The "Pre-Rotating Dilator Technique" for Optimal Endograft Orientation in Complex Endovascular Aortic Repair.

PURPOSE: To describe a novel technique for optimal orientation and accurate deployment of aortic endografts during complex endovascular aortic repair (cEVAR). TECHNIQUE: After establishing the femoral access in the standard fashion, a long large-bore dilator is inserted before the cEVAR delivery system. The dilator is advanced beyond the renovisceral segment noticing the degree of axial rotation. The endograft markers are verified with fluoroscopy outside the patient in the standard way. Thereafter, the cEVAR delivery system is pre-emptively rotated by the same degree in the opposite direction than the dilator showed upon insertion. The endograft is then advanced into position with the markers ending with the markers roughly in position. Minor adjustments are done before and during deployment if needed as per standard technique. CONCLUSION: The use of long, large-bore dilator before the introduction of the aortic graft allows to proactively minimize the risk of endograft misalignment and malrotation especially in cases with challenging anatomies in both the visceral and iliac segments. This can potentially be used in all cases because it minimizes the manipulation of the delivery system and potentially increases the accuracy of endograft deployment. CLINICAL IMPACT: This report describes a novel technique involving the use of a long large-bore dilator to predict the degree of rotation of the cEVAR delivery system during insertion and thereby enabling a pre-emptive compensation. This facilitates the precise orientation of the main aortic endograft with an easier alignment of any branches and/or fenestrations to their respective target arteries. This approach holds the potential to mitigate several of the difficulties commonly encountered with current cEVAR solutions, especially the challenges posed by small and tortuous access and severe angulation in the iliac and visceral aortic segment.

Valve implantation for successful sealing of a balloon predilatation-induced annular rupture during transcatheter aortic valve replacement.

Annular rupture is a rare and dreaded complication of transcatheter aortic valve replacement (TAVR) and even rarer when caused by predilatation balloon aortic valvuloplasty. This complication often presents as sudden cardiac tamponade with hypotension and requires urgent intervention. The traditional rescue strategy for patients with annular rupture is emergency surgical repair. However, the mortality rate is still high, considering that most patients who undergo TAVR are not candidates for conventional cardiac surgery. Therefore, there is a need for additional emergency treatment strategies to decrease mortality. This report describes a case of predilatation-induced annular rupture during TAVR that was successfully sealed at the rupture site by valve implantation. This case suggests that continuing with valve deployment may be a successful treatment for predilatation-induced annular rupture during TAVR.

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

BACKGROUND: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR). METHODS: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions. RESULTS: No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success. CONCLUSION: While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

One-year clinical and echocardiographic outcomes of direct implantation of a self-expanding valve.

OBJECTIVE: To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial. BACKGROUND: Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking. METHODS: DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded. RESULTS: At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm2 vs. 1.85 ± 0.44 cm2 , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation (5-6.6 vs. 4-5.7%, respectively) at 1 year. The same applied independently from the performance of post-dilatation at baseline. CONCLUSIONS: Direct, without pre-dilatation, implantation of a self-expanding valve has no impact on one-year clinical and echocardiographic outcomes, independently also from the baseline performance of post-dilatation.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement-Systematic review and meta-analysis of randomized controlled trials and prospective-matched cohorts.

BACKGROUND: This systematic review and meta-analysis aimed to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before transcatheter aortic valve replacement (TAVR). METHODS: We performed a systematic literature search up until March 2020 from PubMed, SCOPUS, EuropePMC, Cochrane Central Database, ProQuest, and ClinicalTrials.gov. We included randomized controlled trial (RCT) and prospective-matched cohorts that compared direct TAVR and preimplantation balloon valvuloplasty before TAVR. The primary outcome was the device success as defined by Valve Academic Research Consortium 2. The secondary outcome was a patient-prosthesis mismatch, the need for balloon postdilatation, composite adverse events, and 1-year mortality. RESULTS: There were a total of 3078‬ patients from eight studies. This meta-analysis showed that direct TAVR has a similar device success rate (P = .63), the need for postdilatation (P = .82), and composite adverse events (P = .98) compared with preimplantation balloon valvuloplasty. Subgroup analysis for balloon-expandable valves showed lower need for balloon postdilatation (risk ratio [RR], 0.63 [0.47, 0.84]; P = .002; I2 , 0%) in direct TAVR group but higher incidence of acute kidney injury (RR, 3.23 [1.25, 8.40]; P = .02; I2 , 0%) and major/life-threatening bleeding (RR, 1.54 [1.17, 2.02]; P = .002; I2 , 0%). Subgroup analysis for the RCTs alone and RCTs + propensity-matched cohorts showed similar device success and composite adverse events in both groups. However, pooled RCTs showed a higher need for balloon postdilatation in direct TAVR (RR, 1.83 [1.03, 3.24]; P = .04; I2 , 0%). CONCLUSION: Direct TAVR has similar efficacy and safety to preimplantation balloon valvuloplasty. However, better-designed RCTs are required before drawing a definite conclusion.

Is side branch lesion length an independent predictor of acute side branch occlusion in provisional strategy? Analysis of 524 consecutive bifurcation lesions.

OBJECTIVES: To detect the impact of side branch (SB) lesion length on acute SB occlusion after main vessel (MV) stenting. METHODS: Five hundred sixteen consecutive patients with 524 bifurcation lesions undergoing one-stent techniques were studied. Multivariate logistic regression analysis was performed to identify independent predictors of acute SB occlusion. The lesions were also further divided into two groups according to the median SB lesion length. The incidences of SB occlusion and lesion characteristics in the two subgroups were compared. RESULTS: The SB lesion length was not significantly different between lesions with and without SB occlusion. In the SB occlusion group, the distance between the position of the minimal lumen diameter and SB ostium was significantly shorter than that in the non-SB occlusion group (1.76 ± 1.04 mm vs. 2.72 ± 2.65 mm; P = 0.0003). Multivariate logistic regression analysis showed that high BA before stenting, plaque accumulation located on the same side as the SB, the Thrombolysis In Myocardial Infarction (TIMI) flow grade of the SB before stenting, and the DS of the SB before MV stenting were independently predictive of SB occlusion. CONCLUSIONS: SB lesion length cannot be regarded as an independent predictor of acute SB occlusion after MV stenting.

Can "true bifurcation lesion" actually be regarded as an independent risk factor of acute side branch occlusion after main vessel stenting?: A retrospective analysis of 1,200 consecutive bifurcation lesions in a single center.

OBJECTIVES: True bifurcation lesion (TBL) is conventionally considered as a risk factor for acute side branch (SB) occlusion when using a single-stent strategy to treat bifurcation lesions. The impact of TBLs on acute SB occlusion after main vessel (MV) stenting was investigated. METHODS: A total of 1,170 consecutive patients with 1,200 bifurcation lesions undergoing one-stent or provisional two-stent techniques were studied. The TBLs were divided into two groups depending on their Medina classification. Multivariate logistic regression analysis was performed to identify independent predictors of acute SB occlusion. According to the median diameter of stenosis (DS) in the MV and the SB after pre-dilatation, the TBL group was divided into three subgroups: subgroup I (DS of both the MV and the SB

Impact of direct stenting on outcome of patients with ST-elevation myocardial infarction transferred for primary percutaneous coronary intervention (from the EUROTRANSFER registry).

OBJECTIVES: We sought to evaluate the impact of direct stenting technique on angiographic and clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary angioplasty (PCI). METHODS: Data on 1,419 patients who underwent immediate PCI for STEMI with implantation of ≥1 stent within native coronary artery were retrieved from the EUROTRANSFER Registry database. Patients were stratified based on the stent implantation technique: direct (without predilatation) vs. conventional stenting. Propensity score adjustment was used to control possible selection bias. RESULTS: Direct stenting technique was used in 276 (19.5%) patients. Remaining 1,143 patients were treated with stent implantation after balloon predilatation. Direct compared with conventional stenting resulted in significantly greater rates of postprocedural TIMI grade 3 flow (conventional vs. direct stenting: 91.5% vs. 94.9%, adjusted OR 2.09 (1.13-3.89), P = 0.020), and lower risk of no-reflow (3.4% vs. 1.4%, adjusted OR 0.31 (0.10-0.92), P = 0.035). The rates for ST-segment resolution >50% after PCI were higher in patients treated with direct stenting technique (76.3% vs. 86.2%, adjusted OR 1.64 (1.10-2.46), P = 0.016). A significant reduction in 1-year mortality in patients from the direct stenting group compared with the conventional stenting group, even after adjustment for propensity score was observed (6.5% vs. 2.9%, adjusted OR 0.45 (0.21-0.99), P = 0.047). CONCLUSIONS: When anatomically and technically feasible, the use of direct stenting technique may result in improved long-term survival in patients with STEMI undergoing primary PCI.

Usefulness of non-slip element percutaneous transluminal angioplasty scoring balloons in treating severe calcified lesions of the carotid artery for carotid artery stenting: A case report.

Background: Treatment of calcified lesions with conventional angioplasty balloons can be difficult due to insufficient lumen expansion, high dissection rates, and repeated revascularization. We report a case in which a scoring balloon was used in lesions resistant to angioplasty with a semi-compliant balloon. Case Description: A 72-year-old man presented with severe stenosis and a highly calcified lesion in the right cervical internal carotid artery. Right carotid artery stenting (CAS) was planned to prevent future ischemic stroke events. Conventional semi-compliant balloon angioplasty was unsuccessful. Three inflations of a non-slip element (NSE) percutaneous transluminal angioplasty (PTA) scoring balloon (Nipro, Osaka, Japan) successfully achieved CAS without complications. Conclusion: This is the first report to describe the use of this scoring balloon in de novo carotid artery disease. NSE PTA scoring balloon catheters can be a useful option for refractory, highly calcified stenosis.

Transcatheter aortic valve implantation without balloon predilatation: not always feasible.

Balloon predilatation has been regarded as an essential step before implanting the self-expandable prosthesis during transcatheter aortic valve implantation (TAVI). Recent evidence showed that without balloon predilatation, an implantation success rate of >95% could be achieved. We report two cases in which balloon predilatation was not performed initially during TAVI but eventually required it to facilitate device crossing and implantation. They illustrated the importance of case selection and alerted us the potential limitation in performing TAVI without balloon predilatation.

Direct transcatheter aortic valve implantation (TAVI) decreases silent cerebral infarction when compared to routine balloon valvuloplasty.

PURPOSE: Silent cerebral infarctions (SCI), as determined by neuron-specific enolase (NSE) elevations, may develop after the transcatheter aortic valve implantation (TAVI) procedure. Our aim in this study was to compare the SCI rates between patients who underwent routine pre-dilatation balloon aortic valvuloplasty (pre-BAV) and patients who underwent direct TAVI without pre-BAV. METHODS: A total of 139 consecutive patients who underwent TAVI in a single center using the self-expandable Evolut-R valve (Medtronic, Minneapolis, Minnesota, USA) were included in the study. The first 70 patients were included in the pre-BAV group, and the last 69 patients were included in the direct TAVI group. SCI was detected by serum NSE measurements performed at baseline and 12 h after the TAVI. New NSE elevations > 12 ng/mL after the procedure were counted as SCI. In addition, SCI was scanned by MRI (magnetic resonance imaging) in eligible patients. RESULTS: TAVI procedure was successful in all of the study population. Post-dilatation rates were higher in the direct TAVI group. Post-TAVI NSE positivity (SCI) was higher in the routine pre-BAV group (55(78.6%) vs. 43(62.3%) patients, p = 0.036) and NSE levels were also higher in this group (26.8 ± 15.0 vs. 20.5 ± 14.8 ng/ml, p = 0.015). SCI with MRI was found to be significantly higher in the pre-BAV group than direct TAVI group (39(55.1%) vs. 31(44.9%) patients). The presence of atrial fibrillation and diabetes mellitus (DM), total cusp calcification volume, calcification at arcus aorta, routine pre-BAV and failure at first try of the prosthetic valve implantation were significantly higher in SCI (+) group. In the multivariate analysis, presence of DM, total cusp calcification volume, calcification at arcus aorta, routine pre-BAV and failure at first try of the prosthetic valve implantation were significantly associated with new SCI development. CONCLUSIONS: Direct TAVI procedure without pre-dilation seems to be an effective method and avoidance of pre-dilation decreases the risk of SCI development in patients undergoing TAVI with a self-expandable valve.

Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation.

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Impact of balloon predilatation in patients with reduced versus preserved ejection fraction during transcatheter aortic valve implantation.

BACKGROUND: Although there is a trend toward direct transcatheter aortic valve implantation (TAVI), still balloon predilatation is necessary in some cases, especially in patients with severe calcification. However, predilatation including rapid ventricular pacing may have adverse outcomes, especially in patients with reduced ejection factor (EF). OBJECTIVE: To evaluate the impact of predilatation on in-hospital outcomes in patients with reduced versus preserved EF underwent TAVI. METHODS: This was a prospective observational study including 110 patients (72 patients with preserved EF (≥50%) and 38 patients with reduced EF (<50%)) who underwent TAVI. The two groups were compared regarding in-hospital outcomes. RESULTS: Predilatation was done routinely in all 110 patients. The mean age was significantly higher in patients with preserved EF (82.76 ± 5.74 vs. 80.13 ± 6.51 years; p = 0.03). The majority (51.4%) of patients with preserved EF were females but the majority (73.7%) of those with reduced EF were males (P < 0.001). Predilatation showed no statistical difference regarding in-hospital mortality (2.6% vs. 1.4%; p = 0.29), hemodynamic instability (5.3% vs. 0.0%; p = 0.11), stroke (0% vs. 1.4%; p = 0.67), conduction defects (13.2% vs. 19.4%; p = 0.29), permanent pacemaker implantation (7.9% vs. 5.5%; p = 0.45), paravalvular leakage (5.3% vs. 2.8%; p = 0.42), vascular complications (7.9% vs. 11.1%; p = 0.43), and acute kidney injury (7.9% vs. 7%; p = 0.4) in patients with reduced versus preserved EF, respectively. CONCLUSION: When balloon predilatation is inevitable during TAVI it is safe in patients with reduced as well as preserved EF with no added risk of hemodynamic instability or other outcomes.

The Pre-dilatation of vessels: A simple method to recruit small caliber veins for creating distal fistulas.

Maturation failure remains a major clinical problem of distal arteriovenous fistula (AVF). Early failure (EF) is associated with the small size of the veins. For about 10 years we have used in more than 1000 fistulas, the Vessels Pre-Dilatation (VPD) to increase the recruitment of small veins for creating distal AVFs. The purpose of this study is to highlight if the VPD can reduce the incidence of EF or failure to mature (FTM) in AVFs created with small veins. Data of all the consecutive patients directly admitted to our Department for their first distal AVF from January to December 2019 were collected. The patients were divided in two groups, one with a vein diameter after the tourniquet ⩽2.0 mm (G1) and one >2 mm (G2). Both in G1 then in G2 the vessels had undergone VPD. Immediate failure (IF), EF, FTM, delayed or arrested maturation rate (DAM), unassisted AVFs and matured AFVs were evaluated. The patients recruited totalled 104, 37 in G1, and 67 in G2. The two groups were homogeneous in age, incidence of diabetes, obesity, heart disease, peripheral vasculopathy, and race. Female were more numerous in G1 (51% vs 12%, p < 0.001). In G1 and G2 occurred respectively 3 IF versus zero (p < 0.05), 10 EF (29%) versus 6 (9%) (p < 0.05), 6 DAM (16%) versus 6 (9%), 21 unassisted AVFs (57%) versus 57 (85%) (p < 0.01). Dividing the patients into groups of unassisted and assisted AVFs, female and low vein diameter are more represented in the assisted group. There were 32 matured AVFs (86%) in G1 and 65 (97%) in G2. In order to increase the incidence of the distal AVF, the PDV allows to include small veins. However, more patients require further interventions to achieve maturation of the fistula.

Emergently Alteration of Procedural Strategy During Transcatheter Aortic Valve Replacement to Prevent Coronary Occlusion: A Case Report.

Background: Coronary occlusion is an uncommon but fatal complication of transcatheter aortic valve replacement (TAVR) with a poor prognosis. Case Presentation: A patient with symptomatic severe bicuspid aortic valve stenosis was admitted to a high-volume center specializing in transfemoral TAVR with self-expanding valves. No anatomical risk factors of coronary occlusion were identified on pre-procedural computed tomography analysis. The patient was scheduled for a transfemoral TAVR with a self-expanding valve. Balloon pre-dilatation prior to prosthesis implantation was routinely used for assessing the supra-annular structure and assessing the risk of coronary occlusion. Immediately after the tubular balloon inflation, fluoroscopy revealed that the right coronary artery was not visible, and the flow in the left coronary artery was reduced. The patient would be at high-risk of coronary occlusion if a long stent self-expanding valve was implanted. Therefore, our heart team decided to suspend the ongoing procedure. A transapical TAVR with a 23 mm J-valve was performed 3 days later. The prosthesis was deployed at a proper position without blocking the coronary ostia and the final fluoroscopy showed normal flow in bilateral coronary arteries with the same filling as preoperatively. Discussion: Our successful case highlights the importance of a comprehensive assessment of coronary risk and a thorough understanding of the TAVR procedure for the heart team. A short-stent prosthesis is feasible for patients at high risk of coronary occlusion. Most importantly TAVR should be called off even if the catheter has been introduced when an extremely high risk of coronary obstruction is identified during the procedure and no solution can be found.

Should we change our carotid stenting technique? Does balloon postdilatation increase periprocedural cranial embolism? A diffusion-weighted magnetic resonance imaging study.

Introduction: Silent cranial embolism has been demonstrated to cause dementia, cognitive decline and even ischemic stroke. Aim: To compare the periprocedural asymptomatic cranial embolism rates of classical carotid artery stenting (CAS) and non-classical CAS methods using cranial diffusion-weighted magnetic resonance imaging (DW-MRI). Material and methods: 367 clinically uncomplicated patients who underwent CAS at our center between December 2010 and June 2020 (mean age: 69.3 ±11.9) were analyzed retrospectively. The patients were divided into 2 groups, classical CAS (130 patients) and non-classical CAS (237 patients). Classical CAS patients were defined as those who received a stent after suboptimal balloon dilatation (with a 3.0-4.0 mm balloon at 8-10 atmosphere (atm)) and underwent balloon postdilatation after stent deployment (with a 5.0-5.5 mm balloon at 8-10 atm). Non-classical CAS patients were defined as those in whom a stent was deployed after optimal balloon dilatation (with a 4.0-5.0 mm balloon at 10-14 atm) and did not undergo balloon postdilatation. Results: Periprocedural asymptomatic ipsilateral microembolism on cranial DW-MRI was detected in 25 (10.5%) patients in the non-classical CAS group and 24 (18.5%) in the classical CAS group. This difference between the two groups was found to be statistically significant (p = 0.033). Conclusions: The rate of ipsilateral asymptomatic cranial embolism detected on cranial DW-MRI was lower in the CAS procedures in which optimal predilatation was performed but postdilatation after stent deployment was not performed compared to the CAS procedures in which suboptimal predilatation and postdilatation after stent deployment were performed.

Effect of direct stenting on microvascular dysfunction during percutaneous coronary intervention in acute myocardial infarction: a randomized pilot study.

OBJECTIVE: Whether direct stenting (DS) without predilatation during primary percutaneous coronary intervention (PPCI) reduces microvascular dysfunction in patients with ST-elevation myocardial infarction is unclear. We performed a randomized study to assess the effect of DS on microvascular reperfusion. METHODS: Seventy-two patients undergoing PPCI were randomly assigned to the DS or conventional stenting (CS) with predilatation groups. The primary endpoint was the post-PPCI index of microcirculatory resistance (IMR). We compared thrombolysis in myocardial infarction myocardial perfusion (TMP) grades, ST-segment resolution, and long-term clinical outcomes between the groups. RESULTS: Microvascular reperfusion parameters immediately after PPCI (e.g., the IMR, TMP grade, and ST-segment resolution) were not different between the groups. However, significantly fewer patients in the DS group had the IMR measured because of no-reflow or cardiogenic shock during PPCI than those in the CS group. No differences were found in left ventricular functional recovery or clinical outcomes between the groups. CONCLUSIONS: This trial showed no effect of DS on the IMR. However, our finding should be interpreted with caution because the number of patients who could not have the IMR measured was higher in the CS group than in the DS group. A larger randomized trial is required (Research Registry number: 8079).

How to create and preserve distal fistulas in a large number of patients: the experience of a single centre.

Background: Distal arterio-venous fistula (AVF) is considered the gold standard for vascular access in hemodialysis. The aim of this retrospective study is to report our experience on two innovative techniques, Intraoperative Transluminal Angioplasty (ITA) and Vessel Pre-Dilatation (VPD). Methods: We collected data from all the consecutive patients directly admitted to our Department from January 2014 to October 2018 in order to create or repair an AVF. Early Failure (EF), Failure to Mature (FTM), Late Failure (LF), Primary and Secondary patency rate were evaluated. Results: All patients underwent VPD; of the total 647 AFVs, 128 received an ITA for the presence of suboptimal vessels. 98.3% of AVFs were located on the forearm. EF occurred in 83 cases; in 67 of these a new AVF was successfully created upstream from the previous one. LF occurred in 100 cases; of these, the access was abandoned in 32 cases and we performed a new AVF upstream from the previous one in 68 cases. FTM occurred in 57 cases, 31 of which were treated with Percutaneous Transluminal Angioplasty (PTA) whilst 26 were resolved performing a new anastomosis upstream. Primary and secondary patency at 1, 2, 3 and 4 years were, respectively, 80%, 74%, 68%, 64% and 94%, 91%, 89%, 88%. By dividing patients into an ITA group and a control group, we did not find any difference in primary and secondary patency. Conclusions: VPD and ITA could be useful to increase the incidence and the prevalence of distal AVF.

Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R).

AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. METHODS AND RESULTS: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). CONCLUSION: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02066623.