Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry.

BACKGROUND: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce. AIMS: We aimed to assess the clinical outcomes, including valve performance, of the S3UR. METHODS: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort. RESULTS: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group). CONCLUSIONS: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.

Efficacy and safety of post-closure technique using Perclose ProGlide/ProStyle device for large-bore mechanical circulatory support access sites.

PURPOSE: Mechanical circulatory support (MCS) using a venoarterial extracorporeal membrane oxygenation (VA-ECMO) device or a catheter-type heart pump (Impella) is critical for the rescue of patients with severe cardiogenic shock. However, these MCS devices require large-bore cannula access (14-Fr and larger) at the femoral artery or vein, which often requires surgical decannulation. METHODS: In this retrospective study, we evaluated post-closure method using a percutaneous suture-mediated vascular closure system, Perclose ProGlide/ProStyle (Abbott Vascular, Lake Bluff, IL, Perclose), as an alternative procedure for MCS decannulation. Closure of 83 Impella access sites and 68 VA-ECMO access sites performed using Perclose or surgical method between January 2018 and March 2023 were evaluated. RESULTS: MCS decannulation using Perclose was successfully completed in all access sites without surgical hemostasis. The procedure time of ProGlide was shorter than surgical decannulation for both Impella and VA-ECMO (13 min vs. 50 min; p < 0.001, 21 min vs. 65 min; p < 0.001, respectively). There were no significant differences in the 30-day survival rate and major adverse events by decannulation including arterial dissection requiring endovascular treatment, hemorrhage requiring a large amount of red blood cell transfusion, and access site infection. CONCLUSION: Our results suggest that the post-closure technique using the percutaneous suture-mediated closure system appears to be a safe and effective method for large-bore MCS decannulation.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial.

BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Commissural alignment in the Evolut TAVR procedure: conventional versus hat marker-guided shaft rotation methods.

Background: Coronary cannulation after TAVR is sometimes difficult due to an overlap between native and neo-commissures, especially in Evolut devices with a supra-annular position. The Evolut C-tab corresponds to a neo-commissure, and the hat marker is in a fixed position. Therefore, the orientation of the hat marker can be adjusted to minimise overlaps. Aims: We investigated whether the HAt marker-guided SHaft rotation method (HASH, stylised as the #rotation method) is effective in facilitating coronary artery access after transcatheter aortic valve replacement (TAVR) with an Evolut system. Methods: We retrospectively analysed 95 patients who underwent electrocardiogram-gated cardiac computed tomography after TAVR. In the #rotation method, the hat marker of the delivery catheter was adjusted to face the greater curvature of the descending thoracic aorta in the left anterior oblique view. Its orientation was maintained while the system passed through the aortic arch. Results: In total, 60 and 35 patients underwent TAVR with the #rotation and non-#rotation methods, respectively. A ±15° angle between the native and neo-commissures was more frequent in the #rotation group (p=0.001). Favourable angles and appropriate frame orientation for access to the left coronary artery were significantly more frequent in the #rotation group than in the non-#rotation group (p<0.001 and p=0.001). Although the #rotation method showed a higher rate of favourable angles and frames in the right coronary artery, statistically significant differences were not found. Conclusions: The #rotation method is useful for improving commissural post alignment in TAVR with Evolut devices, especially in the ostium of the left coronary artery.

Fibromuscular dysplasia of the brachial artery in patients with spontaneous coronary artery dissection: a case series and literature review.

Spontaneous coronary artery dissection (SCAD) is diagnosed in a very small percentage of patients with suspected acute coronary syndromes who undergo emergency coronary angiography. Although fibromuscular dysplasia (FMD) is known to coexist in patients with SCAD, the vascular sites of FMD and their frequency have not yet been clarified. We retrospectively reviewed the medical records of 16 patients who were diagnosed with and treated for SCAD at our hospital between 1 January 2011 and 31 January 2023. We have summarized their baseline and clinical characteristics and medical variables, including coronary and upper extremity angiography and in-hospital outcomes. One of our patients had concurrent cardiac tamponade requiring pericardial drainage, and another went into hemorrhage shock the following day from dissection of the gastric retroperitoneal artery. Characteristic angiographic features of partial or diffuse nonatherosclerotic stenosis were observed mainly in the distal parts of the coronary arteries or their branches. Notably, in six patients with SCAD who underwent upper extremity angiography, FMD of the brachial artery was revealed. For the first time, to our knowledge, we found a high prevalence of multifocal FMD of the brachial artery in patients with SCAD.

Incidence, Risk Factors, and Treatment of Venous Thromboembolism after a Serious Disaster: The Kumamoto Twin Earthquakes.

Objective: On April 16, 2016, earthquakes struck Kumamoto. In this report, the incidence and treatment of venous thromboembolism (VTE) in patients presenting to our hospital are summarized. Materials and Methods: We reviewed the details of 22 consecutive patients who were diagnosed with VTE at our hospital during the 2 weeks after the earthquakes. Results: Nineteen of the 22 patients stayed in their cars overnight after the earthquakes. Particularly, during the first 4 days, seven consecutive patients were hospitalized for pulmonary thromboembolism. All seven patients had sheltered in their cars after the earthquakes. The two patients transported on days 2.42 and 3.54 were the most severe cases. One patient was admitted after emergency initiation of venoarterial extracorporeal membrane oxygenation for treatment of hemodynamic collapse, whereas the other patient was admitted after resuscitation. By contrast, deep vein thrombosis (DVT) alone occurred within 5-9 days of the earthquakes. Bilateral DVT was the most common, which was followed by DVT on the right side only. Conclusion: The incidence of VTE might be higher after an earthquake, and an overnight stay in a car might be a risk factor for VTE. Stable patients based on the D-dimer concentration can be managed with nonwarfarin oral anticoagulants.

Impact of extracorporeal CPR with transcatheter heart pump support (ECPELLA) on improvement of short-term survival and neurological outcome in patients with refractory cardiac arrest - A single-site retrospective cohort study.

Aim: Extracorporeal cardiopulmonary resuscitation (E-CPR) using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a novel lifesaving method for refractory cardiac arrest. Although VA-ECMO preserves end-organ perfusion, it may affect left ventricular (LV) recovery due to increased LV load. An emerging treatment modality, ECPELLA, which combines VA-ECMO and a transcatheter heart pump, Impella, can simultaneously provide circulatory support and LV unloading. In this single-site cohort study, we assessed impact of ECPELLA support on clinical outcomes of refractory cardiac arrest patients. Method: We retrospectively reviewed 165 consecutive cardiac arrest patients, who underwent E-CPR by VA-ECMO with or without intra-aortic balloon pump (IABP) or ECPELLA from January 2012 to September 2021. We assessed 30-day survival rate, neurological outcome, hemodynamic data, and safety profiles including hemolysis, acute kidney injury, blood transfusion and embolic cerebral infarction. Results: Among 165 E-CPR patients, 35 patients were supported by ECPELLA, and 130 patients were supported by conventional VA-ECMO with or without IABP. Following propensity score matching of 30 ECPELLA and 30 VA-ECMO patients, the 30-day survival (ECPELLA: 53%, VA-ECMO: 20%, p < 0.01) and favorable neurological outcome determined by the Cerebral Performance Category score 1 or 2 (ECPELLA: 33%, VA-ECMO: 7%, p < 0.01) were significantly higher with ECPELLA. Patients receiving ECPELLA also showed significantly higher total mechanical circulatory support flow and lower arterial pulse pressure for the first 3 days (p < 0.01) of treatment. There were no statistical differences in safety profiles between treatment groups. Conclusion: ECPELLA may be associated with improved 30-day survival and neurological outcome in patients with refractory cardiac arrest.

Transfemoral Transcatheter Aortic Valve Implantation by Three-Dimensional Computed Tomography/Fluoroscopy Fusion Imaging Guidance in a Patient With Right-Sided Aortic Arch and Chronic Aortic Dissection.

Transcatheter aortic valve implantation (TAVI) represents the standard of care for relieving aortic stenosis in high-risk patients for surgery. The transfemoral approach is preferable with respect to invasiveness, but is often difficult in patients with complex vascular structures. Recently, the clinical application of advanced visualization and guidance technology with three-dimensional computed tomography (3D-CT) during TAVI has received considerable attention. Herein we report successful transfemoral TAVI in a patient with a right-sided aortic arch and chronic aortic dissection without vascular complications by 3D-CT/fluoroscopy fusion imaging guidance.

Comparison of left ventricular pacing performance among pre-shaped guidewires designed for transfemoral-approach transcatheter aortic valve implantation.

TAVI is an established therapy for patients with severe aortic stenosis. Rapid or control pacing is necessary for TAVI, and most centers are familiar with right ventricular (RV) pacing. Although there are several reports on the efficacy and safety of LV pacing, they are still few. In addition, LV pacing has not been studied for different LV guidewires. Our aim is to study the effectiveness of left ventricular (LV) pacing and the thresholds of LV guidewires in patients who underwent transcatheter aortic valve implantation (TAVI). We retrospectively analyzed 252 consecutive patients who underwent trans-femoral TAVI (TF-TAVI) with LV pacing in our institute between December 2017 and November 2020. We excluded 48 patients from the total cohort due to TAVI with RV pacing, and the remaining 204 patients were analyzed (52 males, mean age 85 ± 5 years). Among them, 202 patients (99.0%) had successful LV pacing. In the two patients with failed LV pacing, SAFARI2™ Small was used. The CONFIDA™ group (n = 34) showed a significantly lower threshold than the SAFARI2™ group (n = 163) (median 3.0 vs. 5.0 V; P = 1.1 × 10-7). LV pacing with Lunderquist® was successful in all patients (n = 7). LV pacing in TAVI was an effective and safe strategy. CONFIDA™ wire may be particularly well suited for LV pacing in TAVI.

Successful emergent transcatheter aortic valve implantation and left ventricular unloading by Impella in a patient with severe aortic stenosis who experienced cardiogenic shock after primary percutaneous coronary intervention for ST-elevation myocardial infarction: a case report.

BACKGROUND: Determining the treatment strategy for cardiogenic shock following ST-elevation myocardial infarction in a patient with severe aortic stenosis remains challenging and is a matter of debate. CASE SUMMARY: An 84-year-old man with chest pain was transferred to our institute and subsequently diagnosed with ST-elevation myocardial infarction and Killip class III heart failure. The patient was intubated, and urgent coronary angiography revealed severe tandem stenosis from the proximal to mid-left anterior descending coronary artery. We performed a primary percutaneous coronary intervention (PCI) and deployed drug-eluting stents from the left main trunk to mid-left anterior descending coronary artery. Although the procedure was successful, the patient went into cardiogenic shock a few hours later. Transthoracic echocardiography revealed low cardiac function and severe aortic stenosis. We decided to perform transcatheter aortic valve implantation using a self-expandable valve, followed by the insertion of a left ventricular assist device. The combination of procedures achieved haemodynamic stability. DISCUSSION: It is difficult to treat cardiogenic shock that develops in patients with severe aortic stenosis and ST-elevation myocardial infarction. This case report demonstrates that combined transcatheter aortic valve replacement using a self-expanding valve and left ventricular assist device placement can be safe and effective after a primary PCI.

A case of acute coronary syndrome caused by delayed coronary ischemia after transcatheter aortic valve implantation.

An 84-year-old female patient suffered from dyspnea due to severe aortic stenosis. Several comorbidities and her advanced age made her acceptable for transcatheter aortic valve implantation (TAVI). The TAVI procedure was performed via a femoral access and a 26-mm CoreValve prosthesis (Medtronic, Minneapolis, MN, USA) was implanted. The prosthesis was deployed at a high position because of short distance between the annulus base and coronary arteries. Aortic angiography indicated normal contrast flow into both coronary arteries. Six months later she was readmitted to our hospital because of acute coronary syndrome. Although selective intubation of coronary arteries could not be achieved because of high valve position, both coronary arteries seemed to be well contrasted. As a consequence, the second coronary angiography was undertaken because of recurring chest pains. The aortic root angiogram showed a decreased contrast flow into both coronary arteries. During the examination she deteriorated rapidly, developed cardiopulmonary arrest, and a percutaneous cardiopulmonary support and an intra-aortic balloon pump needed to be inserted. She was then transferred to the operating room for aortic valve replacement. This is the first case of delayed coronary ischemia after TAVI, necessitating the removal of an implanted CoreValve and its replacement with a new prosthetic valve. .

Impact of Killip classification on acute myocardial infarction: data from the SAIKUMA registry.

Therapeutic devices for acute myocardial infarction (AMI) have evolved dramatically in recent years. However, the impact of the Killip classification of AMI outcomes in patients undergoing aggressive percutaneous coronary intervention remains unclear. We performed a 10-year retrospective review of 2062 patients diagnosed with AMI, and divided the data into two 5-year intervals: 2005-2009 (n = 1071), and 2010-2014 (n = 991). No difference was observed in in-hospital mortality rate between the two periods (first period, 11.5% vs second period, 9.7%; P = 0.19). The incidence of stent thrombosis was not significantly different between the two periods, and very few thrombi occurred in patients who received second-generation drug-eluting stents (DES) (0.98%: 5/511). In-hospital mortality due to stent thrombosis was high in the full cohort (15%). During the second period, in-hospital mortality was lower in Killip class 4 patients, although the difference was not significant (59.1 vs 47.5%, P = 0.07). Multivariable logistic regression identified several factors that significantly affected in-hospital mortality, including age [odds ratio (OR) 1.07], left main trunk (OR 2.47), peak CPK value above 5000 IU/L (OR 3.18), and Killip class 4 (OR 15.63). We evaluated trends in in-hospital mortality among patients with AMI over a 10-year period. New DES and the frequent use of mechanical support in patients with hemodynamic compromise tended to improve in-hospital mortality, but the effect was not significant. Notably, Killip class 4 on admission was associated with an estimated 16-fold increased risk of in-hospital death.

An autopsy case of aortic root rupture with thin porcelain aorta during balloon-expandable transcatheter aortic valve implantation.

A 92-year-old woman was transferred to our institute due to drug-resistant heart failure from severe aortic stenosis. She seemed to be a candidate for transcatheter aortic valve implantation (TAVI) because of her frailty and porcelain aorta. There were no severe calcified nodules in the left-ventricular outflow tract area. Because three-dimensional computed tomography analysis showed that her basal annulus area was 419 mm2, a 26-mm SAPIEN XT (Edwards Lifesciences, Irvine, CA, USA) was selected for implantation. After deployment of the valve with 10% reduced volume, aortic root rupture occurred and her blood pressure fell due to acute cardiac tamponade. Emergent cardiac pericardial fenestration was done and drained blood was continuously returned to the circulation through percutaneous cardiopulmonary bypass. Despite strenuous efforts to save her life, she died 13 h after the event. An autopsy revealed a thin porcelain aorta and aortic root rupture with a fragile aortic wall. .

A lotus root-like appearance in both the left anterior descending and right coronary arteries.

A 60-year-old man was referred to our hospital because of dyspnea on exertion. He was diagnosed with heart failure due to an old myocardial infarction. Myocardial stress perfusion scintigraphy revealed inducible myocardial ischemia. Coronary angiography revealed hazy slit lesions in both the left anterior descending (LAD) and right coronary arteries (RCA). We first performed percutaneous coronary intervention (PCI) on the LAD lesion. Subsequently, we performed PCI for the RCA lesion using multiple imaging modalities. We observed a lotus root-like appearance in both the LAD and RCA, and PCI was successful for both vessels. We describe this rare case in detail.

Inadvertent consequences of percutaneous coronary intervention to treat unstable spontaneous coronary artery dissection.

We present two cases of spontaneous coronary artery dissection (SCAD), which were diagnosed and treated with emergent percutaneous coronary intervention (PCI). Patients with ongoing ischemia due to SCAD need emergent coronary revascularization with PCI or coronary artery bypass grafting. We discuss the difficulties of PCI to bail out unstable SCAD regardless of the modern techniques and modalities. Brief reviews of the literature with relevance are included. .

Inadvertent coronary endarterectomy during aspiration thrombectomy with a Thrombuster III GR catheter in a patient with acute coronary syndrome.

We describe a 41-year-old woman who presented with acute ST-segment elevation myocardial infarction. Emergent percutaneous intervention was performed with aspiration thrombectomy followed by coronary artery stenting. White material was extracted from the aspiration catheter. Reperfusion therapy after stenting was successful. After undergoing a cardiac rehabilitation program, she was discharged from hospital on day 10. Pathological examination revealed that the aspirated material consisted of normal vascular components including endothelial and smooth muscle cells. Aspiration thrombectomy is a commonly used procedure with a low complication rate. This case presents the previously unreported complication of coronary artery injury.

A case of acute coronary syndrome caused by a giant saddle thrombus at left main coronary artery bifurcation.

An 87-year-old woman who had metastatic lung cancer presented with intermittent chest discomfort. The emergent coronary angiogram showed a giant saddle thrombus at the left main coronary artery bifurcation without flow limitation. We performed thrombolysis with unfractionated heparin and warfarin under careful observation of the thrombus with a 320-row area detector computed tomography (ADCT). Ten days later, the second examination with ADCT revealed complete resolution of the saddle thrombus. During the follow-up, neither chest pain nor enzymatic cardiac damage was reported. In this carefully observed case, a less invasive strategy instead of catheter intervention or strong thrombolysis might have led to a favorable clinical outcome.