Continuation versus Interruption of Oral Anticoagulation during TAVI.

BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

In-vitro validation of coronary physiology assessment with 5 French guiding catheters.

BACKGROUND: The trans-radial approach for cardiac catheterization led to an increasing adoption of 5 French (F) catheters. We aim to evaluate reliability and reproducibility of coronary physiology assessment performed with 5F guiding catheter (GC). METHODS: Physiological measurements were performed in a coronary flow simulator, which provides two pulsatile flows, the baseline and hyperaemic flows. Two screws, positioned proximally and distally to the distal sensor of a pressure-temperature guidewire, were used to determine various combinations of stenoses and distal obstructions, simulating different pathophysiological conditions. For each setting, 5 measurements of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) were performed with 6F and 5F GCs. RESULTS: A total amount of 190 measurements were performed, 95 with 6F GC and 95 with 5F GC. Minimal differences between 6F and 5F GCs were detected for FFR [0.91 (IQR: 0.87-0.94) and 0.87 (IQR: 0.82-0.92) respectively, p < 0.001] and IMR (16.5 ± 8.8 and 15.4 ± 8.3 respectively, p = 0.001). Mean CFR was comparable between 6F and 5F GCs (3.6 ± 1.1 and 3.5 ± 0.7 respectively, p = 0.38). Misclassification rates were 1.0 %, 1.0 % and 0 % for FFR, CFR and IMR, respectively. According to Passing-Bablok analysis, an excellent agreement between 6F and 5F GCs was demonstrated for FFR and IMR, and a modest agreement for CFR. All measurements with 5F GC showed high reproducibility. CONCLUSIONS: In our in-vitro model, a complete physiological assessment including FFR, CFR and IMR resulted substantially comparable between 6F and 5F GCs. Further in-vivo analysis is required to support these findings.

Prevalence of Collateral Typology in Coronary Chronic Total Occlusion and Its Impact on Percutaneous Intervention Performance.

The presence of collateral channels providing distal blood supply is a distinctive characteristic of chronic total occlusion (CTO) lesions. However, data about the distinct baseline and procedural characteristics of each collateral subset are scarce. Accordingly, we sought to explore the procedural aspects specific for each collateral typology (ipsilateral collaterals [ICs], contralateral collaterals [CCs] or mixed) in CTO-percutaneous coronary intervention (PCI). A retrospective analysis of our CTO-PCI registry was performed to investigate the prevalence, procedural characteristics, and outcomes specific for each CTO-PCI subset, defined according to the inter-arterial connection anatomy. A total of 209 cases were included. Of the included cases, 45 (22%) and 92 (44%) patients displayed solely IC or CC, respectively, whereas in 72 (34%) both IC and CC were present (mixed). The procedural success rate was high (91.1%) and comparable among the different groups, despite greater lesion complexity in the CC group. The most frequent target vessel was the left circumflex in the IC group (51% of cases) and the right coronary artery in the CC (63%) and mixed (57%) groups. Among the IC cases, 42% showed a poor collateral connection function (2% and 10% for the CC and mixed group, respectively), and 46% showed a suboptimal collateral recipient artery filling (21% and 20% for the CC and mixed group, respectively). Most of the IC cases were performed using a single access (96%). In conclusion, the success and complication rates were comparable among the collateral typology groups, irrespective of the differences in the baseline and procedural characteristics. Phenotyping CTO as hereby proposed might be helpful for targeted procedural considerations.

Minimalistic Hybrid Approach for the Percutaneous Treatment of Coronary Chronic Total Occlusions: Midterm Follow-Up of an International Multicenter Cohort.

The minimalistic hybrid approach (MHA) is a recently proposed algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI), reducing the overall invasiveness of the procedure without impacting the acute results. However, data on midterm results are lacking. This study aimed to evaluate the midterm clinical outcomes of a multicenter international cohort of CTO PCI treated according to the MHA. Data from a consecutive series of patients with a CTO who underwent PCI according to the MHA between February 2019 and March 2022 were prospectively collected in 3 European centers and retrospectively analyzed. The main outcome was the first occurrence of a major adverse cardiac event (MACE), defined as a composite outcome of all-cause death, any myocardial infarction, and target vessel revascularization, at the last follow-up available. A total of 212 patients were included. The majority of the patients were symptomatic for angina (Canadian Cardiovascular Society class 2 or 3: 63.7%) at the time of the index procedure. The mean Japanese-CTO and CASTLE scores were 2.1 ± 1.2 and 2.0 ± 1.3, respectively. Technical success (CTO open with optimal flow) was achieved in 198 patients (93.9%) and procedural success (technical success without in-hospital MACEs) in 195 (91.9%). At the last follow-up available (median 677 days), the cumulative incidence rate of MACEs was 11.5%; in particular, all-cause death was 7.4%, any myocardial infarction was 4.3%, and unplanned target vessel revascularization was 6.5%. In conclusion, the midterm results of the MHA seem to be in line with contemporary results of other CTO PCI algorithms, thus potentially validating the MHA as a valuable alternative, provided that interventionalists are already expert CTO operators and accustomed to the definitions and peculiarities of MHA.

Alternative (Transulnar or Distal Radial) Arterial Access for Chronic Total Occlusion Percutaneous Coronary Intervention (Subanalysis from the Minimalistic Hybrid Approach Algorithm Registry).

The transradial approach (TRA) has become the primary choice for percutaneous coronary intervention (PCI); however, it may not be always feasible because of clinical and/or technical challenges. Alternative forearm accesses, such as transulnar approach (TUA) and distal radial approach (dTRA) may allow maintaining a wrist approach for the procedure, avoiding the femoral artery. This issue is particularly relevant in patients who underwent multiple revascularizations, such as those with chronic total occlusion (CTO) lesions. This study aimed to evaluate whether the use of TUA and/or dTRA is comparable with TRA in CTO PCI using a minimalistic hybrid approach algorithm, which limits the number of accesses used to minimize vascular access complications. Patients with CTO PCI treated solely through a fully alternative approach (TUA and/or dTRA) were compared with those treated solely through a standard TRA approach. The primary efficacy end point was procedural success, whereas the primary safety end point was the composite of major adverse cardiac and cerebral events and vascular complications. Of 201 CTO PCIs attempted, 154 procedures were considered for analysis (standard, n = 104, alternative, n = 50). Alternative and standard groups demonstrated comparable rates of both procedural success (92% vs 94.2%, p = 0.70) and primary safety end point (4.8% vs 6.0%, p = 0.70). Of interest, 7 French guiding catheters were more frequently used in the alternative group (44% vs 26%, p = 0.028). In conclusion, CTO PCI after minimalistic hybrid approach by way of alternative forearm vascular accesses (dTRA and/or TUA) is feasible and safe to perform, compared with CTO PCI by way of standard TRA.

The Place of Transaxillary Access in Transcatheter Aortic Valve Implantation (TAVI) Compared to Alternative Routes-A Systematic Review Article.

Background: Transfemoral transcatheter aortic valve implantation (TAVI) has proven non-inferior or superior against surgical aortic valve replacement (SAVR) for patients at high, intermediate or low surgical risk. However, transfemoral access is not always feasible in patients with severely atherosclerotic or tortuous iliofemoral arteries. For these cases, alternative access techniques have been developed, such as transcarotid, transcaval, direct aortic or transaxillary access. In recent years, growing preference towards the transaxillary access has emerged. To provide a summary of data available on transaxillary TAVI and compare this approach to other alternative access techniques. Methods: A literature search was performed in PubMed by two independent reviewers. Studies reporting the outcome of at least 10 patients who underwent transaxillary TAVI, either in case series or in comparative studies, were included in this review. Articles not reporting outcomes according to the Valve Academic Research Consortium (VARC) 1-3 definitions were excluded. Results: In total 193 records were found of which 18 were withheld for inclusion in this review. This review reports on the combined data of the 1519 patients who underwent transaxillary TAVI. Procedural success was achieved in 1203 (92.2%) of 1305 cases. Life-threatening, major, and minor bleeding occurred respectively in 4.5% (n = 50 in 1112 cases), 12.9% (n = 143 in 1112 cases) and 8.8% (n = 86 in 978 cases). Major and minor vascular complications were reported in respectively 6.6% (n = 83 in 1256 cases) and 10.0% (n = 105 in 1048 cases) of patients. 30-day mortality was 5.2% (n = 76 out of 1457 cases). At one year follow-up, the mortality rate was 1% (n = 184 out of 1082 cases). Similar 30-day and 1-year mortality is observed in studies that compare with transaxillary, transfemoral or other alternative access techniques (p > 0.05). Conclusions: A wide application of transaxillary access as an alternative approach for TAVI has emerged. This technique has an excellent procedural success rate up to 92.0%, with low procedural complication rates. Clinical outcome of transaxillary TAVI is comparable to the other alternative TAVI approaches. However, these conclusions are solely based on observational data.

Intracoronary Lithotripsy in Calcified Coronary Lesions: A Multicenter Observational Study.

OBJECTIVES: The aim of this study was to evaluate the feasibility, effectiveness, and safety of coronary intravascular lithotripsy (IVL; Shockwave Medical) in the treatment of severe coronary artery calcification (CAC) in a real-world setting. BACKGROUND: Severe CAC can be an arduous obstacle in interventional cardiology, often leading to suboptimal results of percutaneous coronary interventions (PCI). Coronary IVL is a novel technique that modulates severe CAC, thereby facilitating stent implantation. METHODS AND RESULTS: In this multicenter observational study, data from 134 IVL procedures in 5 Belgian hospitals were prospectively obtained. Successful delivery of the IVL catheter was achieved in all cases but 1 (99.3%). The primary endpoint was final overall procedural success, which was obtained in 88.1% of cases, an aggregate of 92.6% in de novo lesions and 77.5% in stent underexpansion or in-stent restenosis (ISR). IVL therapy effect was considered successful by the operators in 94% of cases, with 68.7% achieving optimal and 25.3% achieving suboptimal results. The 1-month major adverse cardiovascular event rate was 3%, including 2 cardiovascular deaths (1 in-stent thrombosis and 1 coronary artery perforation). CONCLUSIONS: This real-world experience suggests that Shockwave IVL is a feasible, effective, and safe technique for the treatment of heavily calcified coronary lesions.

Endothelial Avulsion of the Septal Branch During Retrograde Chronic Total Occlusion Intervention.

Percutaneous revascularization of chronic total occlusions (CTOs) is known for the high technical complexity. Considering the constant increase in CTO procedures, subsequent peri-procedural complications will rise too, thus they need to be promptly recognized and evaluated for their potential risk of clinical sequelae. We report the case of a newly described complication during trans-septal retrograde CTO intervention: a septal collateral artery dissection due to endothelial avulsion.