Comparison of angiographic result and long-term outcome in patients with in-stent restenosis treated with cutting balloon or with scoring balloon angioplasty.

BACKGROUND: Lesion preparation with a cutting (CB) or scoring balloon (SB) is often used in patients with in-stent restenosis (ISR). However, there are no comparative studies. METHODS: We analyzed 81 patients (CB group: n = 38; SB group: n = 43) who had a calcified ISR from November 2019 to September 2021. The primary endpoint was strategy success (less than 20% residual stenosis); the secondary endpoints were major adverse cardiovascular events during the 1-year follow-up. Quantitative coronary angiography was performed to evaluate the strategy success. RESULTS: The patients in the CB group were more likely to have a severe calcified ISR (P = .001) and multiple stent layers (P = .001). A total of 64 patients (79.0%) reached the primary endpoint. Residual stenosis greater than 20% was more common in the CB group (39.5% vs 4.7%; P = .001). In the multivariate analysis, an effect of the intervention group on the achievement of the primary endpoint could be excluded (estimate 1.06; standard error 1.07; P = .322). The time interval of stent implantation prior to CB/SB (P = .007) and severe calcified ISR (P = .009) had a negative impact on reaching the primary endpoint. During the follow-up, there were no differences in rates of cardiac death (CB 2.5% vs. SB 1.2%; P = .598), acute myocardial infarction (CB 0% vs. SB 4.9%; P = .119), and target lesion failure (CB 3.7% vs SB 12.3%; P = .074). CONCLUSIONS: In our cohort, multivariate analysis showed that lesion preparation with CB or SB must be considered equivalent in terms of angiographic results. Factors like severe calcified ISR and the time interval of prior stent implantation negatively influenced the angiographic outcome.

Impella for the Management of Ventricular Septal Defect Complicating Acute Myocardial Infarction: A European Multicenter Registry.

Ventricular septal defect (VSD) is a rare but severe complication of myocardial infarction (MI). Temporary mechanical circulatory support (MCS) can be used as a bridge to VSD closure, heart transplantation, or ventricular assist device. We describe the use of Impella device in this context based on a multicenter European retrospective registry (17 centers responded). Twenty-eight post-MI VSD patients were included (Impella device were 2.5 for 1 patient, CP for 20, 5.0 for 5, and unknown for 2). All patients were in cardiogenic shock with multiple organ failure (SAPS II 41 [interquantile range {IQR} = 27-53], lactate 4.0 ± 3.5 mmol/L) and catecholamine support (dobutamine 55% and norepinephrine 96%). Additional temporary MCS was used in 14 patients (50%), mainly extracorporeal life support (ECLS) (n = 9, 32%). Severe bleedings were frequent (50%). In-hospital and 1 year mortalities were 75%. Ventricular septal defect management was surgical for 36% of patients, percutaneous for 21%, and conservative for 43%. Only surgically managed patients survived (70% in-hospital survival). Type and combination of temporary MCS used were not associated with mortality (Impella alone or in combination with intra-aortic balloon pump [IABP] or ECLS, p = 0.84). Impella use in patients with post-MI VSD is feasible but larger prospective registries are necessary to further elucidate potential benefits of left ventricular unloading in this setting.

Transcatheter edge-to-edge repair in mitral regurgitation: A comparison of device systems and recommendations for tailored device selection. A systematic review and meta-analysis.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive surgical risks. The traditionally used device, MitraClip, showed both safety and effectiveness in M-TEER. PASCAL is a newer device that has emerged as another feasible option to be used in this procedure. METHODS: We searched for observational studies that compared PASCAL to MitraClip devices in M-TEER. The electronic databases searched for relevant studies were PubMed/MEDLINE, Scopus, and Embase. The primary outcomes were technical success and the grade of MR at follow-up. Secondary outcomes included all-cause mortality, bleeding, device success and reintervention. RESULTS: Technical success (PASCAL: 96.5% vs MitraClip: 97.6%, p = 0.24) and MR ≤ 2 at 30-day follow-up (PASCAL: 89.4vs MitraClip 89.9%, p = 0.51) were comparable between both groups. Both devices showed similar outcomes including all-cause mortality (RR: 0.68 [0.34, 1.38]; P = 0.28), major bleeding (RR: 1.87 [0.68, 5.10]; P = 0.22) and reintervention (RR: 1.02 [0.33, 3.16]; P = 0.97). Device success was more frequent with PASCAL device (PASCAL: 86% vs MitraClip 68.5%; P = 0.44), however, the results did not reach statistical significance. CONCLUSION: Clinical outcomes of PASCAL were comparable to those of MitraClip with no significant difference in safety and effectiveness. The choice between MitraClip and PASCAL devices should be guided by various factors, including mitral valve anatomy, etiology of regurgitation, and device-specific characteristics.

Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).

Iatrogenic perforation of a pulmonary artery side branch-a case report.

BACKGROUND: The use of a pulmonary artery catheter (PAC) continues to be important for the diagnosis and therapeutic control of severe heart failure and in the diagnosis of pulmonary arterial hypertension. One of the most feared complications of this examination is perforation of a pulmonary artery with an estimated incidence of 0.031-0.05% and mortality rates of up to 70%. CASE SUMMARY: We report on an 80-year-old female patient who experienced a perforation of a pulmonary artery branch during the work-up of pulmonary arterial hypertension by PAC. Immediately after the perforation, haemodynamic shock developed rapidly, necessitating cardiopulmonary resuscitation. Occlusion of the pulmonary artery branch with a semicompliant balloon was applied immediately. After 40 min of occlusion, the bleeding persisted, and endovascular coil implantation was performed. Subsequently, the bleeding stopped, and the haemodynamics stabilized. After treatment, the patient was discharged home without any significant sequelae. DISCUSSION: Treatment options in pulmonary artery perforation are limited, especially if the patient is inoperable and if balloon occlusion fails. Based on our results, endovascular coil embolization can be considered a therapeutic option.