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.

Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices　- Insight From the OCEAN-LAAC Registry.

BACKGROUND: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). CONCLUSIONS: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

Initial results of transcatheter modification of left atrial appendage by obliteration with device in patients with nonvalvular atrial fibrillation: Real-world data from the TERMINATOR registry.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has increased for those who need alternative to long-term anticoagulation with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: From September 2019, after initiating WATCHMAN (Boston Scientific, Maple Grove, MN, USA) device implantation, we established Transcatheter Modification of Left Atrial Appendage by Obliteration with Device in Patients from the NVAF (TERMINATOR) registry. Utilizing 729 patients' data until January 2022, we analyzed percutaneous LAAC data regarding this real-world multicenter prospective registry. A total of 729 patients were enrolled. Average age was 74.9 years and 28.5 % were female. Paroxysmal AF was 37.9 % with average CHADS2 3.2, CHA2DS2-VASc 4.7, and HAS-BLED score of 3.4. WATCHMAN implantation was successful in 99.0 %. All-cause deaths were 3.2 %, and 1.2 % cardiovascular or unexplained deaths occurred during follow-up [median 222, interquartile range (IQR: 93-464) days]. Stroke occurred in 2.2 %, and the composite endpoint which included cardiovascular or unexplained death, stroke, and systemic embolism were counted as 3.4 % [median 221, (IQR: 93-464) days]. Major bleeding defined as BARC type 3 or 5 was seen in 3.7 %, and there was 8.6 % of all bleeding events in total [median 219, (IQR: 93-464) days]. CONCLUSIONS: These preliminary data demonstrated percutaneous LAAC with WATCHMAN device might have a potential to reduce stroke and bleeding events for patients with NVAF. Further investigation is mandatory to confirm the long-term results of this strategy using this transcatheter local therapy instead of life-long systemic anticoagulation.

Burr entrapment in a percutaneous coronary intervention during rotational atherectomy: An experience with 3195 cases.

OBJECTIVES: Burr entrapment is a potentially life-threatening complication of rotational atherectomy (RA). However, owing to its infrequency, there have been no major reports on burr entrapment. This study aimed to evaluate the incidence, treatment, and outcomes of burr entrapment. METHODS: This multicenter retrospective study analyzed patients who had undergone percutaneous coronary interventions (PCIs) and were treated by RA between May 2013 and March 2022. RESULTS: Of the 22 640 PCI procedures, RA was performed in 3195 patients (14.1%), among whom burr entrapment occurred in 22 patients (0.69%). The mean patient age was 78 ± 8.7 years; 64% were male, and 32% were on dialysis. The entrapped burr size was 1.7 ± 0.2 mm, and the burr/artery ratio was 0.6 ± 0.1. In 20 patients (91%), the burr was extracted by strong manual pullback. The other patients underwent balloon angioplasty at the site of the entrapped burr, which might have provided space for successful burr withdrawal. Major adverse cardiac events occurred in 23% of patients. Tamponade requiring pericardiocentesis occurred in two patients (9%). No patients required emergency surgery or suffered an in-hospital death. CONCLUSIONS: Burr entrapment occurred in 0.69% of patients who had undergone RA. Most burrs were extracted by a strong manual pullback. None required emergency surgery, and there were no in-hospital deaths. The results provide a treatment approach and prognosis for burr stuck in the use of RA.

Impact of Gender on Mortality After Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation.

Recent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between men and women. However, the gender-specific prognostic difference in the long-term follow-up after TEER is still unknown. To evaluate the impact of gender on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data. We retrospectively analyzed 1,233 patients (male 60.3%) who underwent TEER for FMR at 24 centers. The impact of gender on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods. During the 2-year follow-up, 207 all-cause death and 263 hospitalizations for HF were observed after TEER for FMR. Men had a significantly higher incidence of all-cause death than women (18.6% vs 14.1%, log-rank p = 0.03). After adjustment by multivariate Cox regression and PS matching, the male gender was significantly associated with a higher incidence of all-cause mortality after TEER than the female gender (hazard ratio 2.11, 95% confidence interval 1.42 to 3.14 in multivariate Cox regression; hazard ratio 1.89, 95% confidence interval 1.03 to 3.48 in PS matching). The gender-specific prognostic difference was even more pronounced after 1-year of TEER. On the contrary, there was no gender-related difference in hospitalization for HF after TEER. In conclusion, women with FMR had a better prognosis after TEER than men, whereas this was not observed in hospitalization for HF. This result might indicate that women with FMR are more likely to benefit from TEER.

Comparative 2-year outcomes of the Misago stent versus other self-expandable nitinol stents for the endovascular treatment of aortoiliac disease.

BACKGROUND: The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease. METHODS: This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis. RESULTS: The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency. CONCLUSIONS: The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.

Retrieval of an infectious leadless pacemaker with vegetation.

This case discusses the retrieval of a pacemaker with vegetation from a 78-year-old man. It suggests that grasping side of Micra body and pulling Micra into Agilis sheath is a possible technique for retrieval.

Incidence, Predictors, and Clinical Impact of the Impeded-By-Stent Phenomenon After Placing Two-Linked Design New Generation Drug-Eluting Stents.

BACKGROUND: When a catheter device is delivered during percutaneous coronary intervention, its passage can be disrupted by a deployed in a coronary artery. However, the condition and details of this phenomenon, that is impeded-by-stent phenomenon (ISP), remain unclear. METHODS: We designed a prospective, open-label, single-center, observational study to clarify the incidence, predictors, and clinical impact of ISP in drug-eluting stents (DESs). Two independent operators observed and judged the occurrence of ISP, which was defined as all disturbances to a device delivery by deployed DESs. We consecutively used the Ultimaster™ (Terumo, Tokyo, Japan) DES for one month (109 patients, October 2018), followed by the Synergy™ (Boston Scientific Corporation, Marlborough, MA, USA) DES the next month (119 patients, November 2018). RESULTS: DESs (2.5-4.0 mm in diameter) were implanted in 230 de novo coronary vessels. ISPs were observed in 17 of 239 stented segments (7.1 %). Multivariate analysis showed that bifurcation lesions (adjusted odds ratio [OR], 4.2; 95 % confidence interval [CI], 1.5-12.6; p = 0.008), predilatation balloon diameter (mm) (OR, 0.2; 95 % CI, 0.1-0.9; p = 0.03), and Ultimaster™ use (OR, 6.0; 95 % CI, 1.9-27.2; p = 0.002) were independent predictors of ISPs. During the 1.5-year follow-up period, no repeat revascularization or stent thrombosis occurred in patients with ISP. CONCLUSIONS: ISP itself does not trigger notable clinical outcomes, including repeat revascularization and stent thrombosis. However, caution should be considered regarding the latent risk of procedural complications.

Subintimal Tracking and Re-entry Technique for Stent-Jailed Side-Branch Occlusion.

OBJECTIVES: This study aimed to evaluate the clinical effectiveness and outcomes of treatment with the subintimal tracking and re-entry technique for stent-jailed side branch (SB-STAR). SB occlusion is a serious complication of percutaneous coronary intervention (PCI). However, conventional strategies may fail to recanalize the stent-jailed SB. METHODS: We retrospectively analyzed consecutive patients who underwent elective PCI and were treated with SB-STAR at the Sapporo Cardiovascular Clinic in Japan. SB was treated for severe stenosis, reduced thrombolysis in myocardial infarction flow grade, or ischemic signs after main vessel stenting. Technical success during the procedure and clinical and angiographic follow-up findings at 6 months were analyzed. RESULTS: Of the 13,431 PCI procedures performed between January 2016 and June 2021, SB-STAR was performed in 10 patients. The angiographic success rate was 100%. At the 6-month follow-up, no deaths or target-vessel revascularizations had occurred. All patients underwent angiographic follow-up, and 8 of the 10 patients (80%) who underwent SB-STAR had confirmed patency. CONCLUSIONS: SB-STAR can be a bailout strategy to improve the critical situation of stent-jailed SB occlusion. At 6-month follow-up, the SB-STAR had good patency as well as good clinical outcomes.

The "Direct tip injection in occlusive lesions (DIOL)" fashion.

BACKGROUND: The successful intervention for peripheral artery disease is limited by complex chronic total occlusions (CTOs). During CTO wiring, without the use of intravascular or extravascular ultrasound, the guidewire position is unclear, except for calcified lesions showing the vessel path. To solve this problem, we propose a novel guidewire crossing with plaque modification method for complex occlusive lesions, named the "Direct tip Injection in Occlusive Lesions (DIOL)" fashion. MAIN TEXT: The "DIOL" fashion utilizes the hydraulic pressure of tip injection with a general contrast media through a microcatheter or an over-the-wire balloon catheter within CTOs. The purposes of this technique are 1) to visualize the "vessel road" of the occlusion from expanding a microchannel, subintimal, intramedial, and periadventitial space with contrast agent and 2) to modify plaques within CTO to advance CTO devices safely and easily. This technique creates dissections by hydraulic pressure. Antegrade-DIOL may create dissections which extend to and compress a distal lumen, especially in below-the-knee arteries. A gentle tip injection with smaller contrast volume (1-2 ml) should be used to confirm the tip position which is inside or outside of a vessel. On the other hand, retrograde-DIOL is used with a forceful tip injection of moderate contrast volume up to 5-ml to visualize vessel tracks and to modify the plaques to facilitate the crossing of CTO devices. Case-1 involved a severe claudicant due to right superficial femoral artery occlusion. After the conventional bidirectional subintimal procedure failed, we performed two times of retrograde-DIOL fashion, and the bidirectional subintimal planes were successfully connected. After two stents implantation, a sufficient flow was achieved without complications and restenosis for two years. Case-2 involved multiple wounds in the heel due to ischemia caused by posterior tibial arterial occlusion. After the conventional bidirectional approach failed, retrograde-DIOL was performed and retrograde guidewire successfully crossed the CTO, and direct blood flow to the wounds was obtained after balloon angioplasty. The wounds heeled four months after the procedure without reintervention. CONCLUSIONS: The DIOL fashion is a useful and effective method to facilitate CTO treatment.

Coil Embolization for Coronary Artery Perforation: A Retrospective Analysis of 110 Patients.

OBJECTIVE: Coil embolization (CE) for coronary artery perforation (CAP) has not been thoroughly evaluated. This study aimed to evaluate the extent of myocardial damage and impact on cardiac function after CE for CAP. METHODS: A total of 110 consecutive patients treated with CE for CAP were retrospectively identified. The degree of myocardial damage and impact on cardiac function were evaluated. RESULTS: Forty-nine (44.5%) cases involved chronic total occlusions. A guidewire was the cause of perforation in 97 (88.2%) patients. The success rate of CE was 98.2%. Almost all patients were prescribed either antiplatelet drugs or anticoagulant medication or both. Patients with perforation types III and IV were found to be prone to creatinine kinase (CK) elevation and epicardial main vessel perforation, thereby causing myocardial damage. No changes were noted in the ejection fraction (EF) in patients with type V distal perforation and collateral channel perforation, while patients with perforation of the epicardial main vessel may show impaired cardiac function afterward. CONCLUSIONS: CE is safe and effective for treating CAP, especially when collateral channels and distal vessels are involved. Meanwhile, efforts should be taken to prevent CAP in epicardial main vessels since it may be difficult to treat with CS and cause myocardial damage when bailed out with CE leading to vessel sacrifice. We found that it was not necessary to change the anticoagulant regimen after CE owing to its ability to achieve robust hemostasis.

The "needle re-entry" technique for infrainguinal arterial calcified occlusive lesions.

BACKGROUND: Vascular calcification is a predictor of poor clinical outcome during and after endovascular intervention. Guidewire crossing techniques and devices have been developed, but chronic total occlusions (CTOs) with severe calcification often prevent subintimal re-entry. We propose a novel guidewire crossing approach combined needle rendezvous with balloon snare technique, named the "needle re-entry" technique, for treatment of complex occlusive lesions. MAIN TEXT: A 73-year-old female with severe claudication in her right calf with ankle brachial index of 0.62, and a computed tomography angiogram showed a long occlusion with diffuse calcification in superficial femoral artery. She was referred to our department to have peripheral interventions. Since the calcified vascular wall of the lesion prevented the successful re-entry, the "needle re-entry" was performed. First, a retrograde puncture of the SFA, distally to the occlusion, was performed and an 0.018-in. guidewire with a microcatheter was inserted to establish a retrograde fashion. Second, an antegrade 5.0-mm balloon was advanced into a subintimal plane and balloon dilation at 6 atm was maintained. Third, an 18-gauge needle was antegradely inserted from distal thigh to the dilated 5.0-mm balloon. After confirming a balloon rupture by the needle penetration, we continued to insert the needle to meet the retrograde guidewire tip. Then, a retrograde 0.014-in. guidewire was carefully advanced into the needle hole, named the "needle rendezvous" technique. After further guidewire advancement to accomplish a guidewire externalization, the needle was removed. Finally, since the guidewire was passing through the 5.0-mm ruptured balloon, the balloon was withdrawn, and the guidewire was caught with the balloon and successfully advanced into the antegrade subintimal space, named the "balloon snare" technique. After the guidewire was advanced into the antegrade guiding sheath and achieved a guidewire externalization, an endovascular stent graft and an interwoven stent were deployed to cover the lesion. After postballoon dilation, an angiography showed a satisfactory result without complications. No restenosis, reintervention, and limb loss have been observed for one year follow-up period after this technique. CONCLUSIONS: The "needle re-entry" technique is a useful guidewire crossing technique to revascularize femoropopliteal complex CTOs with severe calcification which prevent the achievement of guidewire crossing with the conventional procedures.

Predictors of clinical outcome after rotational atherectomy-facilitated percutaneous coronary intervention in hemodialysis patients.

BACKGROUND: Percutaneous coronary intervention (PCI) in hemodialysis patients with severely calcified and diffused lesions is associated with extremely high rates of major adverse cardiovascular events (MACE), even when facilitated by rotational atherectomy (ROTA). Potential risk factors for MACE with ROTA-facilitated PCI in hemodialysis patients should be identified. METHODS: We retrospectively analyzed a consecutive cohort of patients from the Sapporo Cardiovascular Clinic database, who were on maintenance hemodialysis with severe calcified lesions and treated with ROTA-facilitated PCI. Clinical and interventional procedure characteristics were collected and compared between patients with and without MACE, defined as all-cause death, hospitalization due to heart failure, definite stent thrombosis, or target lesion revascularization (TLR) at 1-year follow-up. The individual outcomes of MACE and TLR in the cohort were presented as Kaplan-Meier percentages. Cox regression analyses were performed to identify independent predictors of MACE. RESULTS: A total of 138 patients undergoing hemodialysis and followed up for 362.50 (243.75, 382.25) days. Sixty-one patients in the cohort had MACE, most of which were TLR (47.5%, 29/61). Cumulative all-cause death at 30-day and 1-year follow-up were 6.52% and 18.8%, respectively. Patients with right coronary artery (RCA) lesions, in-stent restenosis (ISR) lesions, and were more likely to have MACE, even with larger reference vessel diameter and greater acute gain after PCI. Cox regression analysis demonstrated that ISR lesion was positively associated with both MACE (HR 3.21, 95% CI: 1.59-6.48) and TLR (HR 5.08, 95% CI: 1.78-14.47), latter of which was also proved to be significantly related to greater acute gain (HR 1.95, 95% CI: 1.12-3.39). In subgroup analysis, RCA was found to be positively associated with MACE in de novo lesion (HR 2.83, 95% CI: 1.28-6.28). CONCLUSIONS: We found that the overall prognosis of ROTA-facilitated PCI in hemodialysis patients was poor. ISR was a significant risk factor for MACE, especially TLR.

The "Fracking" technique: a novel approach to crack deep calcified plaque in the common femoral artery with hydraulic pressure.

BACKGROUND: The patency achieved by conventional peripheral interventions for atherosclerotic lesions in the common femoral artery (CFA), called the "no stenting zone", is not superior to that achieved by surgical endarterectomy due to calcified plaque occupying the area. Plaque modification strategies to obtain acute gain in CFA patency provide the better clinical outcomes than standard balloon angioplasty. Atherectomy devices, which focus on the modification of superficial calcifications, contribute to the improvement of clinical outcomes. However, deep calcifications resist vessel expansion such that luminal gain is not easily achieved. MAIN TEXT: We propose a novel calcified plaque modification technique, named the "fracking technique" (FT). The term fracking refers to how a rock is fractured by the high hydraulic pressure. In this technique, deep calcifications are cracked with hydraulic pressure via a balloon indeflator through an 18-gauge needle, which punctures calcifications to achieve greater acute luminal gain. Case 1 involved an 81-year-old male with eccentric calcified plaque in the right CFA. Conventional balloon angioplasty for the lesion yielded a suboptimal minimal lumen area (MLA), which increased from 6.2 to 10.7-mm2 on intravascular ultrasound (IVUS). The FT was implemented to obtain a larger MLA. After the FT was repeated at three locations at up to 8-atm, a greater MLA of 27.1-mm2 was achieved without complications. Case 2 involved a 72-year-old male undergoing hemodialysis due to diabetes mellitus who presented with ischemic pain in his right limbs at rest due to severe stenosis with eccentric calcification in the distal CFA. The MLA on IVUS before and after balloon angioplasty was 10.0-mm2 and 13.1-mm2, respectively, and this result was still suboptimal. The FT was attempted and successfully yielded a greater MLA of 28.9-mm2 without complications. Restenosis has not been detected for 2 years follow-up period. CONCLUSIONS: The FT is an effective option for treating calcified CFA lesions to achieve a larger lumen area. Long-term follow-up studies are necessary.