42 – 3.82; p = 0.001) and mortality (HR 5.66, 95% CI 2.20 – 14.57; p < 0.001).

Conclusions

The CSS is useful to predict very long-term clinical outcome in patients underwent unprotected LMCA PCI.
Feasibility and efficacy of a novel 6 french sheathless guiding catheter equipped with peel-off type external dilator for PCI with distal radial approach - a Japanese multicenter study
Authors: Yamada T , Izumikawa T , Taniguchi N , Hata T , Nakajima S , Takahashi A
Published: November 2023

Introduction

Recently, distal radial access has emerged as a promising alternative access to minimize access site complications.

Objectives

The aim of this study was to evaluate feasibility and efficacy of a novel 6-Fr sheathless guiding catheter system equipped with peel off type outer dilator for the patients who underwent percutaneous coronary intervention through distal radial artery.

Methods

Between Oct 2018 and January 2023, a total of 168 patients including 27 patients with ST elevation myocardial infarction underwent percutaneous coronary intervention using a 6-Fr novel sheathless guiding catheter in 2 Japanese hospitals with distal radial approach. The guiding catheter system include a 6-Fr guiding catheter and an inner and outer (peel-off type)dilater to prevent potential vascular damage during passage of the tip of the catheter. After puncture of the distal radial artery with 22 gause needle, a 0.025 inch guidewire with 220 cm length was inserted. Then, a seathless guiding catheter system equipped with both inner and outer sheath was advanced through skin surface for dilatation of puncture point. After peeling off the outer sheath, the catheter with inner sheath was advanced. Hemostatic method complies compression with a hemostatic pad and elastic bandage for 3 hours. Procedural success, bleeding complication and radial occlusion examined using Doppler ultrasound at discharge was accessed.

Results

Mean age of the patients was 72.1 ± 11.3 years old and 114 patients were male. Procedural success was 100 % with no patient requiring conversion to conventional radial access. The culprit lesion was located in the right coronary artery in 45 patients, the left anterior descending artery in 86 patients, the left circumflex artery in 21 patients, and the left main trunk in 12 patients. Doppler ultrasound examination of the distal radial artery at 1-day follow-up was available in all patients, with 2 patients (1.2%) was found to have radial artery occlusion. One patient (0.6%) presented forearm hematoma equivalent to EASY hematoma classification I and 4 patients (2.4%) showed dorsum hematoma.

Conclusions

The current study demonstrated that the use of a novel sheathless guiding catheter with outer dilator for distal radial approach in PCI was feasible and may contribute further reduction of procedure-related complications.peel-off type outer dilaterinsertion procedure
The effect of heparin dose on radial artery occlusion in patients undergoing coronary procedures via distal radial access: a sub-analysis of a randomized trial
Authors: Tsigkas G , Apostolos A , Papageorgiou A , Moulias A , Vasilagkos G , Papanikolaou A , Katechis S , Koufou E , Koros R , Trigka A , Travlos C , Chamakioti M , Bozika M , Nastouli K M , Davlouros P
Published: November 2023

Background

Radial artery occlusion (RAO) is the most common complication following coronary catheterization. Several measures have been taken to prevent RAO, including increasing the dose of unfractionated heparin (UFH) and using a distal radial artery (DRA) approach. However, the effect of a higher dose of UFH on RAO incidence in the DRA approach remains unclear.

Purpose

This study aims to investigate the impact of heparin dose (50IU/kg or ≥70IU/kg) after DRA approach on RAO incidence.

Methods

Data were obtained from a previous randomized controlled trial comparing distal to conventional radial access regarding RAO. Patients having undergone DRA access were stratified into two groups based on heparin dose received. A Pearson chi-square test was used to compare RAO incidence between the groups, and a multivariate logistic regression analysis was performed, considering baseline and periprocedural details.

Results

Data on RAO incidence and heparin dose were available for 768 patients, and 379 catheterized via DRA. A total of 234 patients received ≥70IU/kg heparin dose and the rest 145 received 50IU/kg. A higher dose of UFH was not associated with a lower incidence of RAO (3.3% vs. 3.4%, p=0.957). Multivariate logistic regression analysis showed that the use of 5-Fr sheaths (odds ratio [OR]: 0.044, 95% CI: 0.003-0.755), a lower number of diagnostic catheters (OR: 2.47, 95% CI: 1.250-4.878), and a shorter total procedure time (OR: 1.034, 95% CI: 1.011-1.059) were significantly associated with lower rates of RAO.

Conclusions

Our analysis indicates that a higher dose of UFH (≥70IU/kg) did not reduce RAO incidence in DRA access. Further studies with larger sample sizes are necessary to confirm these findings.
Right and left radial access for coronary angiography and percutaneous coronary intervention after coronary artery bypass graft surgery: no need to go down
Authors: Cutz M , Pina Y , Castillo G
Published: November 2023

Introduction

Currently is estimated that at least 90% of the coronary studies are performed through the radial access. However, in patients with prior coronary artery bypass graft surgery (CABG) the femoral access continues to be widely used due to an easier and more successful graft engagement. Evidence of the efficacy and security of the radial approach use in this population is both scarce and controversial.

Purpose

We aimed to compare radial (right and left) versus femoral access to perform coronary angiography (CA) and/or percutaneous coronary intervention (PCI) after CABG.

Methods

In this comparative historical cohort study conducted at a national reference center, all CA and PCI performed from January 2012 to October 2022 were eligible for review. Electronic and physical records were examined for demographic and interventional data. Groups were classified for comparison as CA plus PCI, CA only and PCI only.

Results

We identified 563 patients; radial access was used in 227 (40%). In CA plus PCI group, in only one case existed failure to cannulate bypass grafts by the initial chosen access (from right radial access [RRA] to the left internal mammary artery [LIMA]). The crossover rate for any cause other than graft cannulation failure was 11.3% with right radial access (p = 0.002), 4.2% with left radial access (p = 0.28) and 0% with the femoral route. Fluoroscopy time was greater in RRA compared to femoral, nevertheless left radial access (LRA) had lower fluoroscopy time and contrast volume compared to RRA and femoral access. In the CA only group, failure to cannulate bypass grafts occurred exclusively when the LIMA had to be cannulated from the RRA (8.3% p=0.001); with a crossover rate for any cause other than graft cannulation failure was greater in the radial access compared to femoral (RRA 18.1% p < 0.001; LRA 4.2% p = 0.002; femoral 0.5% P=0.001), LRA had greater fluoroscopy time but the femoral access had greater contrast volume use in relation with a higher number of venous bypass grafts [143.64 mL (±69.36), p = 0.01]. There were 15 cases of PCI only, were fluoroscopy time and contrast volume were greater in LRA (N= 2 none were for treatment of LIMA) and lower in RRA compared to LRA and femoral access. Vascular complications were infrequent in all groups, being minor bleeding in the femoral access the most frequent, with no statistical significance.

Conclusion

Right and left radial access are feasible to perform coronary angiography and PCI after CABG, compared to the femoral route are associated with less contrast volume despite a greater crossover rate. This analysis suggests that the LRA should be preferred over the RRA when angiography of the LIMA is needed.
Ultrasound guided trans-radial access in the cardiac catheterisation laboratory: a systematic review and meta-analysis
Authors: Hamilton G W , Sharma V , Yeoh J , Yudi M , Raman J , Clark D J , Farouque O
Published: November 2023

Background

Although ultrasound (US) guidance for vascular access is now widely considered standard of care (1,2), its use for trans-radial access (TRA) in the cardiac catheterization laboratory is uncommon. There is a perception that US guidance offers no clinically relevant benefit over traditional palpation guided TRA, and this notion has been amplified by the inconsistent findings of individual studies.

Purpose

To evaluate the utility of US guidance for TRA when performed specifically for cardiac catheterisation.

Methods

A systematic review of MEDLINE, EMBASE and the Cochrane Library identified studies comparing US to palpation guided TRA for cardiac catheterization. Event rates and calculated risk ratios (RR) were pooled for meta-analysis. Access failure was the primary outcome, defined as an inability to insert a sheath into the radial artery with the initial access strategy (US or palpation guided). Random effects modelling was used for analysis.

Results

Of the 977 studies screened, 5 were included with a total of 1,918 patients (961 US-guided and 964 palpation-guided, Table 1). The majority of procedures were elective. US guidance significantly lowered the risk of access failure (risk ratio [RR] 0.45, 95% confidence interval [CI] 0.21 – 0.97), with moderate heterogeneity (I^2 = 51.2%) (Figure 1). There was a strong trend to improved first pass success with US (RR 1.29, 95% CI 1.00 – 1.66, I^2 = 83.8%), though no differences were found in rates of difficult access (RR 0.29, 95% CI 0.07 - 1.18, I^2 = 88.3%). Salvage US guidance was successful in 30/41 (73.2%) patients following failed palpation guided TRA. No differences were found in already low complication rates including radial artery spasm (RR 0.92, 95% CI 0.52 – 1.62, I^2 = 34.8%) and bleeding (RR 0.92, 95% CI 0.40 – 2.11, I^2 = 0.0%). No studies evaluated patient-reported outcome measures.

Conclusions

US guidance improves TRA success in the cardiac catheterisation laboratory. Further investigation is necessary to determine whether routine, selective, or salvage use of US confers the most radial artery protection, patient satisfaction, and overall clinical benefit. Future studies should have standardised outcome measures including femoral crossover rates and patient reported outcome measures
Predictive role of intracoronary electrocardiography for procedural success in patients with ST-elevation myocardial infarction developing coronary no-reflow
Authors: Ozkaya Ibis A N , Sunman H , Kalkan K , Tunca C , Tas A , Ozkan M T , Erol N I , Tulmac M
Published: November 2023

Background

The no-reflow phenomenon (NRP) is associated with increased mortality and development of heart failure in patients with ST-segment elevation myocardial infarction (STEMI). Although there is no definitive method for NRP treatment in current guidelines, methods to predict the success of procedures with NRP are also limited. There is a need for a practical, real-time method for predicting the outcome of procedures in NRP patients. Intracoronary electrocardiography (ic-ECG) which is simple, cost-effective, and a bedside indicator of myocardial ischemia, is proposed as a potential solution in this study.

Purpose

The aim of this study was to examine the potential of ic-ECG in predicting the success of primary percutaneous intervention (pPCI) in patients with STEMI and the development of coronary no-reflow.

Methods

This was a prospective investigation that included 71 patients diagnosed with acute anterior STEMI and underwent pPCI between November 2021 and May 2022. The patients were separated into two groups based on the Thrombolysis in Myocardial Infarction (TIMI) flow grade criteria, with those having a grade of less than 3 defined as NRP. The NRP group was further analyzed to determine the relationship between the percentage of ST-segment resolution (STR) in the ic-ECG records taken during pPCI and short-term major adverse cardiovascular events rates and left ventricular ejection fraction (LVEF) recovery status.

Results

A total of 71 patients, with a mean age of 56.8 years and 76.1% of them being male, were included in the study. Of these patients, 26 were found to have developed NRP, while TIMI-3 flow was observed in 45 patients. In the NRP group, various parameters were found to be associated with LVEF recovery, such as peak troponin value (6267.8±2488.4 ng/ml vs 3244.6±3183 ng/ml, p=0.013) basal low-density lipoprotein cholesterol (LDL-C) (138.8±29.9 mg/dl vs 104.5±40 mg/dl, p=0.021), total cholesterol value (222.7±69.2 mg/dl vs 167.5±44.5 mg/dl, p=0.024), and ic-ECG STR level (21±22.3% vs 65.5±17%, p<0.001). The results of the multivariate analysis and subsequent ROC analysis showed that an ic-ECG STR ratio greater than 42% (sensitivity 100%, specificity 84.6%) was an independent predictive factor for LVEF improvement (Table 1).

Conclusions

The results showed that the STR rate measured by ic-ECG was significantly associated with LVEF recovery and was an independent predictive factor for LVEF recovery with a sensitivity of 100% and specificity of 84.6%. The study highlights the usefulness of ic-ECG in predicting pPCI success in NRP patients and supports its integration into clinical practice.
Single stent versus two stent strategy in primary PCI for unprotected LM occlusion
Authors: Tantawy M , Fouad A
Published: November 2023

Background

Acute MI due to left main coronary artery (LMCA) occlusion carry the highest anatomical risk for morbidity and mortality during primary PCI. Although several clinical trials compared different PCI techniques and strategies for LMCA, still special populations and different clinical scenarios have lack of evidence about ideal approaches.

Purpose

We aim to compare provisional stenting versus two stent upfront technique in acute MI due to LMCA occlusion regarding short term clinical outcomes.

Methods

This was a prospective observational study from three large centers within the period from February 2019 to Feb 2023. Patients with acute STEMI due to LMCA occlusion who are candidates for primary PCI were included and was assigned to two groups according to operator discretion. Group I (provisional stenting) versus group II (upfront two stent strategy). Our primary outcome was MACE within 30 days and secondary Outcomes were angiographic outcomes after intervention including TIMI flow, CTFC and myocardial blush.

Results

A total of 62 patients met our inclusion criteria, mean age (62.64±8.61), 24.6% women. Thirty-eight patients in group I undergone provisional stenting and twenty-four patients in group II undergone two stent strategy. MACE was significantly higher in the two-stent strategy group (61.62% vs 40.34%, P<0.001] compared with provisional stenting group. the IV epinephrine group. Angiographic outcomes were significantly better in provisional stenting group by the end of the procedure. There was marked increase in patients who achieved postprocedural TIMI III and TMPG III in group I by 22% and 18% respectively in comparison with two stent strategy group.

Conclusion

Our observational study concluded that provisional stenting carries better short-term outcomes in acute MI intervention due to unprotected LMCA occlusion. Clinical studies are needy in this specific population.Study flow chartFigure I
Outcomes of chronic total occlussion recanalization in patients with prior bypass-surgery: an updated systematic review and meta-analysis of real world registries
Authors: Romeo F , Moroni F , Del Buono M G , Damonte J I , Chiabrando J G , Azzalini L
Published: November 2023

Background

Recanalization of chronic total occlusion (CTO) coronary lesions by percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafting (CABG) is still considered a challenging scenario due to the complexity of coronary lesions as well as the requirement of CTO PCI advanced techniques. The aim of this study is to compare clinical outcomes of patients undergoing CTO PCI with and without CABG surgery.

Methods

We conducted a systematic review and meta-analysis of observational studies that compared in-hospital outcomes of CTO PCI in patients with vs. without prior CABG published in Medline from inception until December 2022. The results are synthesized in a quantitative manner with random effects models. Categorical variables were compared using the chi-square test, whereas continuous variables were compared using a 2-sample Student's t-test. Statistical heterogeneity was assessed by I2 statistics: I2 statistic >50% was considered substantial, and I2 >75% was considered considerable. The Review Manager Software version 5.3.5. (The Cochrane Collaboration, 2014) was used to calculate summary statistics (odds ratios [ORs] with 95% confidence intervals [CIs]).

Results

Eleven observational studies with a total of 35,666 patients were included, of whom 7,005 patients had a history of CABG. Prior CABG patients were older, (68.1 ± 9.0 vs. 64.1 ± 10.7 years; p < 0.001), and had more complex coronary lesions (J-CTO score: 3.2 ± 1.4 vs. 2.5 ± 1.4; p < 0.001). Prior CABG was associated with lower technical success (66.6% vs. 78.5%; OR 0.53 [95% CI: 0.43 to 0.65]; p < 0.00001, I2 = 84%) as well as lower procedural success (OR 0.64 [95% CI: 0.57 to 0.71]; p < 0.00001, I2 = 0%) as compared with patients with no prior CABG (Figure 1A and Figure 1B). Prior CABG patients had a higher incidence of in-hospital mortality (0.7% vs. 0.4%; OR: 2.00 [95% CI: 1.32 to 3.05]; p = 0.001, I2 = 9%, Figure 2A), coronary perforation (3.7% vs. 2.3%; OR: 1.64 [95% CI: 1.15 to 2.33]; p < 0.006, I2 = 74%, Figure 2B), and myocardial infarction (1.7% vs. 0.7%; OR: 2.57 [95% CI: 1.73 to 3.81]; p < 0.00001, I2 = 12%), but a lower incidence of cardiac tamponade (0.2% vs. 0.9%; OR: 0.36 [95% CI: 0.17 to 0.77]; p = 0.09, I2 = 0%, Figure 2C) compared with those without prior CABG. Both groups had a similar incidence of acute cerebrovascular events (0.2% vs. 0.1%; OR: 1.70 [95% CI: 0.75 to 3.88]; p = 0.21, I2 = 0%), major bleeding (1.4% vs. 1.2%; OR: 1.24 [95% CI: 0.96 to 1.61]; p = 0.09, I2 = 0%) and vascular complications (1.4% vs. 0.9%; OR: 1.50 [95% CI: 0.93 to 2.41]; p = 0.10, I2 = 0%).

Conclusion

Prior CABG patients undergoing CTO PCI presented a higher risk of in-hospital mortality and perioperative procedural complications although the risk of tamponade was lower.Figure 1A and Figure 1BFigure 2A, 2B and 2C
Impact of procedure-related increase in plasma creatinine after transcatheter aortic valve implantation: a nationwide study
Authors: Petersen J , Fosbol E , Bager L G V , Strange J E , Carlson N , Schou M , Kober L , Ostergaard L
Published: November 2023

Background

In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of plasma creatinine (PCreat) increase on the prognosis and on future kidney function is sparsely examined and data from large, nationwide cohorts are warranted.

Purpose

To examine the long-term risk of dialysis treatment, mortality, and major adverse kidney event according to PCreat level increments in the periprocedural setting of TAVI.

Methods

With Danish nationwide registries, we identified all patients undergoing TAVI from 2014–2021. According to two PCreat blood samples (the latest measured value between 365–7 days prior to TAVI and the highest measured value within 21 days after TAVI), patients were classified according to percent increase in PCreat: 1) <25%, 2) 25–49%, and 3) ≥50%. With a maximum of one year of follow-up, we used Aalen-Johanson estimator to examine the cumulative incidence frequency (CIF) of first-time dialysis treatment and major adverse kidney event and Kaplan-Meier estimates to assess all-cause mortality. Major adverse kidney event was defined as either of three: initiation of dialysis treatment, mortality, or an admission with a diagnosis code of acute kidney injury. Adjusted rates of outcomes were assessed, using multivariable Cox analysis, with patients with <25% PCreat increase serving as reference.

Results

We identified 4,029 patients undergoing a first-time TAVI procedure (57.0% male, median age 81 year); 3,343 (83.0%) patients with <25% PCreat increase, 462 (11.5%) with 25–49% PCreat increase, and 224 (5.6%) with ≥50% PCreat increase. Compared with <25% PCreat increase, the adjusted one-year rate of dialysis treatment showed no statistical difference in patients with 25-49% PCreat increase (hazard ratio [HR] 1.52 [95%CI, 0.74–3.11]), while patients with ≥50% PCreat increase had an increased associated one-year rate of dialysis treatment (HR 3.62 [95%CI, 1.90–6.90]) (Figure). The adjusted one-year rate of mortality was increased in both patients with 25-49% PCreat increase (HR 1.78 [95%CI, 1.29–2.45]) and ≥50% PCreat increase (HR 2.87 [95%CI, 1.97–4.18]). The adjusted one-year rate of major adverse kidney event was increased in both patients with 25-49% PCreat increase (HR 1.69 [95%CI, 1.25–2.28]) and ≥50% PCreat increase (HR 3.03 [95%CI, 2.17–4.23]).

Conclusion

In patients undergoing TAVI, a PCreat increase of ≥25% was associated with increased one-year rates of mortality and major adverse kidney event, while an increase ≥50% carried a more than threefold increased rate of incident dialysis treatment and increased rates of mortality and major adverse kidney event.
Valve-in-valve transcatheter aortic valve implantation for degenerative stentless versus stented surgical bioprostheses
Authors: Steul J , Abdel-Wahab M , Stankowski T , Haussig S , Woitek F , Gasior T , Crusius L , Knorr L , Mueller F , Kiefer P , Kappert U , Holzhey D , Linke A , Mangner N
Published: November 2023

Introduction

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in failing stented bioprosthetic valves; stentless bioprostheses lack fluoroscopic markers and could be more challenging for transcatheter therapy. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce; thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of patients with stentless (SL) versus stented (ST) aortic bioprosthetic device failure undergoing ViV-TAVI.

Methods

Patients undergoing ViV-TAVI between 2007 and 2022 (53% of cases after 2015) at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety.

Results

Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age (SL: 77 (74; 82) vs. ST: 78 (75; 83), p=0.08), sex (male: SL 70% vs. ST 56%, p=0.08), clinically relevant baseline comorbidities and surgical risk (STS PROM SL 10.0 (4.8; 12.5) % vs. ST 9.4 (4.5; 11.3) %, p=0.62). Aortic regurgitation was the mode of failure in 33% of SL vs. 8% in ST (p<0.01). The rate of self-expanding TAVI prostheses was 86% and 76% in SL and ST, respectively (p=0.15). The rates of technical success (SL: 84% vs ST: 80%, p=0.55), device success (SL: 67% vs ST: 54%, p=0.11), and early safety (SL: 74% vs ST: 62%, p=0.30) were comparable between groups. There were higher rates of mild/moderate residual aortic regurgitation in SL (77.5% vs. 35%, p<0.01), whereas the remaining mean gradient was higher in ST (11.2 (6.0; 15.5) mmHg vs. 17.0 (11.0; 22.0) mmHg, p<0.01). The 30-day mortality rate (SL: 7.0% vs. ST: 2.6%, p=0.14) and Kaplan-Meier estimated 1-year mortality rates (SL: 9.3% vs. ST: 8.2%, p=0.63) were comparable between groups.

Conclusion

Both SL and ST ViV-TAVI have comparable short-term outcomes according to VARC-3- defined endpoints and similar low rates of 1-year all-cause mortality. However, against the background of a relevant rate of residual aortic regurgitation in SL and increased gradients in ST, long-term studies are of utmost importance to determine the clinical relevance of those factors.
Self-expanding or balloon-expandable transcatheter aortic valve replacement in a German comparison
Authors: Oettinger V , Hilgendorf I , Wolf D , Rilinger J , Stachon P , Kaier K , Zehender M , Westermann D , Von Zur Muehlen C
Published: November 2023

Background

Studies demonstrated that results for self-expanding vs balloon-expandable transcatheter aortic valve replacement (TAVR) are similar, with larger subgroup analyzes missing.

Methods

We identified 46,243 self-expanding (SE) and balloon-expandable (BE) transfemoral TAVR for aortic stenosis in German hospitals in 2019 or 2020. Both in-hospital outcomes as well as subgroups for in-hospital mortality were analyzed.

Results

Regarding baseline characteristics, the logistic EuroSCORE was higher in SE (SE 13.6% - BE 12.7%; p<0.001), which also applied to age (SE 81.6a - BE 80.0a; p<0.001). There was a comparable in-hospital mortality rate in both groups (BE 2.37% - SE 2.35%; p=0.916). Risk adjusted in-hospital mortality was also not significantly different (OR=0.98, p=0.799). The SE group presented a significantly lower risk of major bleeding events (OR=0.83, p=0.006), however, there was a significantly higher risk of stroke (OR=1.38, p<0.001), risk of delirium (OR=1.15, p=0.001) as well as risk of permanent pacemaker implantation (OR=1.29, p<0.001). No difference has been found for acute kidney injury, mechanical ventilation >48h, length of hospital stay, and reimbursement. In addition, the subgroups showed no significant differences for in-hospital mortality regarding age, logistic EuroSCORE, gender, heart failure NYHA III/IV, previous coronary artery bypass graft, peripheral vascular disease, chronic obstructive pulmonary disease, pulmonary hypertension, renal disease GFR <30ml/min or diabetes mellitus.

Conclusion

Self-expanding or balloon-expandable TAVR did not show significant differences for in-hospital mortality in a subgroup analysis in Germany.
Analyzing current German transcatheter and surgical aortic valve replacement practices in pure aortic regurgitation
Authors: Oettinger V , Hilgendorf I , Wolf D , Kaier K , Stachon P , Heidenreich A , Zehender M , Westermann D , Von Zur Muehlen C
Published: November 2023

Background

In Germany, the use of transcatheter aortic valve replacement (TAVR) for treating pure aortic regurgitation is still not regular practice.

Purpose

Therefore, the current development of TAVR in aortic regurgitation is to be investigated.

Methods

In 2018–2020, 4,025 surgical aortic valve replacements (SAVR), 50 transapical, 329 balloon-expandable transfemoral, and 457 self-expanding transfemoral TAVR in pure aortic regurgitation were studied using multivariable logistic and linear regressions.

Results

The TAVR groups had a higher age than SAVR (76.0-77.3a vs 62.8a) and logistic EuroSCORE (17.7-19.1 vs 4.9%). Unadjusted in-hospital mortality was highest in transapical TAVR (6.0%), followed by SAVR (5.7%), and it was lowest in transfemoral TAVR, with self-expanding procedures (2.4%) showing significantly lower in-hospital mortality than balloon-expandable (5.2%; p=0.039). After risk adjustment, we saw a significant association with lower mortality rates for balloon-expandable as well as self-expanding transfemoral TAVR vs SAVR (balloon-expandable: OR=0.50, p=0.031; self-expanding: OR=0.20, p<0.001). In the same way, we found that other examined outcomes were significantly in favor of TAVR: stroke (balloon-expandable: OR=0.17, p<0.001; self-expanding: OR=0.17, p<0.001), major bleeding (balloon-expandable: OR=0.04, p<0.001; self-expanding: OR=0.03, p<0.001), delirium (balloon-expandable: OR=0.19, p<0.001; self-expanding: OR=0.16, p<0.001), mechanical ventilation >48h (balloon-expandable: OR=0.09, p<0.001; self-expanding: OR=0.06, p<0.001), and length of hospital stay (balloon-expandable: Coefficient=-6.88d, p<0.001; self-expanding: Coefficient=-7.22d, p<0.001).

Conclusion

Despite lower procedure volumes in TAVR vs SAVR for pure aortic regurgitation, we see lower rates of in-hospital mortality and complications, suggesting that TAVR can be used successfully in selected patients with aortic regurgitation.
Protecting the vulnerable during a crisis - TAVR during the COVID-19 pandemic
Authors: Zaka A , Mridha N , Abtahi J , Anderson S , Murdoch D
Published: November 2023

Introduction

The coronavirus (COVID-19) pandemic has been challenging for healthcare systems globally. Patients with symptomatic severe aortic stenosis awaiting transcatheter aortic valve replacement (TAVR) are a vulnerable, elderly subset of patients often with multiple comorbidities. Untreated severe aortic stenosis (AS) is associated with a poor prognosis. It is uncertain if population-based strategies to mitigate COVID-19 spread such as delaying elective procedures and virtual consultations have resulted in increased morbidity or mortality in this subset of patients. Position statements guiding TAVR during the COVID-19 pandemic have suggested fewer and shorter hospital admissions. We evaluated the available literature and performed a systematic review and meta-analysis assessing the impact of the COVID-19 pandemic on referral times, hospital stays and mortality in patients awaiting TAVR.

Methods

This systematic review and meta-analysis (CRD42022379840) is reported according to PRISMA guidelines. A comprehensive search strategy with computer- based search was performed using PubMed, Ovid MEDLINE, EMBASE and Cochrane databases. No time limit to start date was applied, and the search was conducted up to 28 November 2022. Only studies with available comparative data to pre-COVID 19 cohorts were included.

Results

Eleven studies satisfied our inclusion criteria, with a pooled analysis of 79785 TAVR patients. Patients undergoing TAVR in the COVID-19 era were associated with a modest risk of all-cause mortality (unadjusted RR: 1.41, 95% CI 0.97-2.06) however this was not statistically significant (Figure 1) and substantial heterogeneity was observed (p<0.01 and i2 = 84%). Patients undergoing TAVR in the COVID-19 cohort trended towards shorter average lengths of stay and time from referral to procedure than TAVR patients prior to the pandemic (mean difference -0.37, 95% CI -0.93 – 0.19 and mean difference -25.43, 95% CI -52.31 to 1.44 respectively), however this was not significant.

Conclusion

This systematic review suggested a trend towards increased all-cause mortality in TAVR patients in the COVID-19 era. Furthermore, the available data trended towards shorter times from referral to TAVR and a shorter average length of stay, consistent with published recommendations from European and Asian expert consensus papers. Our data did not reach statistical significance and showed significant heterogeneity, likely reflecting widespread institutional variations during the pandemic. As the COVID-19 dynamic changes, further data is required to help characterise and optimise patient care in this vulnerable patient group.
Quantitative fluid overload in severe aortic stenosis refines cardiac damage and associates with worse outcomes
Authors: Halavina K , Koschutnik M , Dona C , Mascherbauer K , Heitzinger G , Dannenberg V , Hofer F , Winter M P , Treibel T A , Mascherbauer J , Goliasch G , Hengstenberg C , Kammerlander A A , Bartko P E , Nitsche C
Published: November 2023

Background

Cardiac decompensation in aortic stenosis (AS) involves extra-valvular cardiac damage (CD) and progressive fluid overload (FO). FO can be objectively quantified using bioimpedance spectroscopy (BIS).

Objectives

We aimed to assess the prognostic value of FO beyond established CD markers to guide risk stratification.

Methods

Consecutive patients with severe AS scheduled for transcatheter aortic valve implantation (TAVI) underwent prospective risk assessment with BIS and echocardiography. FO by BIS was defined as ≥1.0L (0.0L=euvolemia). The extent of CD was assessed by echocardiography according to an established staging classification. Right-sided CD (rCD) was defined as pulmonary vasculature/tricuspid/right ventricular CD. Heart failure hospitalization (HHF) and/or death served as primary endpoint.

Results

In total, 880 patients (81±7y/o, 47% female) undergoing TAVI were included. 360 (41%) had FO. Clinical examination in patients with FO was unremarkable for congestion signs in >50%. A quarter had FO but no rCD (FO+/rCD-). FO+/rCD+ had the highest CD markers, including NT-proBNP levels.

After 2.4±1.0 years of follow-up, 236 patients (27%) had reached the primary endpoint (29 HHF, 194 deaths, 13 both). Quantitatively, every 1.0L increase in BIS was associated with a 12% increase in event hazard (adjHR 1.12, 95% CI 1.05-1.20, P=0.001). FO provided incremental prognostic value to traditional risk markers (NT-proBNP, EuroSCORE-II, CD on echocardiography). Stratification according to FO and rCD yielded worse outcomes for FO+/rCD+ and FO+/rCD-, but not FO-/rCD+, compared to FO-/rCD-.

Conclusion

Quantitative FO in patients with severe AS improves risk prediction of worse post-interventional outcomes compared to traditional risk assessment.
Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement
Authors: Beneki E , Dimitriadis K , Tsiachris D , Aznaouridis K , Sakalidis A , Mantzouranis M , Soulaidopoulos S , Papanikolaou A , Tsioufis P , Aggeli K , Tsiamis E , Tsioufis K
Published: November 2023

Background

Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine.

Purpose

The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist.

Methods

Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement.

Results

The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF>30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score.

Conclusions

Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.
Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure
Authors: Bouziri N , Guedeney P , Malvy J , Zeitouni M , Mertens E , Ceccaldi A , Wallet T , Djebbar R , Silvain J , Montalescot G , Hammoudi N
Published: November 2023

Introduction

The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA.

The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA.

Methods

This retrospective single-center observational study included all consecutive patients admitted to our hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO’s morphological characteristics and patient’s choice.

The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications.

Results

A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (p=0.04), reflecting cases selection on the basis of prior TEE.

Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (p=0.27). Procedural duration was shorter with micro-TEE guidance (median time 8 (7-11)min versus 21 (16-27)min, p=0.01). The rate of peri-procedural complications was low (1.3% overall) and limited to periprocedural atrial arrhythmia, without significant differences in both groups (p>0.99).

Conclusions

Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA.These results obtained on selected patients must be confirmed on larger cohorts.
Long term follow-up of patent foramen closure due to embolic infarction in elderly patients
Authors: Hamm C H , Hamm C , Doerr O , Gruen D
Published: November 2023

Background

In patients < 60 years (yrs) with crytogenic embolism associated with a patent foramen ovale (PFO) guidelines recommend interventional closure based on several randomized studies. There is no recommendation for elderly patients, although they seem to carry a similar risk for recurrent events. There are only scarce data on early and particularly late outcome.

Methods

We therefore retrospectively analyzed the up to 10 years outcome (median 4,2 yrs) in 444 consecutive patients (female, male) according to age at PFO closure.

Results

From 444 patients in our study population, 155 were >60 years of age (mean age 66,7 (IQR 63,1-71,74), 45% females. Older patients had higher prevalence of cardiovascular risk factors like hypertension, hyperlipidemia and diabetes (p< 0,01 for all vs. younger patients) while smoking was more prevalent in younger patients (p<0,01). No difference in procedural success and periinterventional complications was observed between the two age groups. During follow up of median 4,2 years (5 patients lost to FU) event rate of recurrent stroke, atrial fibrillation and acute myocardial infarction did not differ between older and younger patients.

Conclusions

Long term outcome was independent of age despite higher CV risk factors burden and supports PFO closure in elderly patients.