First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

A novel use of small ballons to reduce the risk of subintimal hematoma formation during recanalization of chronic total occlusion: two case reports.

BACKGROUND: Subintimal hematoma remains a major challenge associated with unnecessary technical complexity, failure of the antegrade approach or imperfection of revascularization in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). Some techniques and devices release the hematoma after its formation. Here, we describe a novel use of small ballons to prevent the hematoma formation during antegrade approach in two cases. CASE PRESENTATION: We report two cases of CTO-PCI in which balloon occlusion was successfully applied to prevent haematoma formation. The first case, a 72-year-old female with diabetes, was hospitalized because of unstable angina. Angiography showed right coronary artery (RCA) CTO, which initiated from the proximal part to the trifurcation at the distal part of the RCA. Considering the high likelihood and serious consequences of subintimal haematoma, a small balloon is employed to prevent subintimal hematoma formation. A balloon and microcatheter or double-lumen microcatheter are placed in the proximal coronary CTO lesion; then the balloon was dilated beside the catheter, most of the antegrade blood flow was sealed which reduced the likelihood of haematoma formation. The procedure was successfully completed without subintimal hematoma formation. The second case a 62-year-old male with unstable angina, was hospitalized for PCI. Angiography showed left anterior descending coronary artery CTO. Similar to case 1, we also used a small balloon to prevent hematoma formation. Both patients underwent PCI, which employed a small balloon to prevent hematoma formation and both procedures were successful without complications. CONCLUSION: In patients who underwent CTO-PCI, balloon occlusion offers an alternative for reducing the incidence of subintimal haematomas.

Perfusion Balloon Is Useful for Preventing Obstruction of Left Main Coronary Artery During Transcatheter Aortic Valve Implantation.

The incidence of acute coronary obstruction during transcatheter aortic valve implantation (TAVI) is low (< 1.0%); however, it is associated with high mortality. An 83-year-old female with a history of chest pain and syncope was diagnosed with severe aortic stenosis. Computed tomography showed severely calcified aortic leaflets with a low left coronary ostial height of 7.8 mm, which indicates a high risk of coronary obstruction. TAVI was performed using the right femoral artery approach under general anesthesia. To prevent coronary obstruction and minimize coronary flow obstruction, coronary protection of the left main tract (LMT) via the left radial artery was established with a perfusion balloon. We crossed a 23 mm Sapien 3 transcatheter heart valve and settled it at an appropriate position on the aortic valve. After inflation of the perfusion balloon at the LMT, we started rapid ventricular pacing, and deployed the Sapien 3 using the KBI technique. Hemodynamics were stable and aortography showed excellent coronary flow with no stenosis of the LMT ostium. This strategy may serve as a useful method to prevent coronary obstruction and minimize coronary ischemia.

Active Versus Conventional Side Branch Protection Strategy for Coronary Bifurcation Lesions.

The side branch (SB) provisional stenting strategy is currently the recommended approach for most coronary bifurcation lesions. However, this strategy may result in SB deterioration, which is associated with an increased incidence of periprocedural myocardial infarction (PMI) and may adversely affect the long-term prognosis. Various techniques for SB protection (SB-P) have been developed to reduce SB occlusion and improve the clinical prognosis. This meta-analysis was performed to compare the outcomes of an active SB-P strategy of jailed balloon technique, balloon-stent kissing technique, and jailed Corsair technique versus the conventional SB-P strategy based on jailed wire technique.This meta-analysis included 5 studies (4 randomized and 1 observational) involving a total of 1,174 patients in whom the active and conventional SB-P strategies were compared. Fixed- and random-effects models were used to calculate summary risk ratios (RRs).The risk of SB occlusion was significantly lower in active SB-P strategy [RR 0.47, 95% confidence interval (CI) 0.30-0.73 in fixed-effect model; RR 0.52, 95% CI 0.31-0.87 in random-effect model]. The risk of PMI was similar between the two strategies (RR 0.63, 95% CI 0.30-1.33 in fixed-effect model; RR 0.71, 95%CI 0.20-2.48 in random-effect model). The rate of long-term major adverse cardiovascular events was similar between the groups (RR 0.48, 95% CI 0.15-1.48 in fixed-effect model; RR 0.49, 95% CI 0.16-1.52 in random-effect model).The active SB-P strategy in coronary bifurcation lesions is associated with reduced SB deterioration, but it does not decrease PMI or improve the long-term prognosis.

Risk and Mitigation of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

Acute coronary artery occlusion is a rare but devastating complication of transcatheter aortic valve replacement. Coronary obstruction is angiographic evidence of a new-partial or complete-obstruction of a coronary artery. Key factors identifying patients at risk are aortic root anatomy, type of aortic valve, and type of transcatheter heart valve. Techniques to prevent coronary obstruction include intentional leaflet laceration. If acute coronary obstruction does occur, bailout stenting can be challenging and conversion to emergent open heart surgery may be required, both of which are associated with high morbidity and mortality.

Prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the Hamburg BASILICA experience.

OBJECTIVES: This study aimed to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (BASILICA) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (TAVI)-induced coronary obstruction. METHODS: Between October 2019 and January 2021, a total of 15 consecutive patients (age 81.0 [78.1, 84.4] years; 53.3% female; EuroSCORE II 10.6 [6.3, 14.8] %) underwent BASILICA procedure prior to TAVI at our institution. Indications for TAVI were degeneration of stented (n = 12, 80.0%) or stentless (n = 1, 6.7%) bioprosthetic aortic valves, or calcific stenosis of native aortic valves (n = 2, 13.3%), respectively. Individual risk of TAVI-induced coronary obstruction was assessed by pre-procedural computed tomography analysis. Procedural and 30-day outcomes were documented in accordance with Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: BASILICA was attempted for single left coronary cusp in 12 patients (80.0%), for single right coronary cusp in 2 patients (13.3%), and for both cusps in 1 patient (6.7%), respectively. The procedure was feasible in 13 patients (86.7%) resulting in effective prevention of coronary obstruction, whilst TAVI was performed without prior successful bioprosthetic leaflet laceration in two patients (13.3%). In one of these patients (6.7%), additional chimney stenting immediately after TAVI was performed. No all-cause deaths or strokes were documented after 30 days. CONCLUSION: The BASILICA technique appears to be a feasible, safe and effective concept to avoid iatrogenic coronary artery obstruction during TAVI in both native and bioprosthetic valves of patients at high or prohibitive risk. ClinicalTrials.gov Identifier: NCT04227002 (Hamburg AoRtic Valve cOhoRt).

Ethnic variance on long term clinical outcomes of concomitant use of proton pump inhibitors and clopidogrel in patients with stent implantation: A PRISMA-complaint systematic review with meta-analysis.

BACKGROUND: Pharmacokinetic and pharmacodynamic study showed a lower clopidogrel response when coprescribed with proton pump inhibitors (PPIs). Despite this, PPIs is necessary for patients treated with long term dual antiplatelet therapy (DAPT). Ethnic variance also played a different effect on clopidogrel response. Our study evaluated the effect of concomitant use of DAPT and PPIs and assessed whether ethnic variance exert different effect on clinical outcomes. METHODS: We carefully searched EMBASE, PubMed/Medline databases, and the Cochrane library in April 2019. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) and individual endpoints reported. We also focused on bleeding events. Studies were excluded if the follow-up were <12 months and patients were not treated with clopidogrel after stent implantation. RESULTS: A total of 18 studies were included in the systematic review (involving 79,670 patients). No randomized controlled trials (RCTs) were included. PPIs comedication were associated with increased MACCE (odds ratio [OR] = 1.38; 95% confidence interval [CI] = 1.28-1.49) while not associated with decreased bleeding risks, such as gastrointestinal bleeding (OR = 1.05; 95% CI = 0.53-2.11). PPIs comedication were associated with increased risk for all endpoints among Caucasian population while not with increased risk for MACE (OR = 1.20; 95% CI = 0.99-1.39), all-cause death (OR = 1.24; 95% CI = 0.74-2.06), cardiac-death (OR = 1.29; 95% CI = 0.64-2.57) among Asian population. CONCLUSION: PPIs comedication were associated with adverse clinical outcomes, and ethnic variance may exert different effect on clinical outcomes. Subgroup analysis indicated that concomitant use of PPI might be suitable for Asian patients after stent implantation.

Recurrent coronary thrombotic events in a moderate case of COVID-19.

We describe the case of a healthy patient with moderate COVID-19 infection without thrombophilia nor coronary disease background who presented with a relapsing thrombotic occlusion of the right coronary artery despite normal oxygenation, adequate antiaggregation and prophylactic anticoagulation. Prophylactic anticoagulation recommendations in COVID-19 were inadequate for this patient. Further data are needed to propose full-dose therapeutic anticoagulation for patients with coronary thrombosis and COVID-19 infection. This could nevertheless be considered even in mild forms of COVID-19.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique in transcatheter aortic valve-in-valve procedures: a single-center initial experience.

AIM: To describe six cases using the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique to prevent coronary artery obstruction during transcatheter aortic valve-in-valve procedures. METHODS: All patients presented degeneration of a bovine pericardium bioprosthesis [four Trifecta (19, 21, 23, and 25 mm); two Mitroflow (25 and 27 mm)] resulting in severe aortic stenosis (n = 5) or severe aortic regurgitation (n = 1). Procedures were performed under fluoroscopic and echocardiography guidance, and the transfemoral access was used to deliver a self-expanding valve. Data are expressed as frequency or median (Q1-Q3). RESULTS: Age, EuroScore II, and Society of Thoracic Surgeons score were 81 years (75-83.2), 2.9% (2.6-10.7), and 2.7% (2.3-3.2), respectively. Median left and right coronary heights were 9.1 mm (6.2-10.3) and 12.4 mm (10-13.5), respectively, with a median virtual transcatheter heart valve-to-coronary distance of 2.9 mm on the left and 4.6 mm on the right side. Isolated left leaflet laceration was planned in four patients, and bileaflet in two. One unsuccessful right leaflet laceration was reported, corresponding to the first patient (success rate 87.5%). All other seven leaflets lacerations were successfully performed, with no intraprocedure complications. No coronary obstruction, in-hospital death, valve complication, cardiovascular event, or pacemaker implantation were reported. All patients are being followed in routine outpatient visits, and no adverse events were registered. CONCLUSION: The high procedural success and low complication rate reported in this initial experience, demonstrates that the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique can be a viable solution to prevent coronary obstruction in selected patients undergoing valve-in-valve procedures. Operator experience, periprocedural imaging and teamwork are essential to enable an accurate and successful procedure.

Aortic Root Replacement to Accommodate Future Valve-in-Valve Transcatheter Aortic Valve Replacement.

Coronary obstruction is a feared complication associated with valve-in-valve transcatheter aortic valve replacement (TAVR) that may prevent patients with high anatomical risk from being considered. Aortic root replacement at the time of the index TAVR allows higher coronary implantation and augmentation of transcatheter heart valve to coronary ostial distance. This approach permits future valve-in-valve TAVR and may be an important strategy in lifetime valve selection management, particularly in young patients.

Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial.

OBJECTIVES: The aim of this study was to determine whether an active side branch protection (SB-P) strategy is superior to the conventional strategy in reducing side branch (SB) occlusion in high-risk bifurcation treatment. BACKGROUND: Accurate prediction of SB occlusion after main vessel stenting followed by the use of specific strategies to prevent occlusion would be beneficial during bifurcation intervention. METHODS: Eligible patients who had a bifurcation lesions with high risk for occlusion as determined using the validated V-RESOLVE (Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention) score were randomized to an active SB-P strategy group (elective 2-stent strategy for large SBs and jailed balloon technique for small SBs) or a conventional strategy group (provisional stenting for large SBs and jailed wire technique for small SBs) in a 1:1 ratio stratified by SB vessel size. The primary endpoint of SB occlusion was defined as an angiography core laboratory-assessed decrease in TIMI (Thrombolysis In Myocardial Infarction) flow grade or absence of flow in the SB immediately after full apposition of the main vessel stent to the vessel wall. RESULTS: A total of 335 subjects at 16 sites were randomized to the SB-P group (n = 168) and conventional group (n = 167). Patients in the SB-P versus conventional strategy group had a significantly lower rate of SB occlusion (7.7% [13 of 168] vs. 18.0% [30 of 167]; risk difference: -9.1%; 95% confidence interval: -13.1% to -1.8%; p = 0.006), driven mainly by the difference in the small SB subgroup (jailed balloon technique vs. jailed wire technique: 8.1% vs. 18.5%; p = 0.01). CONCLUSIONS: An active SB-P strategy is superior to a conventional strategy in reducing SB occlusion when treating high-risk bifurcation lesions. (Conventional Versus Intentional Strategy in Patients With High Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [CIT-RESOLVE]; NCT02644434).

[Management of non-rhythmic complications of TAVI procedures]. / Gestion des complications non rythmologiques des procédures de TAVI.

Transcatheter aortic valve (TAVI) is the treatment of choice in patients with severe symptomatic aortic stenosis at high surgical risk. Recent data have also shown favorable results in patients considered to have an intermediate operative risk, which broadens the application of this new technology. Despite its success, the TAVI procedure has been associated with life-threatening complications. Advances in preoperative screening and patient selection have reduced the incidence of these complications. When these complications occur, early recognition and rapid management are essential. The purpose of this review is to describe non-rhythmic mechanical complications attributable to TAVI procedures with their predictive factors, how to prevent and manage them.