Balloon Post-dilatation Research Articles

The PERFORMANCE II Trial: A Prospective Multicenter Investigation of a Novel Carotid Stent System.

Several randomized clinical trials have shown that the composite endpoint of death, stroke, and myocardial infarction (MI) is equivalent between carotid artery stenting and carotid endarterectomy. However, the risk of minor stroke has been consistently higher with carotid artery stenting. The authors sought to evaluate the safety and effectiveness of a novel carotid stent system comprised of a stent, an adjustable integrated embolic filter and a postdilation balloon, in patients at elevated risk for adverse events from carotid endarterectomy. PERFORMANCE II (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II) was a prospective, multicenter, single-arm study. The primary endpoint was the composite of major adverse events defined as death, all stroke, and MI within 30days of the procedure, plus ipsilateral stroke through 12months. 305 patients were enrolled at 32 centers in the United States and Europe. The mean age was 69.6 ± 7.5 years; 65.9% were male, and 20% were symptomatic. The mean lesion length was 19.1 ± 6.7mm, and 34.5% of lesions were severely calcified. At 30days, there were 4minor strokes (1.3%), with no major strokes. There was 1 cardiac death on day 30, resulting in a stroke/death rate of 1.6% and a stroke/death/MI rate of 2.3%. The 12-month primary endpoint occurred in 2.8%; there were no major strokes, clinically driven target lesion revascularizations, stent thromboses, or neurological deaths. The 30-day all stroke plus ipsilateral stroke through 12months rate was 1.8%. The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients. (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II [PERFORMANCE II]; NCT04201132).

Plaque characteristics associated with failure of primary balloon angioplasty for intracranial atherosclerotic stenosis: a retrospective study

BackgroundPrimary balloon angioplasty (PBA) is an alternative treatment approach for intracranial atherosclerotic stenosis (ICAS); however, its efficacy may be compromised by arterial dissection or early elastic recoil after balloon dilation....

Early safety after TAVR according to VARC-3 criteria: incidence, predictors, and clinical impact.

The Valve Academic Research Consortium (VARC)-3 definition of the early safety (ES) composite endpoint after transcatheter aortic valve replacement (TAVR) lacks clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of ES after TAVR as defined by VARC-3 criteria. We performed a multicenter study including 10 078 patients with severe aortic stenosis undergoing transarterial TAVR. According to VARC-3 criteria, ES at 30 days was defined as freedom from all-cause mortality, stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complications, acute kidney injury stages 3-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, and surgery or intervention related to the device. Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. ES was achieved in 6598 patients (65.5%). The main factors associated with a lack of ES were the occurrence of type 2-4 bleeding (18.9%), and new pacemaker implantation (13.6%). Advanced age, peripheral artery disease, chronic kidney disease, and balloon postdilation were associated with an increased risk of no-ES (P < .01 for all). Failure to achieve ES was associated with higher all-cause mortality up to 1-year after TAVR (HR, 3.17; 95%CI, 2.76-3.65; P < .001). VARC-3 ES was not achieved in up to one-third of contemporary TAVR patients, which was associated with worse mid-term outcomes. The factors associated with increased risk were advanced age, baseline comorbidities, and some procedural features (postdilation). These findings highlight the importance of continued efforts to minimize the risk of TAVR-related procedural complications.

Effects of percutaneous endovascular angioplasty for severe stenosis or occlusion of subclavian artery

To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48–86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.

The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan.

The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

Do we still need intra-procedural TTE during Transcatheter aortic valve replacement? A high volume, single center experience

BackgroundTranscatheter aortic valve implantation (TAVI) has undergone significant advances in recent years, with the development of improved pre-planning tools and devices. These advances have led to a reduction in the rate of paravalvular leak (PVL), a complication that is associated with poor outcomes even when mild. As some centers around the world are moving to solely fluoroscopy-focused implantation, we aimed to describe the clinical impact of intra-procedural transthoracic echocardiography (TTE) during TAVI in a high volume hospital. MethodsObservational study during a 3-month period. A limited TTE examination was performed immediately after deployment to assess the existence of PVL and grade its severity. Complete TTE was performed a day after the procedure. In case of ≥mild PVL after valve deployment, a decision was made according to the severity of the PVL, patient anatomy and extent of annular calcification to preform balloon post-dilation. If done, an additional limited TTE was performed to assess possible complication and the degree of PVL post dilatation. Results115 patient were included in the study. Intra-procedural TTE identified 16 patients (14 %) with at least mild PVL, three of them with moderate (3 %). Post balloon dilatation was performed in 10 patients (9 % of the cohort) with significant improvement in the degree of PVL. ConclusionIntra-procedural TTE immediately after TAVI deployment can accurately identify PVL, allowing operators to perform post balloon dilatation with improvement in early echocardiographic results. Our findings support the routine use of TTE during procedures, without relying solely on fluoroscopy.

Optimising Percutaneous Coronary Interventions: The Impact of Stent Type and Diameter on Long-Term Clinical Outcomes in Large Coronary Arteries.

Background and Objectives: Our study aimed to reveal the effect of using 4 mm bare-metal stents (BMS), 4 mm drug-eluting stents (DES), or 3 mm DES with 4 mm diameter balloon post-dilation strategies on long-term clinical outcomes and endpoints for large-diameter coronary artery percutaneous coronary intervention (PCI). Materials and Methods: In our study, patients who had undergone PCI were retrospectively screened between January 2014 and July 2020. The study included 350 patients and was divided into three groups; Group I (n = 134) included patients with direct 4.0 mm BMS implantation, Group II (n = 109) included patients with direct 4.0 DES implantation, and Group III (n = 107) included patients with 4mm NC post-dilatation after 3 mm DES implantation. Primary endpoints were determined as target lesion revascularisation, cardiac mortality, and myocardial infarction associated with the target vessel. Our secondary endpoint was all-cause mortality. Results: No differences were observed between the groups in terms of the baseline variables. Stent length was the highest in Group II and the shortest in Group III. There were no significant differences between the groups regarding major adverse cardiovascular events (MACE). Conclusions: Our study suggests that in percutaneous coronary interventions for non-complex lesions, there is no significant difference in MACE outcomes when directly implanting a 4 mm diameter DES, a 4 mm diameter BMS, or a 3 mm diameter DES, followed by post-dilation with an appropriately sized NC balloon when the target vessel diameter is in the range of 4 to 4.4 mm.

VARIOUS ASPECTS OF PERCUTANEOUS CORONARY INTERVENTIONS AS PREDICTORS OF DEATH IN MYOCARDIAL INFARCTION AND CORONARY MICROVASCULAR OBSTRUCTION (NO-REFLOW)

HighlightsThe review analyzed the role of various preoperative indicators as predictors of long-term mortality in patients with myocardial infarction and coronary microvascular obstruction (no-reflow) that developed during percutaneous coronary intervention. As a result of a multifactorial analysis, taking into account the confounders available for evaluation, we have found that predilation serves as an independent predictor of death within two years. AbstractAim. To evaluate the role of various aspects of percutaneous coronary interventions (PCI) as predictors of long-term death in myocardial infarction (MI) and coronary microvascular obstruction (CMVO, no-reflow).Methods. The unmatched case-control study included 232 patients with type 1 MI and CMVO developed during PCI. CMVO criteria were as follows: TIMI flow grade &lt;3, Myocardial blush grade &lt;2, ST segment resolution after PCI &lt;70%. The “cases” group consisted of 54 (23.3%) patients who died within the next two years, the “controls” group consisted of 178 (76.7%) patients who survived. The analysis included the following indicators: predilation, high-pressure balloon post-dilation, vacuum assisted manual thromboaspiration, intra-aortic balloon pump, intracoronary administration of isosorbide dinitrate and verapamil hydrochloride, glycoprotein IIb/IIIa inhibitors and “potent” p2y12 inhibitors usage, bare-metal stents, stent implantation with exceeded rated burst pressure, 3 or more stents usage, PCI on more than one artery, the ratio of contrast agent volume to glomerular filtration rate (GFR) &gt;3.0. A univariate comparative analysis of the groups regarding PCI aspects and potential confounders was performed (Mann-Whitney, Fisher). To control the confounders, a multivariate analysis was carried out (logistic regression).Results. Differences were obtained for the following indicators: “predilation” – in 51 (94%) patients in the “cases” group and in 139 (78%) in the “control” group, p-value = 0.005; “intra-aortic balloon pump” – in 9 (17%) and 7 (4%) patients respectively, p-value = 0.003; “the ratio of contrast agent volume to GFR &gt;3.0” – in 26 (48%) and 48 (27%) patients, p-value = 0.005. Multivariate analysis revealed that only predilation was an independent predictor of death within two years – odds ratio 7.38 (95% confidence interval 1.70–49.04, p-value = 0.005).Conclusion. Predilation of the infarct-related coronary artery is an independent predictor of death within two years in MI patients who develop CMVO during PCI.

Evaluation of post-dilatation on longitudinal stent deformation and postprocedural stent malapposition in the left main artery by optical coherence tomography (OCT): an in vitro study

BackgroundThe diameter of the ostial and proximal left main coronary artery can be greater than 5.0 mm. However, the diameters of the mostly available coronary drug-eluting stents (DESs) are ≤ 4.0 mm. Whether high-pressure dilatation can increase the diameter of stents from 4.0 to 5.0 mm and whether post-dilatation leads to longitudinal stent deformation (LSD) of 4.0-mm-diameter stents have rarely been studied. Therefore, this study aims to evaluate LSD and stent malapposition of six types of commercially available 4.0-mm-diameter stents in China in a 5.0-mm-diameter artificial blood vessel model by optical coherence tomography (OCT) in vitro.MethodsThe left main coronary artery was simulated by a truncated cone-shaped silicone tube. The internal diameters were 4.0 mm at one end of the silicone tube and 5.0 mm at the other end. Six different types of coronary stents widely used in China were selected for this study. Each stent was respectively implanted into the simulated blood vessel and dilated to a diameter of 4.2 mm according to the stent-balloon pressure compliance table. The stents were subjected to post-dilatation with a 5.0 × 15-mm noncompliant balloon. The LSD ratio of the longitudinal axis of each stent and stent malapposition were measured through OCT, and any fractures of the stents were determined.ResultsNone of the six types of stents fractured following post-dilatation. The longitudinal axes of the BuMA and Excrossal stents were slightly shortened, while the other stents were elongated after high-pressure post-dilatation. All stents expanded to a diameter of 5.0 mm without incomplete stent apposition, except for the Nano Plus stent, which remained malapposed after high-pressure post-dilatation.ConclusionAll 4.0-mm-diameter stents can be expanded to a diameter of 5.0 mm by noncompliant balloon post-dilatation without stent strut fracture. Most stents were found to be well apposed after high-pressure post-dilatation. However, LSD was observed after post-balloon dilatation. Stent malapposition might be positively correlated with the percentage change in stent length.

Transradial carotid artery stenting using double layer micromesh stent and novel post-dilation balloon with integrated embolic protection

ObjectivesThe highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-ɥm pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation. Methods25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent. No additional embolic protection was used. The Paladin filters were collected following the procedure and preserved in formalin for histological analysis. The contents were evaluated for particle count and size. Subjects were followed for 30 days and evaluated for major cardiac adverse events (death, stroke and MI). Secondary endpoints included procedure success, device success, access site complications according to EASY score classification, major vascular or ischemic complications at follow up and in-stent restenosis rate evaluated with duplex ultrasound. ResultsMean age of patients was 68,5 years. Type 2 aortic arch was present in 77 % of patients and type 1 and type 3 in 12 % and 11 % of patients respectively. Procedural and device success was obtained in all cases without complications. The 30-day MAE rate was 0 %. Twenty-three filters underwent histological analysis. Microscopic debris was present in 100 % of filters, and 75 % of particles were less than 100ɥm in size. The mean number of particles per filter was 3352 ± 1567 (IQR 4300–2343), and the mean number of particles between 40-100ɥm per filter was 2499 ± 1240 (IQR 3227–1575). ConclusionCAS through radial approach can be safely and effectively performed using the IEP technology Paladin device and double-layer micromesh Roadsaver stent. This strategy can simplify the procedure and decrease peri-procedural complications and procedural time.

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism. To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine. Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers. The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001). This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).

Computational study of the balloon dilation steps on transcatheter aortic valve replacement.

Balloon dilation is a commonly used assistant method in transcatheter aortic valve replacement (TAVR) and plays an important role during valve implantation procedure. The balloon dilation steps need to be fully considered in TAVR numerical simulations. This study aims to establish a TAVR simulation procedure with two different balloon dilation steps to analyze the impact of balloon dilation on the results of TAVR implantation. Two cases of aortic stenosis were constructed based on medical images. An implantation simulation procedure with self-expandable valve was established, and multiple models including different simulation steps such as balloon pre-dilation and balloon post-dilation were constructed to compare the different effects on vascular stress, stent morphology and paravalvular leakage. Results show that balloon pre-dilation of TAVR makes less impact on post-operative outcomes, while post-dilation can effectively improve the implantation morphology of the stent, which is beneficial to the function and durability of the valve. It can effectively improve the adhesion of the stent and reduce the paravalvular leakage volume more than 30% after implantation. However, balloon post-dilation may also lead to about 20% or more increased stress on the aorta and increase the risk of damage. The balloon dilation makes an important impact on the TAVR outcomes. Balloon dilation needs to be fully considered during pre-operative analysis to obtain a better clinical result.

Double kissing inflation outside the stent versus jailed balloon technique for coronary bifurcation lesions

Abstract Background Side branch (SB) occlusion remains challenging in percutaneous coronary intervention (PCI) for bifurcation lesions even in the era of jailed balloon technique (JBT). Our previous single-arm study introduced a novel method to protect SB named double kissing inflation outside the stent (DKo), which features twice inflation of the protective balloon kissing with the stent balloon and post-dilation balloon. Objective To confirm whether DKo can protect SB better than JBT in a large sample of bifurcation lesions. Methods This retrospective, single-center cohort study enrolled 875 consecutive patients underwent bifurcation PCI either in DKo (n=209) or JBT group (n=666). The primary endpoint was transient SB loss after removal of the protective balloon. The secondary endpoints included rates of SB rewiring, final kissing balloon inflation (FKBI), SB stenting, final SB loss, and peri-procedural myocardial infarction (PMI). Results Transient SB loss occurred in only 1 patient (0.5%) in DKo but 32 patients (4.8%) in JBT (p&amp;lt;0.005). Transient loss in JBT group was triggered by rewiring (n=21), post-dilation (n=8) and severe dissection (n=3). DKo caused lower rates of rewiring (0.5% vs. 13.8%, p&amp;lt;0.001), FKBI (0.5% vs. 7.7%, p&amp;lt;0.001) and PMI (0.5% vs. 2.9%, p=0.045). SB stenting and final SB loss showed a lower tendency in DKo [0% vs. 0.8%, p=0.21; 0% vs. 1.2%, p=0.11]. DKo was the only protector against transient SB loss [odds ratio=0.08, 95% confidence interval (0.01-0.59), p=0.013]. Conclusion DKo protects SB better than JBT in PCI for bifurcation lesions. Randomized controlled studies are required to confirm the long-term benefit.

The role of post-dilatation in carotid MicroNet-covered stent implantation, evaluated using 3D cone-beam CT angiography.

This study aims to assess the role and safety of post-dilatation in protected carotid artery stenting (PCAS) using the new MicroNet-covered 2nd-generation stent assessed by cone beam CT scans. From March 2020 to March 2022, patients were enrolled in the study according to CT angiography results based on the following criteria: Evidence of 70% to 99% carotid stenosis in asymptomatic patients and 50% to 99% in symptomatic patients, per the NASCET index. Using a FilterWire EZ™ (Boston Scientific, Natick, MA, USA) embolic protection system (EPS), MicroNet-covered stent PCAS was performed by two interventional radiologists with at least 8 years of experience in endovascular intervention. Each patient underwent post-dilatation following stent placement. Finally, a third radiologist (not participating in the interventional procedures) evaluated the cone beam CT scans and calculated residual stenosis. Major and minor complications were recorded in the 30 days following the procedure. A total of 192 patients (121 male, mean age 73±10 years) were included in the study, and all patients received post-dilatation following stent implantation. Technical successes were achieved in all procedures. Adverse events noted in this study were limited to periprocedural transient ischemic attacks that occurred in three out of 192 patients (1.6%) and showed a swift complete recovery. The post-dilatation balloon diameters used in the study were: 5.0 mm (30.3%), 5.5 mm (39.3%) and 6 mm (30.3%). Optimized postdilatation resulted in a significant increase in the final luminal area. Similar improvements were observed in all subtypes of plaque. Post-dilatation in protected CAS is safe and induces a significant improvement in the cross-sectional area regardless of the stenotic plaque.

Incremental prognostic value of intensity-weighted regional calcification scoring using contrast CT imaging in TAVR.

Aortic valve calcification scoring plays an important role in predicting outcomes of transcatheter aortic valve replacement (TAVR). However, the impact of relative calcific density and its causal effect on peri-procedural complications due to sub-optimal valve expansion remains limited. This study aims to investigate the prognostic power of quantifying regional calcification in the device landing zone in the context of peri-procedural events and post-procedural complications based on pre-operative contrast computed tomography angiography (CCTA) images. Assess the effect of calcification on post-procedural device expansion and final configuration. We introduce a novel patient invariant topographic scheme for quantifying the location and relative density of landing zone calcification. The calcification was detected on CCTA images based on a recently developed method using automatic minimization of the false positive rate between aortic lumen and calcific segments. Multinomial logistic regression model evaluation and ROC curve analysis showed excellent classification power for predicting paravalvular leakage [area under the curve (AUC) = 0.8; P < 0.001] and balloon pre-dilation (AUC = 0.907; P < 0.001). The model exhibited an acceptable classification ability for left bundle branch block (AUC = 0.748; P < 0.001) and balloon post-dilation (AUC = 0.75; P < 0.001). Notably, all evaluated models were significantly superior to alternative models that did not include intensity-weighted regional volume scoring. TAVR planning based on contrast computed tomography images can benefit from detailed location, quantity, and density contribution of calcific deposits in the device landing zone. Those parameters could be employed to stratify patients who need a more personalized approach during TAVR planning, predict peri-procedural complications, and indicate patients for follow-up monitoring.

Three-step surgical management algorithm for annular rupture in transcatheter aortic valve replacement

ObjectiveWhereas transcatheter aortic valve replacement is widely implemented, annular rupture is a devastating complication and could be highly mortal. However, owing to its rare incidence, the optimal treatment algorithm has not been established. Thus, we evaluated the feasibility and effectiveness of a 3-step algorithm to treat annulus rupture. MethodsFrom 2009 to 2022, 8 patients of 1083 transcatheter aortic valve implantation (0.8%) developed annulus rupture and were treated with the three-step algorithm. The algorithm was composed of a first step (pericardial drainage and protamine neutralization with blood pressure control), second step (manual hemostatic compression via full/partial sternotomy), and a third step (conservative treatment or radical surgical correction). ResultsThe median age at the procedure was 85 (78-88) years and 7 female patients were included in this study. Two (25%) patients had end-stage renal failure under hemodialysis, and median Society of Thoracic Surgeons score was 8.9% (2.1%-23.2%). The implanted transcatheter heart valves (THVs) were 7 balloon-expandable THVs and 1 self-expandable THV with balloon postdilatation. Under this strategy, 8 (100%) patients underwent pericardial drainage as first step and 5 patients achieved hemostasis. Of these, patient 1 demonstrated bleeding from left sinus of Valsalva and required a Bentall procedure. Although the etiology of this phenomenon was not investigated by contrast-enhanced computed tomography, it might be derived from pseudoaneurysm rupture or delayed annular rupture. In 2 patients, the second step treatment was needed for hemostasis. Third-step treatment was conducted in 1 patient. Postoperatively, 6 patients could be discharged without critical complications whereas 2 patients died during the hospitalization. There were no other complications during the followed-up (584 [7-1614]) days. ConclusionsIn accordance with the three-step algorithm, 6 patients, including those with high-risk or inoperative status, survived.

Incidence and risk factors for hypotension after carotid artery stenting: Systematic review and meta-analysis.

Hypotension is recognized as a common complication after carotid artery stenting, but its incidence and the risk factors associated with it are uncertain. Therefore, we performed a systematic review and meta-analysis to investigate and identify risk factors for hypotension after surgery. We retrieved risk factors from eight databases for case-control and cross-sectional studies of hypotension after carotid artery stenting according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines on 28 November 2022. Data were analyzed by using R4.2.1 and Review Manager 5.3. A total of 2843 samples were searched, and 17 publications were included in the analysis. The meta-analysis results showed that the incidence of hypotension after surgery was 28.6% (95% confidence interval [CI] (0.225, 0.347)). Age ⩾ 65 years (odds ratio [OR] = 4.55, 95% CI (2.50, 8.29), P < 0.00001), stenosis site (bulb) (OR = 4.41, 95% CI (2.50, 7.79), P < 0.00001), severe stenosis (OR = 3.56, 95% CI (1.62, 7.85), P = 0.002), stenosis proximity (⩽ 10 mm) to bifurcation (OR = 2.69, 95% CI (1.74, 4.15), P < 0.00001), calcified plaques (OR = 4.64, 95% CI (1.93, 11.14), P = 0.0006), post-balloon dilation (OR = 5.95, 95% CI (2.31, 15.31), P = 0.0002), bilateral carotid stenting (OR = 30.51, 95% CI (2.33, 399.89), P = 0.009), and intravenous fluid intake/mL on the first postoperative day (mean difference = 444.99, 95% CI (141.40, 748.59), P = 0.004) were risk factors for hypotension after surgery. A high incidence of hypotension was observed after carotid artery stenting. Age, stenosis site, severe stenosis, stenosis proximity to bifurcation, calcified plaques, post-balloon dilation, type of surgery, and intravenous fluid intake were identified as risk factors.

Quantitative aortography for assessment of aortic regurgitation in the era of percutaneous aortic valve replacement.

Paravalvular leak (PVL) is a shortcoming that can erode the clinical benefits of transcatheter valve replacement (TAVR) and therefore a readily applicable method (aortography) to quantitate PVL objectively and accurately in the interventional suite is appealing to all operators. The ratio between the areas of the time-density curves in the aorta and left ventricular outflow tract (LVOT-AR) defines the regurgitation fraction (RF). This technique has been validated in a mock circulation; a single injection in diastole was further tested in porcine and ovine models. In the clinical setting, LVOT-AR was compared with trans-thoracic and trans-oesophageal echocardiography and cardiac magnetic resonance imaging. LVOT-AR > 17% discriminates mild from moderate aortic regurgitation on echocardiography and confers a poor prognosis in multiple registries, and justifies balloon post-dilatation. The LVOT-AR differentiates the individual performances of many old and novel devices and is being used in ongoing randomized trials and registries.

Double Kissing Inflation Outside the Stent Versus Jailed Balloon Technique for Coronary Bifurcation Lesions

Side branch (SB) occlusion remains challenging in bifurcation percutaneous coronary intervention. We have introduced a novel method to protect SB named double kissing inflation outside the stent (DKo), which features twice inflation of protective balloon kissing with stent and postdilation balloon. This study compared protective effects of DKo vs jailed balloon technique (JBT) for bifurcation. This retrospective, single-center study enrolled 875 consecutive bifurcation lesions receiving either DKo (n = 209) or JBT (n = 666). At the 12-month follow-up, major adverse cardiac event occurred less in DKo (6.7% vs 12.0%; P = 0.042), even in 1:2 propensity score matching analysis (6.4% vs 12.3%; P = 0.034). Rewiring and transient SB loss occurred also less in DKo (0.5% vs 13.8% [P < 0.001]; 0.5% vs 4.8% [P = 0.003]). Similar results were observed in matching analysis. This study demonstrated DKo protected SB better than JBT in bifurcation percutaneous coronary intervention.

Clinical Validation of a New Enhanced Stent Imaging Method

(1) Background: Stent underexpansion is the main cause of stent thrombosis and restenosis. Coronary angiography has limitations in the assessment of stent expansion. Enhanced stent imaging (ESI) methods allow a detailed visualization of stent deployment. We qualitatively compare image results from two ESI system vendors (StentBoost™ (SB) and CAAS StentEnhancer™ (SE)) and report quantitative results of deployed stents diameters by quantitative coronary angiography (QCA) and by SE. (2) Methods: The ESI systems from SB and SE were compared and graded by two blinded observers for different characteristics: 1 visualization of the proximal and distal edges of the stents; 2 visualization of the stent struts; 3 presence of underexpansion and 4 calcifications. Stent diameters were quantitatively measured using dedicated QCA and SE software and compared to chart diameters according to the pressure of implantation. (3) Results: A total of 249 ESI sequences were qualitatively compared. Inter-observer variability was noted for strut visibility and total scores. Inter-observer agreement was found for the assessment of proximal stent edge and stent underexpansion. The predicted chart diameters were 0.31 ± 0.30 mm larger than SE diameters (p &lt; 0.05). Stent diameters by SE after post-dilatation were 0.47 ± 0.31 mm smaller than the post-dilation balloon diameter (p &lt; 0.05). SE-derived diameters significantly differed from QCA; by Bland–Altman analysis the bias was −0.37 ± 0.42 mm (p &lt; 0.001). (4) Conclusions: SE provides an enhanced visualization and allows precise quantitative assessment of stent expansion without the limitations of QCA when overlapping coronary side branches are present.