The Impact of Balloon Pre-dilatation Techniques on Drug-Coated Balloon Therapy for Femoropopliteal Artery Disease: Six-Month Results From the CIVILIAN Registry.

OBJECTIVE: The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions. METHODS: This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months. RESULTS: During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83-7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07-3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00-2.69, p=0.048). CONCLUSIONS: By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons. CLINICAL IMPACT: The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.

A systematic review and meta-analysis of predilation and postdilation in transfemoral carotid artery stenting.

OBJECTIVE: In this review, we evaluate the short-term impact of different ballooning combinations on hemodynamic instability neurologic events, and mortality associated with carotid artery stenting. METHODS: We used a search strategy to identify studies in the Cochrane Library trials register, PubMed, EMBASE, Google Scholar, and the US National Library of Medicine clinical trial databases up to May 2019. Studies reporting either hemodynamic instability, neurologic events, or mortality were included according to the recommendations of the Preferred Reporting Items for Systematic reviews and Meta-analysis. Fixed and random models were used to summarize the effects. RESULTS: Of seven included cohort studies for qualitative review, six were selected for meta-analysis. Patients without postdilation had significantly less hemodynamic instability in the random effects model (risk ratio, 0.53; 95% confidence interval, 0.37-0.77; P = .001). Regardless of the dilation type, the overall summary effect in the fixed model showed a significant decrease in the risk of developing short-term neurologic events (risk ratio, 0.67; 95% confidence interval, 0.47-0.97; P = .03). Last, the exclusion of either of the two dilation techniques had no significant effect on mortality. CONCLUSIONS: Avoiding postdilation reduces perioperative hemodynamic instability and this benefit lasts at least up to 30 days. Regardless of the type, fewer dilations during carotid artery stenting possibly decreases the neurologic events during and 30 days after the procedure. The data also suggest that the residual stenoses above current practiced standard may provide a safer threshold to prompt postdilation. Statements about the long-term effects of dilation techniques requires more study.

A modified predilation, sizing, and postdilation scoring system for patients undergoing metallic drug-eluting stent implantations.

OBJECTIVE: This study sought to assess whether the predilation, scaffold/stent sizing, and postdilation (PSP) score for bioresorbable scaffold (BRS) implantation was associated with outcomes following metallic drug-eluting stent (DES) implantation. BACKGROUND: The PSP score is associated with patients' prognoses after BRS implantation. METHODS: This study involved 2,348 patients who underwent biodegradable polymer DES implantations during the PANDA III trial. The optimal PSP technique was defined according to previous studies of BRS implantations. The main outcome was target lesion failure (TLF) that comprised cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: Twenty-five (1.1%) patients fulfilled all the PSP criteria. The BRS-derived PSP score was of limited prognostic value for 2-year TLF after metallic DES implantation; optimal sizing was a protective factor, but optimal predilation was a risk factor. We built a new PSP model for DESs by identifying the following risk factors: predilation performed with a residual stenosis ≥70% or a balloon-to-quantitative coronary angiography (QCA)-determined reference vessel diameter (RVD) ratio >1:1, sizing performed with an RVD <2.25 mm or a stent diameter >0.25 mm wider than the QCA-RVD, a postprocedural stenosis diameter ≥30%, age, and the baseline SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) score. The new PSP scoring system predicted 2-year TLF (area under the curve, 0.69; 95% confidence interval, 0.65-0.73); a cutoff value of 19.2 points identified high-risk patients. CONCLUSIONS: The new PSP scoring system, based on redefined PSP criteria, age, and the SYNTAX score, could help optimize metallic DES implantations.

Degree of valve calcification in patients undergoing transfemoral transcatheter aortic valve implantation with and without balloon aortic valvuloplasty: Findings from the multicenter EASE-IT TF registry.

AIMS: We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes. METHODS AND RESULTS: EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients. Data for 178 patients (55 BAV; 123 no BAV) were analyzed. There were no significant differences between groups in terms of regional/leaflet sector calcification volumes, maximum asymmetry between the different leaflet sectors, or total calcification scores. Overall, a greater-than-average leaflet calcification volume was independently predictive of ≥mild PVL (OR: 5.116; 95% CI: 1.042-38.35) and the need for post-dilation (OR: 3.592; 95% CI: 1.173-12.14). The latter effect was abated in patients with BAV (OR: 1.837; 95% CI: 0.223-18.00) and intensified in those without BAV (OR: 5.575; 95% CI: 1.114-38.74). No other BAV-dependent effects of calcification on outcomes were observed. CONCLUSIONS: In the majority of transfemoral valve implantations, calcification does not appear to be the main driving factor in the decision to perform/omit BAV. Predilation may be valuable for reducing post-dilation requirements in patients only with a greater degree of leaflet calcification.

Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation - results of a meta-analysis of 3 multicenter registries.

BACKGROUND: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis. METHODS: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes. RESULTS: Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30. CONCLUSIONS: This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

Effect of Side Branch Predilation in Coronary Bifurcation Stenting With the Provisional Approach　- Results From the COBIS (Coronary Bifurcation Stenting) II Registry.

BACKGROUND: Whether side branch (SB) predilation before main vessel (MV) stenting is beneficial is uncertain, so we investigated the effects of SB predilation on procedural and long-term outcomes in coronary bifurcation lesions treated using the provisional approach.Methods and Results:A total of 1,083 patients with true bifurcation lesions undergoing percutaneous coronary intervention were evaluated. The primary outcome was a major adverse cardiovascular event (MACE): cardiac death, myocardial infarction, or target lesion revascularization. SB predilation was performed in 437 (40.4%) patients. Abrupt (10.5% vs. 11.3%; P=0.76) or final SB occlusion (2.7% vs. 3.9%; P=0.41) showed no differences between the predilation and non-predilation groups. The rates of angiographic success (69.1% vs. 52.9%, P<0.001) and SB stent implantation (69.1% vs. 52.9%, P<0.001) were significantly higher in the predilation group. During a median follow-up of 36 months, we found no significant difference between the groups in the rate of MACE (9.4% vs. 11.5%; P=0.67) in a propensity score-matched population. In subgroup analysis, patients with minimal luminal diameter of the parent vessel ≤1 mm benefited from SB predilation in terms of preventing abrupt SB occlusion (P for interaction=0.04). CONCLUSIONS: For the treatment of true bifurcation lesions, SB predilation improved acute angiographic and procedural outcomes, but could not improve long-term clinical outcomes. It may benefit patients with severe stenosis in the parent vessel.

Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

OBJECTIVES: To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BACKGROUND: BAV was considered a mandatory previous step in TAVR procedures. METHODS: A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. RESULTS: Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. CONCLUSIONS: Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc.

Effect of balloon pre-dilation on performance of self-expandable nitinol stent in femoropopliteal artery.

Balloon pre-dilation is usually performed before implantation of a nitinol stent in a femoropopliteal artery in a case of severe blockage or calcified plaque. However, its effect on performance of the nitinol stent in a diseased femoropopliteal artery has not been studied yet. This study compares the outcomes of stenting with pre-dilation and without it by modelling the entire processes of stent deployment. Fatigue deformation of the implanted stent is also modelled under diastolic-systolic blood pressure, repetitive bending, torsion, axial compression and their combination. Reduced level of stress in the stent occurs after stenting with pre-dilation, but causing the increased damage in the media layer, i.e. the middle layer of the arterial wall. Generally, pre-dilation increases the risk of nitinol stent's fatigue failure. Additionally, the development of in-stent restenosis is predicted based on the stenting-induced tissue damage in the media layer, and no severe mechanical irritation is induced to the media layer by pre-dilation, stent deployment or fatigue loading.

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.

TAVI With or Without Predilation: Trends From a Large, Propensity-Score Weighted German Aortic Valve Registry (GARY) Population.

BACKGROUND AND AIMS: Currently, it is unclear whether transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI; d-TAVI) or with preimplantation balloon valvuloplasty (b-TAVI) provides similar clinical safety and efficacy. Therefore, we analyzed patients undergoing d-TAVI or b-TAVI for severe aortic stenosis (AS) with either self-expanding or balloon-expandable transcatheter heart valves (THVs) from the German Aortic Valve Registry (GARY). METHODS: Between 2011 and 2017, a total of 44,783 TAVI patients were collected, with 25,717 (57.4%) receiving a balloon-expandable THV and 19,066 (42.6%) receiving a self-expanding THV. A propensity-score weighted model was used to compare d-TAVI vs b-TAVI regarding differences in outcome. RESULTS: B-TAVI was performed in 71% and d-TAVI was performed in 29% of patients. In the investigated time interval, frequency of b-TAVI declined from 88.4% to 58.2%, accompanied by a constant rate of postdilation. After propensity weighting of patients receiving balloon-expandable THV, d-TAVI vs b-TAVI was associated with more frequent postoperative transvalvular mean pressure gradients (mPG) >15 mm Hg (20.7% vs 18.4%; P<.001), similar rates of paravalvular leakage (PVL) ≥ moderate (18.0% vs 16.9%; P=.08), fewer postdilations (13.4% vs 15.5%; P<.001), and fewer complications (permanent pacemaker implantation, 10.2% vs 11.9% [P=.01]; vascular complications, 1.9% vs 2.6% [P<.01]; pericardial tamponade, 0.5% vs 0.9% [P<.01]; and stroke, 0.9% vs 1.3% [P=.02]). In patients receiving self-expanding THVs, d-TAVI vs b-TAVI was associated with more frequent postimplantation mean PG ≥ 15 mm Hg (12.7% vs 10.4%; P<.01), higher rates of PVL ≥ moderate (24.8% vs 16.5%; P<.001), and similar complication rates including permanent pacemaker implantation. CONCLUSIONS: The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.

Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial.

[Figure: see text].

Pre-dilation and Post-dilation in Transcatheter Aortic Valve Replacement: Indications, Benefits and Risks.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with symptomatic severe aortic stenosis. In recent years, an emphasis has been placed on simplification of the procedure. Balloon predilation was initially considered a mandatory step to cross and prepare the stenotic aortic valve, but several studies demonstrated the feasibility of performing TAVR without balloon valvuloplasty. Balloon postdilation of the implanted valve is sometimes required to optimise results, although many patients do not require this step. Contemporary consensus advocates an individualised approach to TAVR procedures and so balloon pre- and post-dilation are performed selectively. This review aims to outline the advantages and disadvantages of balloon pre- and post-dilation and to identify the scenarios in which they are required during TAVR procedures.

Sequential interventional therapy for Budd-Chiari syndrome associated with fresh inferior vena cava thrombosis.

OBJECTIVE: Our study aimed to evaluate the safety and efficacy of sequential interventional therapy for Budd-Chiari syndrome (BCS) caused by obstruction of the inferior vena cava (IVC) with fresh thrombus in the IVC. METHODS: Full medical records were obtained for 20 patients with BCS associated with fresh IVC thrombus who received sequential interventional therapy from 2014 to 2019 at our hospital. All patients underwent small-diameter percutaneous transluminal angioplasty (PTA) balloon catheter predilation combined with sequential catheter-directed thrombolysis and large-diameter PTA balloon dilation. Ultrasound examinations were performed at 1 week, 1 month, 3 months, and every 6 months thereafter. Therapeutic effects and perioperative and postoperative adverse effects were recorded to assess the safety of the treatment. RESULTS: All 20 patients were treated with small PTA balloon catheters (diameter, 10-14 mm) to predilate the occlusive segment of the IVC. Urokinase 400,000 to 600,000 (465,000 ± 93,000) units was administered to patients through the catheter for 6 to 20 (9.7 ± 4.2) consecutive days postoperatively. Ultrasound re-examination showed that the IVC thrombus disappeared completely in 14 patients (70.0%), and a small amount of the old thrombus remained in 6 patients (30.0%). After thrombolysis, all 20 patients received PTA balloon dilation (diameter, 26-30 mm) in the stenosed IVC segment, and blood flow recovered subsequently. No pulmonary embolism or death occurred in the perioperative course. The perioperative survival rate was 100.0%. CONCLUSIONS: Sequential interventional therapy for BCS associated with fresh IVC thrombus is safe and effective.

Impact of Predilation Before Transcatheter Aortic Valve Implantation with New-Generation Devices.

BACKGROUND: Significant aortic stenosis can be effectively treated with transcatheter aortic valve implantation (TAVI) in patients at high or intermediate surgical risk. Predilation is often performed to facilitate TAVI implantation, but its risk-benefit balance with new-generation devices is detabed. We aimed to appraise whether predilation is still needed with new-generation devices for TAVI. METHODS/MATERIALS: We queried the prospective multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study, comparing patients with vs without predilation receiving Acurate, Evolut, Lotus, Portico, or Sapien3. Baseline, procedural features and early clinical and echocardiographic results were compared with unadjusted and adjusted analyses. RESULTS: A total of 1409 subjects were included, 1055 (74.9%) receiving predilation, and 354 (25.1%) undergoing direct TAVI. Several baseline and procedural differences were evident at unadjusted analysis between the two groups, including device success, procedural success, contrast volume, procedural time, mean post-procedural gradient, and prevalence of aortic regurgitation 2+ (all p < 0.05). Adjusted analysis showed that only procedural time remained significantly impacted by predilation (average reduction in procedural time with predilation of -12.9 [95% confidence interval -21.0; -4.8] minutes, p = 0.002). Subgroup unadjusted and adjusted analysis showed that predilation was associated with shorter procedural times only when Evolut or Portico devices were used (all p < 0.05). Clinical and echocardiographic follow-up up to 1 month showed similar results irrespective of predilation at both unadjusted and adjusted analysis. CONCLUSION: TAVI without predilation is not associated with adverse procedural, clinical or echocardiographic results when new-generation devices are used. Predilation may however reduce procedural time with Evolut and Portico devices.

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation.

OBJECTIVE: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. METHODS: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (- balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. RESULTS: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). CONCLUSIONS: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.

Transfemoral aortic valve implantation using a self-expanding transcatheter heart valve without pre-dilation.

BACKGROUND: The aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible. METHODS: Between December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥ 2°, and rate of post-dilation. RESULTS: Median [IQR] age in patients without pre-dilation was 82.7 years [78.6­85.6], STS score was 4.6% [3.4­6.1], and AVC-score was 1436 AU [1043­1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥ 2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0 min [27.0­38.8] vs. 43.0 min [34.3­52.0]; p < 0.001) and fluoroscopy times (7.4 min [5.7­9.0] vs. 9.9 min [7.9­13.5]; p < 0.001). CONCLUSION: In select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases.

Iatrogenic Ascending Pharyngeal Artery Injury by Predilation Balloon Inflation During Carotid Artery Stenting with Flow Reversal.

BACKGROUND: The ascending pharyngeal artery (APA) may rarely arise from the common carotid artery bifurcation. We report an injury to the APA as an unusual complication of predilation balloon inflation during carotid artery stenting (CAS) with flow reversal. CASE DESCRIPTION: A 73-year-old man presented with symptomatic severe left cervical internal carotid artery stenosis. The left APA arose from the common carotid artery bifurcation. We performed CAS with flow reversal to decrease the risk of distal embolization. When we attempted to catheterize the internal carotid artery under roadmap guidance for predilation, we did not notice that the balloon catheters had advanced into the APA owing to the absence of an anterograde angiogram, and the APA was injured when the balloon catheters were inflated. CONCLUSIONS: Our case emphasizes the importance of performing a detailed anatomic assessment before CAS and ensuring adequate angiographic visualization during the procedure under flow reversal when the origin of the APA is in the vicinity of the origin of the internal carotid artery.

Numerical Simulation of Stent Angioplasty with Predilation: An Investigation into Lesion Constitutive Representation and Calcification Influence.

It is acceptable clinical practice to predilate a severely occluded vessel to allow better positioning of endovascular stents, and while the impact of this intervention has been examined for aggregate response in animals there has been no means to examine whether there are specific vessels that might benefit. Finite element methods offer the singular ability to explore the mechanical response of arteries with specific pathologic alterations in mechanics to stenting and predilation. We examined varying representations of atherosclerotic tissue including homogeneous and heterogeneous dispersion of calcified particles, and elastic, pseudo-elastic, and elastic-plastic constitutive representations of bulk atherosclerotic tissue. The constitutive representations of the bulk atherosclerotic tissue were derived from experimental test data and highlight the importance of accounting for testing mode of loading. The impact of arterial predilation is presented and, in particular, its effect on intimal predicted damage, atherosclerotic tissue von Mises and maximum principal stresses, and luminal deformation was dependent on the type of constitutive representation of diseased tissue, particularly in the presence of calcifications.

Comparing Direct Stenting With Conventional Stenting in Patients With Acute Coronary Syndromes: A Meta-Analysis of 12 Clinical Trials.

Our aim was to compare direct stenting (DS) with conventional stenting (CS) in patients with acute coronary syndrome (ACS). We searched PubMed, EMBASE, and ISI web of science for eligible studies. Primary end point was major adverse cardiac events (MACEs) in short term. Secondary end points were 1-year mortality and after-procedural no-reflow phenomenon. Twelve trials in 8998 patients were included. The odds ratios (ORs) were pooled using the Mantel-Haenszel fixed effect model. Short-term MACEs were significantly reduced in the DS arm in contrast to the CS (5.00% vs 8.08%, DS vs CS, respectively, OR [95% confidence interval] = 0.61 [0.46-0.80], P = .0004). One-year mortality and after-procedural no-reflow phenomenon were significantly lower in the DS group. No heterogeneity was observed through I(2) test (Phet = .81, .89, and .77 for each end point, respectively). This meta-analysis demonstrated that in selected patients with ACS, DS is not only safe and feasible but also reduces short-term and 1-year mortality as well as the occurrence of after-procedural no-reflow phenomenon.

Usefulness of echocardiographic criteria for transcatheter aortic valve implantation without balloon predilation: a single-center experience.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an alternative therapy for high-risk patients with symptomatic aortic stenosis. TAVI without balloon aortic predilation (BPD) has been found to be as feasible and safe as the standard approach with predilation. The aim of this study was to show the usefulness of transesophageal echocardiographic (TEE) criteria during patient selection for TAVI without BPD and compare the results with those from a control group. METHODS: Two hundred forty-nine consecutive patients with severe symptomatic aortic stenosis underwent echocardiographic evaluation before TAVI. Two-dimensional and three-dimensional TEE imaging was used to evaluate the aortic annulus and root, leaflet mobility and degree of calcification, orifice characteristics, valve area, and aortic regurgitation. After TEE data were reviewed, patients were considered to be favorable candidates, or not, for TAVI without BPD on the basis of specific echocardiographic criteria. RESULTS: The mean age was 82 ± 5 years. Seventy-nine patients underwent TAVI without BPD, and 170 patients underwent TAVI with BPD. The mean aortic valve area was 0.61 ± 0.16 cm(2), and the mean aortic annular diameter was 2.2 ± 0.25 cm. In the group without BPD, Edwards SAPIEN XT valves were implanted in 64.6% (n = 51) and Medtronic CoreValve prostheses in 35.4% (n = 28). In this group, residual paravalvular aortic regurgitation immediately after valve deployment was seen in 53.2% of patients, without differences from those who underwent TAVI with BPD. Permanent pacemaker implantation was less frequent in the group of patients without BPD (6.3% vs 14.1%, P = .030). Procedure-related mortality was significantly lower in patients without BPD (2.5% vs 11.8%, P = .018). CONCLUSIONS: Thorough TEE assessment of aortic valve features permits the selection of patients with ideal conditions for TAVI without BPD, regardless of the type of prosthesis. Using the echocardiographic criteria described here, it is possible to achieve a good rate of procedural success with a low complication rate in patients undergoing TAVI without BPD.