Journal of interventional cardiology最新文献

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 [25^th to 75^th 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: BE-ACTION Study ClinicalTrials.gov identifier: 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.