Journal of Interventional Cardiology

Background: Coronary lesions with significant angulation or tortuosity pose unique challenges during intervention due to limited access and maneuverability. The SuperCross microcatheter (SCM) is specifically designed to navigate through these angulated vessels and facilitate the successful crossing of side branches. Objectives: The objective of this article is to formulate and discuss recommendations for the primary use of SCM in coronary intervention involving complex coronary anatomy. Methods: From January 2021 to December 2023, a total of 43 patients underwent treatment at our single center utilizing SCM techniques. The duration of the treatment period was categorized into two distinct phases: primary use and secondary use of SCM. Results: The average age of the patients was 68.5 ± 10.6 years, with a predominance of male patients. The primary diagnosis consisted of unstable angina. Due to limited accessibility and maneuverability, there were frequent attempts made at the ostium of the left circumflex artery (30.2%), diagonal branch ostium (27.9%), and obtuse marginal branch ostium (14.0%). However, three cases failed to successfully navigate through highly angulated lesions. Conclusions: The utilization of SCM techniques offers distinct advantages in managing complex coronary anatomies, particularly when dealing with highly angulated vessels observed in bifurcation or chronic total occlusion scenarios, as well as facilitating antegrade dissection for re‐entry into the true lumen.

Background and Aims: Breast cancer (BC) is the leading cause of cancer in women. Female interventional cardiologists are potentially at a higher risk of developing BC due to occupational radiation exposure. This survey aimed at understanding radiation safety and awareness in current clinical practice, and the occurrence of BC, among female interventional cardiologists. Methods: A survey was conducted worldwide among 64 cardiac laboratories from September 2022 to December 2022. Results: 195 physicians (mean age 41.0 ± 7.4 years) completed the survey: 33 (16.9%) reported being exposed to X‐ray for less than five years, 78 (40%) between five and ten years and 84 (43.1%) for more than ten years; 13 (6.7%) reported performing less than 50 interventional procedures/year, 52 (26.7%) between 50 and 100 and 130 (66.6%) more than 100 procedures/year. 126 physicians reported wearing three or more radiation dosimeters; 72 reported not using tableside X‐ray shielding to protect themselves from direct and scattered radiation. BC occurred in four (2.1%) physicians, all of whom worked in the electrophysiology laboratory for a relatively long time (one with 5–10 years of exposure and three with more than ten years; mean age at cancer presentation was 46.5 ± 3.7 years). All tumours were left‐sided BC. Conclusions: This survey provides a snapshot of occupational radiation exposure of female interventional cardiologists. BC is a possible professional threat in addition to its real‐life epidemiology, with a negative impact on women’s lives in interventional laboratories. All possible efforts should be made to eliminate radiation exposure among interventional laboratory workers.

Introduction and Objectives: Coronary artery perforation (CAP) is a rare but potentially fatal complication of percutaneous coronary intervention (PCI). Although its management is well‐studied in tertiary care settings, little is known about the incidence and treatment patterns at district general hospitals (DGHs), which this study explored. Materials and Methods: A single‐centre analysis of all PCI procedures in a DGH between January 2011 and December 2023 was performed. Patients’ records were examined for procedure details and endpoints, which included pericardiocentesis, emergency cardiac surgery and secondary coronary artery bypass grafting. The endpoints also included in‐hospital and one‐year mortalities. Results: During the study period, there were 13,480 PCIs, of which 31 (0.23%) were complicated by CAP. Males composed 65%, and the mean age was 69.9 ± 10 years. The most common perforation type was Ellis II in 45% of patients, and the left anterior ascending artery (LAD) was most affected in 55% of patients. An echocardiogram was done in all patients and showed tamponade physiology in 16%, in all of whom pericardiocentesis was performed. Other CAP treatments included balloon tamponade in 65%, covered stent in 42%, fat embolisation in 10% and emergency surgery and coiling in 6% each. Inpatient mortality occurred in three patients (10%), with no one‐year mortalities. Long‐term complications were not observed in the study. Conclusion: CAP remains a rare, potentially lethal complication of PCI in a DGH setting, with an incidence, pattern and treatments similar to those of high‐volume PCI teaching centres. Early recognition and proper management are crucial.

Objective: To compare left ventricular (LV) and aortic (AO) pressures obtained using fluid‐filled and high‐fidelity solid‐state pressure catheters in subjects undergoing left heart catheterization. Materials and Methods: Twenty subjects scheduled for a left heart catheterization were enrolled and 18 subjects completed this IRB‐approved study. LV and AO pressures were obtained using fluid‐filled pressure catheter (standard‐of‐care) and high‐fidelity solid‐state pressure catheter synchronously. Pressure tracings were analyzed to measure LV systolic (LVSP), LV minimum‐diastolic (LVMDP), LV end‐diastolic (LVEDP), AO systolic (AOSP), and AO diastolic (AODP) pressures. Isovolumic contraction and relaxation rates (peak ± dp/dt) were derived from the pressure waveforms. Repeated measures of variance, post hoc tests with Bonferroni corrections, and Bland–Altman plots were used for comparisons. Results: A significant main effect of the pressure catheter was noted for LVSP, LVMDP, and AOSP ( p ≤ 0.025). The LVSP and AOSP measured with fluid‐filled pressure catheters were higher by 6.6 ± 6.9 mmHg and 4.6 ± 5.2 mmHg in comparison to solid‐state pressure catheter. In contrast, the LVMDP measurements were 3.5 ± 5.7 mmHg lower than the solid‐state pressure catheter measurements. The isovolumic contraction (66.4 ± 116.0 mmHg/s) and relaxation rates (60.5 ± 113.5 mmHg/s) were not significantly different between catheter systems after Bonferroni corrections for multiple comparisons ( p ≥ 0.06). The Bland–Altman analysis revealed a bias ranging from 0.8 to 6.6 mmHg. Conclusions: Differences in LVSP, LVMDP, and AOSP were noted between the catheter systems but not for other pressure values and contraction/relaxation rates. Fluid‐filled catheters overestimated true systolic pressures in the left ventricle and aorta. Trial Registration: ClinicalTrials.gov identifier: NCT03245255

Background: The shorter time to hemostasis in patients who undergo transradial cardiac catheterization may reduce the complications, cause less pain, facilitate early discharge, and improve patient satisfaction. Objective: This trial aimed to evaluate if SoftSeal-STF (Chitogen Inc., Plymouth, MN) with manual compression alone or in combination with a radial compression device (RCD) would reduce time to hemostasis compared to patients with RCD only (Vasc Band). Methods: We enrolled 300 patients in four arms, including SoftSeal-STF with manual compression, Vasc Band (standard of care), SoftSeal-STF with TR Band, and SoftSeal-STF with EasyClik. This study was analyzed as an observational study due to modification in the design of a randomized trial. The primary outcome was time to hemostasis; the secondary outcomes were complications before discharge, a 3 day follow-up, and a follow-up office visit (30–45 days postprocedure). Results: The median time to hemostasis (interquartile range [IQR]) was significantly lower in the SoftSeal-STF + TR Band group and the SoftSeal-STF + EasyClik group than in the Vasc Band group (45 [40–69] minutes vs. 120 [120–124] minutes, p<0.0001; 44 [40–58.5] minutes vs. 120 [120–124] minutes, p<0.0001, respectively). The median time to hemostasis (IQR) was not different between SoftSeal-STF + TR Band and SoftSeal-STF + EasyClik (45 [40–69] minutes vs. 44 [40–58.5] minutes, p=0.3). The median time to hemostasis (IQR) was lowest in the SoftSeal-STF + manual compression group (19 [15–30] minutes), but these patients had more postoperative pain and bruising along with logistic issues within the catheterization lab. Conclusion: The SoftSeal-STF + RCD is a safe and time-efficient strategy in patients who undergo transradial cardiac catheterization. (Radial Artery Vascular Complication and Resource Utilization [RAVE]). Trial Registration: ClinicalTrials.gov identifier: NCT03522077

Objective: The results of right-to-left shunt (RLS) assessments are highly influenced by the methods used. This study aimed to compare the effectiveness of contrast transthoracic echocardiography (cTTE) and contrast transcranial Doppler (cTCD) in detecting RLS by conducting them simultaneously, employing the same provocations, timing, contrast-saline mixture, and posture. Materials and Methods: This study was conducted at the Second Affiliated Hospital, School of Medicine, the Chinese University of Hong Kong, Shenzhen. A total of 237 patients who underwent both cTTE and cTCD simultaneously were included. The differences in RLS detection rates and the degree of shunting between the two examinations were assessed using the chi-square test and Wilcoxon rank-sum test. In addition, the timing of RLS appearance was compared between cTTE and cTCD examinations. Results: The detection rate of RLS was higher with cTTE compared to cTCD (93.25% vs. 84.81%, X2 = 8.64, p=0.03); the difference was primarily observed in cases where RLS appeared after five cardiac cycles (X2 = 17.496, p<0.001). Regarding the detection of moderate/large shunts, cTTE outperformed cTCD (66.67% vs. 30.38%, X2 = 62.468, p<0.001); the difference in moderate/large shunt detection rates was primarily observed in cases where RLS appeared after five cardiac cycles (X2 = 86.361, p<0.001). Conclusion: During the synchronous provocation testing, cTTE demonstrated superior performance over cTCD in detecting RLS and moderate/large RLS, particularly when RLS appeared after five cardiac cycles following full right atrial opacification.

Background: Transradial coronary intervention has been shown to be both safe and effective, with several benefits, such as limited access to site complications and earlier patient discharge. Radial compression devices, on the other hand, add to the total expense of the procedure and have not been adequately compared to traditional compressive dressings. The purpose of this study is to compare the safety and efficacy of elastic compressive dressing with gauze swabs and crepe bandages to balloon compression devices with the TR Band (Terumo) for maintaining radial hemostasis following cardiac procedures. Method: A total of 402 patients were randomly assigned to receive either a TR band or an elastic compressive dressing for radial hemostasis following cardiac intervention in a prospective, partially blinded, randomized clinical study. The main outcome was the hemostasis time and the occurrence of hematoma. Patient satisfaction, postprocedure pain, vascular problems, and the cost of the compression device used were all secondary outcomes. Results: The two groups had similar baseline characteristics and procedural data. The majority of patients (79%) were very satisfied with both hemostasis techniques. The elastic dressing group achieved hemostasis significantly faster than the TR band group (83.8 ± 142.8 min vs. 116.3 ± 122.7, p=0.017). Significant differences in the incidence of hematoma (8% elastic dressing vs. 18.4% TR band, p=0.003) and postprocedural pain (0.84 ± 1.2 elastic dressing vs. 1.39 ± 1.4 TR band, p≤0.001) were observed. The incidence of early radial artery occlusion was higher in the elastic dressing group (7 patients) than in the TR band group (2 patients), although the difference was not statistically significant (p=0.09). Finally, the TR band was significantly more expensive than the elastic dressing used in the trial. Conclusion: Elastic compressive dressings are a safe, low-cost, and effective alternative to TR band. They decrease hemostasis time, enhance patient comfort, and reduce both the number and size of hematomas. When compared to the TR band, these dressings have a similar rate of radial artery patency at discharge. Trial Registration: ClinicalTrials.gov identifier: NCT05409716

Background: Gender differences exist in atrial fibrillation (AF) regarding epidemiology, mechanisms, management, and outcomes. There are limited data regarding gender-specific outcomes after pulmonary vein isolation (PVI) including AF recurrence, physical activity, and health-related quality of life. Methods: In this secondary analysis of a randomized controlled trial (BE-ACTION study: investigating 200 patients with paroxysmal or persistent AF undergoing PVI), a gender-specific analysis of the primary endpoint (recurrence of atrial arrhythmia > 30s, additional ablation procedure, or new onset of antiarrhythmic drugs) was performed. Quality of life was assessed using the AFEQT and SF-36 questionnaires, while physical activity was measured via step counts recorded at baseline, 6 months, and 12 months. The Mann–Whitney U test and Fisher exact test were used to compare continuous and categorical variables, respectively. Results: 33.5% were women. Women and men were comparable in demographics, comorbidities, and steps per day before and after PVI. There was no statistically significant difference in the primary composite endpoint between women (37.3%) and men (25.6%) (p=0.085). Before PVI, women had lower quality of life scores than men (median AFEQT scores: 43.5 points [25th to 75th percentiles 25.9–63.9] vs. 62.0 points [47.2–76.4], respectively, p<0.001) as well as in the physical (40.22 points [33.98–46.69] vs. 46.30 points [39.21–51.60], p=0.002) and mental domains (42.33 points [27.34–51.59] vs. 49.59 points [36.02–55.64], p=0.001) of the SF-36 questionnaire. The overall improvement in the quality of life was significant for both men and women (p<0.001). Using AFEQT, women exhibited lower quality of life scores compared to men at 6 months post-PVI (p=0.001); however, this difference was no longer statistically significant at 12 months (p=0.077). Conclusion: These data emphasize the importance of AF recurrence after PVI and motivate future research to explore the causes and clinical consequences of a gender gap in quality of life in women after PVI. Trial Registration: WHO International Registry of Clinical Trials: DRKS00012914

Objectives: The mortality of ST elevation myocardial infarction (STEMI) has plateaued in the last decade, with a 30-day mortality of 3%-4%. Previous studies in patients with anterior STEMI treated by primary angioplasty and assisted with the pressure-controlled intermittent coronary sinus occlusion (PiCSO) system have shown a modest but significant absolute reduction of the infarct zone. Methods: Prospective, observational study were carried out in two hospitals in Spain. The study included patients with acute coronary syndrome and patients with high-risk percutaneous coronary intervention (PCI). PiCSO therapy was provided throughout the PCI (after achieving thrombolysis in myocardial infarction [TIMI] flow two or three in STEMI cases), with a minimum duration of 20 min from stent implantation until the completion of the procedure. Results: A total of 22 cases were performed. In 20 cases, PiCSO therapy could be successfully applied, and in 2 cases, it was not possible due to the inability to access the coronary sinus. In 95.45%, the PCI was performed in a single coronary artery. Baseline TIMI flow was 0-1 in > 60% of patients, with final TIMI 3 flow achieved in > 95%. There were no complications secondary to the use of the PiCSO system. At 6-month clinical follow-up, 100% of the patients were alive with significant improvement in functional class and angina status. Conclusions: The use of the PiCSO device during ACS was safe and may offer potential benefits to patients susceptible to reperfusion injury or in whom relevant distal microembolization is anticipated during primary angioplasty or high-risk PCI. More data are needed to validate its widespread clinical use.

Background: It is generally accepted that for patients with multivessel disease and myocardial infarction, complete revascularization is preferable than culprit-only revascularization. However, existing studies comparing coronary physiology-guided versus angiography-guided complete revascularization percutaneous coronary intervention (PCI) present conflicting conclusions. Methods: The investigation involved a comprehensive search of PubMed/Medline, Embase, and the Cochrane library for studies comparing coronary physiology-guided with angiography-guided PCI in patients with MI-MVD. Clinical endpoints, including major adverse cardiovascular events, all-cause mortality, recurrent MI, major adverse cardiac and cerebral event, planned revascularization, repeated revascularization, average stent number per patient, heart failure, and contrast nephropathy during any follow-up period post PCI, were considered for analysis. Odds ratios (ORs) and mean differences with 95% confidence intervals (CIs) were calculated for binary and continuous variables, respectively. The analyses were conducted using Review Manager 5.1. Results: Our analysis included a total of 2493 patients from 5 studies. The physiology-guided PCI group exhibited a lower rate of planned revascularization (OR: 0.10, 95% CIs: 0.07–0.14, p≤0.001, and I2 = 96.6%) and average stent number per patient (mean difference: −0.47, 95% CIs: −0.56–−0.38, p≤0.001, and I2 = 58.6%). However, there were no significant differences between the two groups regarding major adverse cardiac event (MACE) (OR: 0.89, 95% CIs: 0.63–1.26, p=0.520, and I2 = 67.8%), all-cause mortality (OR: 0.65, 95% CIs: 0.38–1.12, p=0.120, and I2 = 50.5%), recurrent MI (OR: 0.74, 95% CIs: 0.28–2.00, p=0.558, and I2 = 77.2%), major adverse cardiac and cerebral event (MACCE) (OR = 0.77, 95% CIs: 0.43–1.37, p=0.378, and I2 = 0%), repeated revascularization (OR = 1.47, 95% CIs: 0.54–3.99, p=0.452, and I2 = 76.5%), heart failure (OR: 1.04, 95% CIs: 0.43–2.56, p=0.924, and I2 = 0%), and contrast nephropathy (OR: 1.26, 95% CIs: 0.27–5.81, p=0.766, and I2 = 0%). Conclusions: Among patients with MI-MVD, physiology-guided PCI appeared to reduce the need for planned revascularization without triggering repeated revascularization, leading to fewer stents compared with angiography-guided PCI. Other prespecified clinical outcomes including MACE, all-cause mortality, recurrent MI, MACCE, heart failure, and contrast nephropathy were not significantly different between these two approaches.

Background: Mitral transcatheter-edge-to-edge-repair (M-TEER) is mostly done with using general anesthesia (GA). Limited data including specific risk factors exist for a deep sedation (DS) approach. Methods and Results: 464 M-TEER procedures were included for comparison of a DS approach versus those who required a conversion to GA. Specific predefined risk factors were analyzed to identify those patients who might not benefit from a DS strategy by the need of conversion to GA. The conversion rate from DS to GA was 6.7% (n = 433 successful DS and n = 31 conversion to GA). Mean age was 80 years. Classical surgical risk scores did not show any significant difference between the two groups. Patients with DS had a higher procedural success rate (96.1% versus 80.1%; p<0.001). The time on the intensive care unit (ICU) (3.9 h versus 126 h; p=0.023) was shorter for patients with DS. Patients who were in the need for a conversion to GA had a lower 30-day and 1-year survival rate. A multivariate analysis for conversion to GA showed body mass index (p=0.023), pre-existing kidney failure (p<0.001), obstructive sleep apnea syndrome (OSAS) (p=0.031), systolic pulmonary pressure value (p=0.013), and concomitant tricuspid regurgitation (p=0.049) as risk factors. Conclusions: Using DS in M-TEER is feasible with a low conversion rate to GA. In case of a conversion, the procedure is less successful regarding reduction of MR and more complications occurred with a lower survival rate up to 12 months. These data suggest that conversion from DS to GA is high risk. Therefore, we could identify different predictors for the need of a conversion to GA. However, our results could only be hypothesis-generated and should be evaluated in a randomized study.

Temporary mechanical circulatory support (tMCS) devices are a critical component for treating patients with cardiogenic shock (CS). We analyzed use of Impella 5.5 device for efficacy and safety in a single-center CS population from February 2022 and April 2023. Thirty-six CS patients received Impella 5.5 support for a median duration of 16 (2, 63) days, during a median hospital stay of 40 (4, 97) days, with an overall survival (OS) of 69%. While 18 patients received Impella 5.5 only, 11 patients received Impella 5.5 as part of a de-escalation strategy, and 7 patients escalated from Impella CP only to Impella 5.5. At the time of implant, creatinine was 1.5 (0.6, 5.2) mg/dL and normalized to 1.1 (0.6, 7.7) mg/dL at discharge. In a subset of CS transfer patients (n = 12), median duration of support was 16 (1, 31) days, duration of hospital stay was 43 (8, 88) days, and OS was 67% (8/12). Collectively, these data demonstrate that Impella 5.5 support is safe and effectively improves laboratory values and survival outcomes in both transfer and in-house patients with CS.

Background: Despite the enormous impact of heart failure (HF) in China, there is a relative lack of research on its epidemiologic trends and burden. Therefore, there is an urgent need for a comprehensive and in-depth analysis of the epidemiologic patterns, underlying etiology, and overall burden of HF. Objective: This study aimed to elucidate the epidemiology, etiology, and burden of HF in China and provided a comprehensive and up-to-date analysis, including temporal trends from 1900 to 2019. Methods: The data for this study were derived from the Global Burden of Disease (GBD) study 2019. Descriptive analyses were conducted to examine the prevalence and years lived with disability (YLD) rates in China from 1990 to 2019, with variables including year, sex, and age. To illustrate the temporal trend spanning 1990 to 2019, estimated average annual percentage changes (AAPC) were calculated. Results: In 2019, the number of prevalent HF cases in China was 18.51 million (95% uncertainty interval [UI]: 14.97 to 23.02 million), representing 32.9% of the global prevalence. Between 1990 and 2019, the number of cases and the prevalence rates of HF in China showed an increasing trend. The age-standardized prevalence rates (ASPRs) demonstrated an overall declining trend (AAPC = −0.16, 95% confidence interval [CI]: −0.19 to −0.13, p<0.01), as did the age-standardized YLD rates (AAPC = −0.13, 95% CI: −0.16 to −0.1, p<0.01). However, from 2017 to 2019, a gradual increase was observed (AAPC = 1.72, 95% CI: 1.47 to 1.96, p<0.01). In the age-based analysis, individuals aged 55 years and older accounted for 88.3% of the prevalent cases. Women exhibited higher case numbers and ASPR compared to men. In the cause-based analysis, hypertensive heart disease emerged as the primary etiology of HF in China. Conclusion: From 1990 to 2019, the ASPR and age-standardized YLD rates for HF in China demonstrated an overall decreasing trend. Nevertheless, the trend increased from 2017 to 2019, with significant variations observed by gender and age. Therefore, continued attention to the disease burden of HF in China remains essential. Healthy lifestyles are important for minimizing the prevalence of HF. In addition, it is necessary to address and reduce the incidence of hypertension from all causes to mitigate the disease burden further.

Objective: To compare the efficiency and safety of primary and bailout antegrade dissection and re-entry (ADR) during percutaneous coronary intervention (PCI) for chronic total occluded (CTO) lesions. Methods: Patients who underwent ADR procedures for CTO lesions were enrolled in this study and were divided into two groups (primary ADR and bailout ADR) based on the initiation of ADR during PCI. The success rate and major adverse cardiovascular and cerebrovascular events (MACCE) during hospitalization were assessed as the primary endpoints. Procedure time, fluoroscopy time, wire crossing time, radiation dose, and contrast volume were considered as secondary endpoints. Results: A total of 243 patients were enrolled in this study, with 127 patients receiving primary ADR and 116 receiving bailout ADR. No differences were found in baseline parameters between the two groups. The success rate was significantly higher in the primary ADR group compared to the bailout ADR group (89.0% versus 77.6%, respectively; p=0.017). The incidence of in-hospital MACCE was low in both groups, with no significant differences observed between them. Procedure time, radiation dose, and contrast volume were lower in the primary ADR group compared to the bailout ADR group. Cox regression analysis revealed that primary ADR and J-CTO score ≥ 3 were independent predictors of technical success in CTO-PCI. Conclusions: Both primary and bailout ADR are safe strategies for CTO-PCI. Primary ADR significantly improves the success rate of PCI for CTO compared to bailout ADR, with shorter operation time, lower radiation dose, and reduced contrast volume.

Background: The safety of new-generation mobile phones using 5G networks in patients with modern-generation pacemakers has not been studied. Objectives: This study aimed to compare the risk of electromagnetic interference (EMI) generated by a new-generation mobile phone with 5G networks when positioned at the pacemaker pocket or the contralateral ear and assess the incidence of EMI with telemetry interrogation in patients with permanent pacemakers. Methods: We enrolled 489 patients with pacemakers from three different manufacturers. The pacemaker mode was programmed for overdrive pacing and sensing mode if an intrinsic rhythm was present. A smartphone (Samsung S21 + 5G) was placed directly over the pulse generator and right ear. The phone was tested under standby mode, 5G internet connection, and incoming and outgoing calls for each location. Real-time electrocardiography (ECG) monitoring and patient symptoms were recorded to determine the occurrence of EMI. The possibility of EMI with interrogation telemetry was also investigated. Results: A total of 4824 tests were performed on 489 patients. Most pacemakers were dual-chamber (82%) or magnetic resonance imaging (MRI)-compatible systems (83%). EMI was not detected with both mobile phone positions. Interference with telemetry was demonstrated in 11.5% of patients. Almost all incidences of interference (98.2%) occurred during incoming calls. Single-chamber pacemakers, non-MRI-compatible systems, older pulse generators, older leads, and unipolar settings were significantly related to a higher incidence of interference with interrogation telemetry. Conclusions: The risk of EMI between modern smartphones with 5G networks and pacemakers is low. Nevertheless, interference with the interrogation telemetry may still occur.

Introduction: The sheathless transradial (TR) technique is a novel approach that may offer potential benefits over the conventional TR approach. We aim to comprehensively investigate the safety and efficacy of sheathless versus conventional TR percutaneous coronary interventions (PCIs). Methods: We conducted comprehensive searches across PubMed, CENTRAL, Web of Science (WOS), Scopus, and EMBASE until July 2023. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, along with a 95% confidence interval (CI). PROSPERO ID: CRD42023443834. Results: We included 11 studies with 15,392 patients. The radial artery spasm (RAS) (RR: 0.26, 95% CI: [0.09, 0.77], p=0.02) and cross-over to the femoral site (RR: 0.28, 95% CI: [0.10, 0.81], p=0.02) were significantly lower in the sheathless group. However, radial artery occlusion (RAO) (RR: 2.84, 95% CI: [1.78, 4.54], p<0.0001) and success rate (RR: 1.011, 95% CI: [1.004, 1.019], p=0.002) were significantly higher in the sheathless group. Also, we did not find a significant difference between both groups in all-cause mortality (RR: 0.41, 95% CI: [0.16, 1.04], p=0.06). Conclusion: The sheathless TR approach showed lower rates of RAS and femoral conversion. Sheathless has a higher success rate; however, it also increased RAO. Thus, more trials are needed to confirm this technique’s long-term outcomes and complications.

The DynamX Bioadaptor is a novel implant with uncaging elements that disengage after polymer resorption and permits restoration of vessel function, thereby potentially reducing late adverse cardiac events. We evaluated the safety and efficacy of this novel implant with imaging follow-up at 6-months, the time point when the bioadaptor starts to uncage. This prospective study enrolled 44 patients with up to two de novo lesions at seven centers in New Zealand treated with the DynamX Bioadaptor. Follow-up was planned out to 12-months. The primary safety and efficacy endpoints were 6-month target lesion failure (TLF) and late lumen loss. Patients presented with non-ST elevation myocardial infarction in 49%. Lesions (n = 45) were 16.0 ± 6.7 mm long, and 2.81 ± 0.41 mm in diameter. Device and procedure success were 100%, and acute lumen gain was 1.93 ± 0.35 mm. At 6-months, median in-device late lumen loss was 0.09 mm (IQR:0.05–0.16). Measured by intravascular ultrasound, the vessel, lumen, and device area remained constant. By optical coherence tomography, 96.4% ± 5.9% of struts per lesion were covered. Out to 12-months, no TLF and no definite or probable device thrombosis were reported. In conclusion, this study provides evidence of the safety and performance of the DynamX Bioadaptor with excellent 12-month clinical and 6-month imaging outcomes comparable to best-in-class drug-eluting stents (DES). Trial Registration: ClinicalTrials.gov identifier: NCT03634020, NCT05464147, NCT04562805, and NCT04192747.

Background: Percutaneous (PC) access has become the first-line strategy for transfemoral (TF) transcatheter aortic valve replacement (TAVR), but surgical cutdown (SC) may be required in selected and usually challenging cases. We aimed to compare the efficacy and safety of SC versus echo-guided PC approach in TF TAVR. Methods: Between November 2019 and December 2020, all patients undergoing TF TAVR were included in a prospective study. The choice of PC or SC strategy was left at operators’ discretion, according to predictable access site difficulties. The primary endpoint included all vascular complications (VCs) and all bleeding at 1-month follow-up according to Valve Academic Research Consortium-2 criteria. Results: Among 225 patients, 166 (73.8%) and 59 (26.2%) underwent PC or SC approach, respectively. Median age was 82 years, EuroSCORE 2 was higher (p=0.02), and peripheral arterial disease (p<0.001) was more common in the SC group. Femoral access was successful in 100% in the SC group vs 97.6% in the PC group (p=0.2). The primary endpoint was reached in 32 patients (14.2%), 5 (8.4%) in the SC group and 27 (16.2%) in the PC group (p=0.1) with low incidence of major VC in both groups (1.7% vs 3% in the SC and PC groups respectively, p=0.6). Conclusion: Despite a higher risk profile of patients in the SC group, SC and PC approaches appear safe and effective in TF TAVR, with a high success rate. SC may be considered when vascular access is anticipated as complex, but this strategy might be confirmed in a randomized study. Trial Registration: ClinicalTrials.gov identifier: NCT03865043

Objective: To investigate the effects of a drug-coated balloon (DCB) on inflammatory cytokines in patients with coronary artery calcification (CAC) after interventional therapy. Methods: This study included 58 patients with coronary heart disease who underwent coronary angiography (CAG) from October 2020 to September 2021. Patients were divided into CAC and non-CAC groups, and a DCB was used to intervene in the target lesions. Ten-milliliter preoperative and postoperative blood samples were drawn from the coronary lesions in both groups to detect the expression of serum interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and intercellular adhesion molecule-1 (ICAM-1). All patients were subjected to a 6-month follow-up to observe the incidence of major adverse cardiac events (MACEs). Results: No significant differences in baseline clinical data were found between the groups. Serum IL-6, TNF-α, and ICAM-1 expressions in coronary blood samples immediately before DCB were not significantly different from those after DCB in all patients. After DCB, serum TNF-α expression in the CAC group was significantly lower than that in the non-CAC group (p<0.05). In contrast, no significant difference in serum IL-6 and ICAM-1 expression was found between the groups. During the 6-month follow-up, no significant difference in the incidence of MACE was found between both groups. Conclusions: DCB reduced the expression of inflammatory cytokine TNF-α in CAC, which may be one of the key mechanisms underlying the treatment of CAC by DCB.

Background: Vascular complications after coronary angiography (CAG) or percutaneous coronary intervention (PCI) are a major concern for revascularization therapies. In this study, we investigated whether the application of a chitosan-based hemostatic pad (HP) could ameliorate vascular complications after CAG or PCI procedures. Methods: We retrospectively analyzed patients undergoing CAG or PCI in our cardiovascular center from January 2019 to December 2021. The incidence of total vascular complications including errhysis, large hematoma, pseudoaneurysm, radial artery occlusion (RAO), blister, and pain was recorded. Subgroup analyses of patients with a history of hypertension, patients with uncontrolled hypertension, and patients with controlled hypertension were performed. Results: Our results demonstrated that the application of chitosan-based HP had no effect on vascular complications after CAG or PCI procedures (odds ratio [OR]: 1.03 (0.84–1.26), p=0.80). Nevertheless, chitosan-based HP treatment markedly decreased the incidence of vascular complications in uncontrolled hypertensive patients (OR: 0.32 (0.11–0.95), p=0.04), but not in hypertensive patients with controlled blood pressure (BP) (OR: 1.09 (0.88–1.35), p=0.42). Conclusions: Chitosan-based HP treatment could reduce the incidence of vascular complications in patients with uncontrolled hypertension. Nonetheless, applying chitosan-based HP treatment after CAG or PCI procedures is not recommendable for controlled hypertensive patients.

Heart failure (HF) represents a critical stage of cardiac disease, associated with high morbidity and mortality. Cardiac resynchronization therapy (CRT) has become a pivotal treatment for HF patients with prolonged QRS duration. This therapy employs a biventricular pacing system to correct cardiac electromechanical dyssynchrony, thereby improving cardiac function, symptoms, and prognosis. Numerous clinical trials have consistently highlighted the benefits of CRT in this subgroup, leading to its unanimous recommendation in clinical practice guidelines. However, a significant proportion of patients do not achieve an adequate therapeutic response, despite adherence to these guidelines. As CRT treats patients by correcting cardiac electromechanical dyssynchrony, assessing electrical and mechanical dyssynchrony is crucial in candidate selection. This review explores the evidence, recent clinical practice guidelines, and insight into electrical and mechanical dyssynchrony to optimize CRT candidate selection in HF patients with prolonged QRS duration.

Objective. We aimed to examine the benefits of catheter ablation on left heart structure and function in patients with persistent atrial fibrillation (AF) accompanied by heart failure (HF) with preserved ejection fraction (HFpEF), in comparison with the benefits in patients with AF accompanied by HF with reduced ejection fraction (HFrEF) or patients with no HF. Methods. A total of 399 patients with nonvalvular persistent AF who underwent catheter ablation from 2015 to 2021 were retrospectively included sixty-seven patients with recurrence of AF within 1 year were excluded, as well as 53 patients who failed to be followed up at (12 ± 1) months after the procedure. Finally, 279 patients who fulfilled the criteria were included and divided into these groups: the HFpEF group (left ventricular ejection fraction (LVEF) ≥50% and N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) ≥125 pg/ml or E/e′ ≥15, n = 116), HFrEF group (LVEF <50%, n = 48), and no HF group (NT-proBNP <125 pg/ml, n = 115). The endpoints were changes in image-based functional status from baseline to 1 year, including echocardiogram and speckle-tracking echocardiography. Results. The left atrial structure of patients with HFpEF decreased significantly 1 year after catheter ablation (left atrial anteroposterior dimension: 41.48 ± 4.53 mm vs. 38.64 ± 4.40; left atrial mediolateral dimension: 41.99 ± 5.52 vs. 38.24 ± 4.63 mm; left atrial superoinferior dimension: 61.36 ± 6.73 vs. 56.44 ± 6.97 mm). The left atrial and left ventricular volumes were significantly reduced and the ejection fraction was increased in all three groups, with HFrEF patients benefiting more. In the speckle-tracking echocardiography indexes, significant improvements were observed in left atrial strain (16.83 ± 6.91 vs. 28.05 ± 9.92), left atrial storage function (0.97 ± 0.38 vs. 1.49 ± 0.58), and left atrial pump function (−1.15 ± 0.55 vs. −1.68 ± 0.75) among HFpEF patients after 1 year, with no changes in left atrial conduit function (−1.55 ± 0.62 vs. −1.50 ± 0.54). In addition to the above improvements in left atrial structure and function, there was no significant improvement in left ventricular diastolic function in patients with HFpEF (E/e′, 14.11 ± 5.52 vs. 14.30 ± 7.25, P = 0.85). Conclusion. Catheter ablation is beneficial in restoring sinus rhythm in patients with persistent AF with coexisting HFpEF, significantly decreasing the left atrial size, improving left atrial storage function and left atrial pump function, and increasing left atrial and left ventricular ejection fraction.

Objective. To compare the relative effectiveness of different anti-Rx devices in terms of radiation dose absorbed by operators during percutaneous coronary procedures (diagnostic or interventional). Background. Direct comparisons among different adjunctive anti-Rx devices during percutaneous coronary procedures to reduce operator radiation exposure are lacking. Methods. We retrospectively analyzed the last 200 percutaneous procedures performed by a single operator according to the use of adjunctive protective devices (group 1) or standard anti-Rx setting (group 2). Subsequently, the procedures in group 1 have been divided according to the protective device utilized (homemade pelvic drape with under-table curtain, or RADPAD drape, or the STAR System device, or the Rampart shield). The primary endpoint was the operator radiation dose at the thorax. Results. Groups 1 and 2 did not show significant differences in terms of anthropometric data or cardiovascular risk factors. The use of adjunctive anti-Rx devices was associated with a significant reduction in operator radiation exposure compared to standard radioprotection (12.8 μSv [7–21] and 22.6 μSv [11–36], respectively; p<0.0001). Globally, the anti-Rx devices utilized were associated with a reduced operator radiation exposure (11.7 μSv [2–19] for homemade drapes, 13.5 μSv [9–29] for RADPAD drape, 15 μSv [11–30] for STAR Board System, and 8 μSv [5–19] for Rampart; p<0.0001) with the homemade drapes and the Rampart system showing a lower operator exposure. Conclusions. The use of anti-Rx devices during percutaneous coronary procedures is associated with a significant lower operator radiation exposure with the greater effect obtained with pelvic drapes and the Rampart system.

Background. Chronic total occlusion (CTO) plaque modification (CTO-PM) is often used for unsuccessful CTO interventions. Methods. A multicenter, prospective study included consecutive patients with failed CTO recanalization. At the end of the failed procedure, patients received either a conventional (CB) or drug-coated balloon (DCB) for CTO-PM at the operator’s discretion and underwent a new attempt of CTO recanalization ∼3 months later. Results. A total of 55 patients were enrolled (DCB: 22; CB: 33), with a median age of 66 years. The median J-score was 3, and CCS angina classes III–IV were present in 45% of the patients. After the first CTO-PCI attempt, no in-hospital cardiac deaths were registered. The overall rate of in-hospital myocardial infarction was 3.6%, without significant differences between the DCB and CB groups (4.5% after DCB vs 3.0% after CB, p=0.999). The success rate of the second CTO-PCI attempt was 86.8%, with a periprocedural complication rate of 5.7% and with an overall rate of in-hospital complications of 24.5%, without significant differences between the 2 groups (13.6% in the DCB group vs 32.2% in the CB group, p=0.195). Compared with CB, in the DCB group, the second CTO-PCI required a shorter median fluoroscopy time (33 vs 60 min, p<0.001), a lower contrast volume (170 vs 321 cc, p<0.001), and a lower radiation dose (1.7 vs 3.3 Gy, p<0.001). At 1-year follow-up, outcomes were comparable between the 2 strategies, target vessel failure occurred in 5.7% and major adverse cardiovascular events in 18.2% (13.6% in the DCB group vs 21.2% in the CB group, p=0.494). Conclusions. PM after CTO recanalization failure is safe and warrants high success rates when a second attempt is performed. A DCB strategy for CTO-PM does not seem to ensure higher success or better clinical outcomes, but its use was associated with simpler staged procedures. This trial is registered with NCT05158686.