Balloon Predilatation Research Articles

Management of acute myocardial infarction occurring during sport practice: Contemporary data from the ‘obseRvatoire des Infarctus de Côte d’Or’ (RICO) survey

Over the last decade, acute myocardial infarction (AMI) management has considerably evolved, but current management of sport-related AMI remains poorly investigated. We aimed to analyze the acute therapeutic strategies used in AMI occurring during sport activity. We retrospectively analyze consecutive patients from an AMI database (RICO survey) who underwent a coronary angiography (CA) in a university hospital after a sport-related AMI within 2011 to 2017 ( n = 100). Most were male (86%), with median age at 58 (50–67) y. Out-of-hospital sudden cardiac arrest (OHSCA) was experienced by 20%; at admission. At the acute phase, 3% underwent ECMO and 2% had an IABP. Intravenous fibrinolysis was given in 14% (26% of the 54 STEMI patients), successfully in 64%. CA was performed through a radial approach in 89%; OCT or IVUS was used in 2 patients. Thromboaspiration was performed in 30%, balloon predilatation in 26% and direct stenting in 73%. Most PCI were performed using drug eluting stent (DES) (69%) with 1 stent (78%), 2 stents (15%), 3 stents (7%) or no stent (5%). Median time from symptoms to reperfusion was 145 (105–228) and to PCI 163 (126–240) min. A re-intervention during hospitalization was performed in 20% of patients, with implantation of 1 stent (39%) 2 stents (35%), 3 stents (17%), 4 stents (4%); all stents but one were DES. Seven patients underwent CABG surgery in addition to PCI. No ICD was implanted. During hospitalization, 10 patients died (all initially presented with OHSCA); all victims treated with ECMO died and only one with IABP survived (used for management of early stent thrombosis). From this large series, thrombolysis was rare, but thromboaspiration was performed in nearly one third of patients; culprit lesions were often treated by direct stenting, with a DES in more than 2/3 of cases. A re-intervention procedure was often needed to treat other lesions, more often with DES rather than CABG.

Abstract 16778: Effectiveness of Platelet Inhibition on Reducing High-Intensity Transient Signals to Cerebral Circulation During Tavi

Introduction: Despite the established dual antiplatelet treatment, embolic cerebrovascular events remain a major concern peri-operatively and following Transcatheter Aortic valve Implantation (TAVI). High Residual Platelet Reactivity (RPR) may contribute to platelet aggregation, propagating thrombosis on implanted materials. Therefore, we evaluated whether high RPR may predispose to an increased number of cerebrovascular emboli during the procedure. Methods: Consecutive patients who underwent transfemoral TAVI with Evolut™ R bioprosthesis were prospectively studied. Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor was administered to all patients 24 hours prior to the procedure at loading dose. The number of detected High Intensity Transient Signals (HITS) was assessed using Rimed Digi-Lite™ Transcranial Doppler on both cerebral arteries during the following phases of the procedure; Phase 0: 30 minutes prior to procedure initiation, Phase I: between access site puncture and introduction of the delivery system, Phase II: during the implantation of the bioprosthesis, until the removal of the delivery system. Platelet inhibition was measured prior to the procedure and expressed in PRU, using the VerifyNow® assay and defined as high RPR if PRU≥208. Results: Out of 28 total patients (81±7 years, 18 males (64%)), 12 patients (81±9 years, 8 males (66.7%)) had PRU ≥208 (high RPR group), while 16 patients (81±5 years, 10 males (62.5%)) had PRU<208 (low RPR group). All device implantations were performed without balloon pre-dilation. Among the high RPR group, a statistically significant higher number of HITS was recorded compared to the low RPR group (707±149 vs. 530±152, p: 0.004). This was mainly driven by the number of HITS detected during Phase II, compared to the rest procedure stages (247±84 vs. 165±28, p:0.004). A statistical significant correlation of PRU with the total number of HITS was found (r2: 0.25, p: 0.006). Conclusions: High RPR after dual antiplatelet loading resulted in larger burden of embolic HITS during TAVI. This may has implications for future strategies for cerebral embolic protection.

PO628 Inoue Balloon Versus Single Balt Balloon Technique In Percutaneous Mitral Balloon Valvuloplasty. Results, In-Hospital Evolution and Cost

In-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT).Patients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD) − follow-up MLD] at 8 months.One hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p = 0.002) and geographical miss (6.9% versus 21.9%, p = 0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17 ± 0.42 mm versus 1.06 ± 0.35 mm, p = 0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85 ± 1.67 mm2 versus 3.81 ± 1.93 mm2, p = 0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78 ± 3.26 mm versus 6.97 ± 4.59 mm, p = 0.04), but average in-segment late loss was similar between the two groups (0.28 ± 0.45 mm versus 0.27 ± 0.38 mm, p = 0.75).Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.

Effect of non-compliant balloon postdilatation on magnesium-based bioresorbable vascular scaffolds.

Optimal implantation results of bioresorbable scaffolds (BRS) are typically assumed to require postdilatation with non-compliant (NC) balloons to achieve full scaffold apposition and minimize event rates. We systematically evaluated the mechanical effect of NC balloon postdilatation on magnesium-based BRS (Magmaris®, Biotronik AG, Bülach, Switzerland) in vivo. In 35 patients, 40 Magmaris® BRS were implanted to treat 37 de novo coronary artery stenoses. A systematic implantation protocol was followed. After appropriately sized NC balloon predilatation (1:1:1 vessel:balloon:scaffold ratio), Magmaris® BRS were implanted with a pressure of 10 atm, followed by NC balloon postdilatation at nominal BRS size (standardized at 16 atm). OCT was performed before and after postdilatation and OCT images were analyzed at a spacing of 0.2 mm to measure BRS dimensions and determine apposition as well as to detect strut fractures. PCI with Magmaris® BRS (mean diameter: 3.21 ± 0.32 mm; mean length: 20 ± 4 mm) was successful in all cases, in one case a non-flow-limiting distal edge dissection occurred after implantation and before postdilatation. NC balloon postdilatation led to significantly larger mean scaffold diameter (3.21 ± 0.32 mm vs. 2.80 ± 0.39 mm, P < 0.001), abluminal scaffold area (7.92 ± 1.43 mm2 vs. 6.72 ± 1.28 mm2 , P < 0.001) and lumen area (7.58 ± 1.1 mm2 vs. 6.83 ± 1.12 mm2 , P < 0.001). Incomplete scaffold apposition area was significantly lower if postdilatation was performed (0.01 ± 0.04 mm2 vs. 0.17 ± 0.11 mm2 , P < 0.001). Strut fractures could neither be observed before nor after postdilatation. NC balloon postdilatation of Magmaris® BRS is required to achieve optimal expansion. It significantly reduces malapposition and can safely be performed without relevant rates of strut fracture.

ACUTE MYOCARDIAL INFARCTION

Objectives: To evaluate the effects of aspiration thrombectomy (AT) using anAspiration Catheter (INVATEC SPA DIVER C.E. MAX, Italy) in patients with acute myocardialinfarction (AMI). Study Design: Cross sectional and Case series study. Setting: Departmentof Cardiology, Liaquat University Hospital, Hyderabad. Period: January 2012 to December2013. Methodology and Results: Measurement of left ventricular ejection fraction (LVEF) byechocardiography was obtained before (acute LVEF) percutaneous coronary intervention (PCI)and 1 week after (late LVEF) the procedure. Most of the patients with full restoration of STsegment elevation following PCI were higher in the aspiration Catheter control group (90 vs68%, P &lt; 0.01), (86 vs 62%, P &lt; 0.01) and (90 vs 64%, P &lt; 0.01) respectively. Minimal changein LVEF was observed in patients between the Aspiration Catheter group and control group at1 week post procedure. Conclusion: Combination of AT using Aspiration Catheter (INVATECSPA DIVER C.E. MAX) with primary stenting can better outcome, while left ventricle (LV) functionhad subtle change in AMI when compared to primary stenting after balloon predilation withoutthrombectomy.

SOCIO-DEMOGRAPHIC FACTORS AND DISEASES CAUSING OVERWEIGHT AND OBESITY AMONG 25-60 YEARS WOMEN IN LAHORE, PAKISTAN

Objectives: To evaluate the effects of aspiration thrombectomy (AT) using anAspiration Catheter (INVATEC SPA DIVER C.E. MAX, Italy) in patients with acute myocardialinfarction (AMI). Study Design: Cross sectional and Case series study. Setting: Departmentof Cardiology, Liaquat University Hospital, Hyderabad. Period: January 2012 to December2013. Methodology and Results: Measurement of left ventricular ejection fraction (LVEF) byechocardiography was obtained before (acute LVEF) percutaneous coronary intervention (PCI)and 1 week after (late LVEF) the procedure. Most of the patients with full restoration of STsegment elevation following PCI were higher in the aspiration Catheter control group (90 vs68%, P &lt; 0.01), (86 vs 62%, P &lt; 0.01) and (90 vs 64%, P &lt; 0.01) respectively. Minimal changein LVEF was observed in patients between the Aspiration Catheter group and control group at1 week post procedure. Conclusion: Combination of AT using Aspiration Catheter (INVATECSPA DIVER C.E. MAX) with primary stenting can better outcome, while left ventricle (LV) functionhad subtle change in AMI when compared to primary stenting after balloon predilation withoutthrombectomy.

Intracoronary Nicorandil and the Prevention of the No-Reflow Phenomenon During Primary Percutaneous Coronary Intervention in Patients with Acute ST-Segment Elevation Myocardial Infarction.

BackgroundThis study aimed to investigate intracoronary nicorandil treatment on the no-reflow phenomenon (NRP) during primary percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) and to compare nicorandil with sodium nitroprusside.Material/MethodsPatients with sustained acute STEMI who underwent primary PCI (N=120) were randomly assigned to three groups: the nicorandil-treated group (N=40) had 2 mg of nicorandil injected into the coronary artery at 2 mm beyond the occlusion with balloon pre-dilation; the sodium nitroprusside-treated group (N=40) underwent the same procedure, but with 200 μg of sodium nitroprusside; the control group (N=40) received PCI and balloon pre-dilation only. Coronary angiography, incidence of NRP, hypotensive episodes, ST-segment resolution (STR) rate, levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase-MB (CK-MB), cardiac troponin I (cTnI), wall motion score index (WMSI), and left ventricular ejection fraction (LVEF) were measured before and after primary PCI. Major adverse cardiovascular events (MACEs) post-PCI and at three-month follow-up were recorded.ResultsPatients in the sodium nitroprusside and nicorandil groups had significantly improved thrombolysis in myocardial infarction (TIMI) scores, TIMI myocardial perfusion grade (TMPG), and ST-segment elevation resolution (STR) (P<0.05), and a significantly lower incidence of NRP (P=0.013). The incidence of intraoperative hypotension in the sodium nitroprusside group was significantly greater than the nicorandil and control groups (P=0.035).ConclusionsPatients with sustained acute STEMI undergoing primary PCI, treated with intracoronary nicorandil had a reduced incidence of the NRP, improved myocardial perfusion and cardiac function.

Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation

Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.

Effect of Selective Thrombus Aspiration on Serum Lipoprotein-Associated Phospholipase A2 in Patients with ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention with High Thrombus Burden.

Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a potential therapeutic target in acute coronary syndromes. Although recent evidence does not support the routine use of manual thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI), the use of TA is associated with a significant improvement in myocardial reperfusion, especially in patients with high thrombus burden (HTB). We hypothesized that TA would reduce the serum Lp-PLA2 levels in STEMI patients undergoing PPCI with HTB. Our study cohort included 320 consecutive STEMI patients undergoing PPCI with HTB who were randomly assigned to receive either TA before PPCI (TA group, n = 160) or PPCI alone (standard PPCI group, n = 160). The baseline characteristics of study participants were well-matched. After 30 ± 2 days, serum Lp-PLA2 levels decreased by 53.9% in the TA group (152.9 ± 58.1 ng/mL) and decreased by 31.2% in the standard PPCI group (84.2 ± 86.6 ng/mL, p < 0.001). The TA group had a significantly lower prevalence of balloon predilatation, number of stents used, total stent length and corrected thrombolysis in myocardial infarction frame count, and a higher percentage of myocardial blush grade ≥ 2 compared with the standard PPCI group (all p < 0.001). No significant difference between the groups was observed in 30 ± 2 days for major adverse cardiovascular and cerebrovascular events (p = 0.702). After 30 ± 2 days of treatment, TA may significantly reduce serum levels of Lp-PLA2 in STEMI patients undergoing PPCI with HTB.

Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.

PRIOR BALLOON VALVULOPLASTY VERSUS DIRECT TRANSCATHETER AORTIC VALVE IMPLANTATION (DIRECTAVI): PRELIMINARY FINDINGS ON THE FIRST 128 RANDOMIZED PATIENTS

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure but recent evidence has suggested that aortic valvuloplasty may induce complications. The purpose of the DIRECTAVI study was to evaluate the efficacy

Treatment with 48-mm everolimus-eluting stents : Procedural safety and 12-month patient outcome.

Lesion length is amajor predictor of adverse outcomes after percutaneous coronary intervention. Long lesions often require multiple stents with variable overlap, which increases the probability of geographical miss and the incidence of mechanical complications, such as side-branch occlusion, restenosis, and stent thrombosis. These pitfalls may be avoided by use of an ultra-long device. We retrospectively assessed the performance of the 48-mm Xience Xpedition everolimus-eluting stent (EES) at our institution. Atotal of 123 patients (mean age: 60.94years, n= 93 [76%] male) with 129 lesions were identified. Lesions (n= 69, 53.5%) were located in the left anterior descending artery, the right coronary artery (n= 47, 36.4%), and the circumflex artery (n= 8, 6.2%); 83 lesions involved amajor side branch. The majority were treated with aprovisional single-stent strategy. Other characteristics included significant tortuosity in 15lesions (11.6%) and moderate-to-heavy calcification in 46lesions (35.7%). In all cases, balloon pre-dilatation was performed before stent insertion. Successful delivery and deployment of the 48-mm EES device was achieved in 100% of the patients. The mean number of stents per lesion was 1.4, while the mean total stent length was 58± 17.3 mm and mean stent diameter, 3.00± 0.67 mm. The procedural success rate was 99.2%. The 30-day major cardiac adverse event (MACE) rate was 0.8%, while the 12-month MACE was 3.3%. The Xience 48-mm EES device appears to be safe and efficacious with alow clinical event rate at the 12-month follow-up. Where feasible, this would support the use of the ultra-long 48-mm platform in lieu of multiple overlapping shorter devices.

TCT-303 Balloon Predilation in Transcatheter Aortic Valve Replacement with Self-Expanding Valves

TCT-303 Balloon Predilation in Transcatheter Aortic Valve Replacement with Self-Expanding Valves

Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial

ObjectivesThe aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis. BackgroundDCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy. MethodsIn this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year. ResultsFollow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year. ConclusionsIn patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371)

Implantation of stents for postsurgical recoarctation of the aorta in adolescents and adults.

Results of stent implantation (SI) of postsurgical recoarctation of the aorta (ReCoA) are not frequently published. This study sought to retrospectively evaluate results of SI in ReCoA in older children and adults. Twenty-eight SIs were performed on 26 ReCoA patients with a median age of 23 (10-65) years. Dependent upon availability, the following stents were applied: Palmaz, Cheatham Platinum (CP), Andrastents XL/XXL (AS), Covered CP (CVCP) stents, and self-expanding stents (Smart). Generally, high-pressure balloons were applied to dilate stents. The procedure was effective in 20/26 patients (77.7%). The mean peak systolic gradient reduced from 40.5 ± 18.7 mm Hg to 13.1 ± 12.1 mm Hg (p < 0.05), and the diameter of the stenosed segment increased from 7.5 ± 3.02 mm to 13.1 ± 3.32 mm (p < 0.05). In six cases (including a patient treated with a Smart stent) transaortic pressure gradient after SI remained > 20 mm Hg (stiff postsurgical lesion). For one patient (40-year-old male), an acute dissection of the aorta occurred during balloon predilatation. Immediate CVCP implantation resolved this problem. Two more CVCPs were used - one to close a small aortic aneurysm that appeared five years after a Palmaz SI and another to stabilise a broken CP bare metal stent. There were no deaths or aortic dissections during follow-up, and most patients were able to reduce or suspend their medication for systemic hypertension. Endovascular stenting of ReCoA in adults and adolescents appears to be an acceptable method of treatment in experienced hands. However, for some patients the presence of a stiff lesion can provoke suboptimal results. Considering the serious complications that can occur after SI, all patients should have regular follow-up (including an imaging study). Covered stents should always be available in the cathlab as a rescue device when implanting stents in coarctation of the aorta patients.

Effect of transcatheter embolization by tissue adhesive Histoacryl in treatment of coronary artery perforation during percutaneous coronary intervention

Aim. Coronary artery perforation (CAP) is a rare but severe complication of percutaneous coronary intervention (PCI). The aim of our study was to evaluate the effect and safety of transcatheter embolization by tissue adhesive Histoacryl when treating CAP.Methods. As CAP was confirmed, the final composition of the tissue adhesive histoacryl and radiopaque agent Lipiodol was prepared. The perforated vessel was embolized by tissue adhesive Histoacryl via a micro-catheter. There were eleven patients undergoing transcatheter embolization by Histoacryl in treatment of CAP during PCI at Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology from March 2013 to February 2016, and the clinical data of these patients were collected and analyzed retrospectively.Results. The lesion morphology of the patients was classified by using the American College of Cardiology/American Heart Association Task Force classification, there were four patients with Class B2 lesions and seven patients with Class C lesions (there also were four patients with chronic total occlusion lesions). According to the Ellis classification of CAP, there were five patients with Class II perforations and six patients with Class III perforations. The causes of perforation were a guide wire (ten patients) and balloon predilation (one patient). Three patients had pericardial effusion. All of the eight patients with CAP underwent transcatheter embolization by Histoacryl. Coronary angiography confirmed that all of them had been embolized successfully. There were no severe postoperative complications. Conclusion. Transcatheter embolization by Histoacryl is an effective, safe, cheap, and easy way to treat perforation of small vessels during PCI.Received 14 September 2016. Accepted 2 February 2017.Financing: The study did not have sponsorship.Conflict of interest: Conflict of interest: Evgeny I. Kretov served as guest editor on this issue on vascular surgery. The other authors declare no conflict of interest.Author contributionsData collection and analysis: Shermuk A.A., Naryshkin I.A., Grankin D.S., Zubarev D.D., Ibragimov R.U., Baystrukov V.I. Drafting the article: Shermuk A.A., Khelimskiy D.A., Krestyaninov O.V. Critical revision: Shermuk A.A., Khelimskiy D.A., Krestyaninov O.V., Kretov E.I.

Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: A systematic review and meta‐analysis

To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta-analysis of available evidence. Avoiding BPD during TAVR was shown to be feasible in previous studies but the risks and benefits of this technique are unknown owing to the limited number of patients included in these studies. We performed a systematic search for studies comparing direct TAVR vs TAVR performed with BPD. Crude risk ratios (RRs) or mean differences and 95% confidence intervals (CI) for each endpoint were calculated using random effects models. Twenty studies including 3586 patients (1606 undergoing direct TAVR) were selected for the analysis. Mean device success with direct TAVR was 88% with <5% of bail-out techniques. There were no differences between direct and BPD-TAVR in short-term (in-hospital or 30-day) mortality (RR: 1.06; 95% CI: 0.78-1.43) or cerebrovascular events (RR: 0.92; 95% CI: 0.58-1.46). Direct TAVR associated with reduced moderate or severe paravalvular leak post-TAVR (RR: 0.59; 95% CI: 0.36-0.98) but not with a reduced risk of permanent pacemaker implantation (RR: 0.85, 95% CI: 0.71-1.02). A slight increase in postdilation was observed in direct transfemoral-TAVR recipients (RR: 1.2; 95% CI: 1.00-1.44). Direct TAVR is feasible and safe. However, given the unadjusted nature of our results, uncertainties remain regarding the independent effect of direct TAVR on outcomes post-TAVR. Randomized studies are warranted to determine the potential benefits of direct TAVR. © 2017 Wiley Periodicals, Inc.

IMPACT OF BALLOON PRE-DILATATION ON HEMODYNAMICS AND CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE SELF-EXPANDING COREVALVE PROSTHESIS

Background: The Pivotal trials of transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve (CV) prosthesis mandated balloon pre-dilatation (BPD) for every patient. Since then, use of BPD has steadily fallen. However, the impact of BPD on prosthesis hemodynamics and clinical

First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†.

: The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV. : A consecutive patient series received direct transfemoral (TF)-TAVI without prior BAV using the Lotus™ valve system. Baseline, intraprocedural and acute follow-up data up to 30 days were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized Valve Academic Research Consortium (VARC)-2 definitions. : A total of 9 patients received direct TF-TAVI using the Lotus THV (77.7% female, 82.5 ± 5.3 years, logistic European System for Cardiac Operative Risk Evaluation I 14.2 ± 13.7%). Device success according to VARC-2 definitions was achieved in 100% (9/9) of the patients. Peak and mean transvalvular gradients as determined by transthoracic echocardiography prior to discharge decreased from 51.5 ± 17.3 to 24.4 ± 10.4 mmHg and 29.5 ± 9.6 to 13.2 ± 5.2 mmHg (both P < 0.01). Effective orifice area increased from 0.9 ± 0.2 to 1.9 ± 0.3 cm 2 ( P < 0.01). No paravalvular leakage (PVL) ≥ moderate was detected. All-cause 30-day mortality was 11.1% (1/9), with one death due to ischaemic enteritis. : In our series, TF-TAVI without prior BAV using this particular THV technical feasibility, no increased incidence of significant paravalvular leakage, and good haemodynamic and clinical outcome in selected patients. These results will have to be confirmed in larger patient numbers for further clinical evaluation and before general recommendations regarding patient selection can be made.

Balloon dilatation and outcome among patients undergoing trans-femoral aortic valve replacement

BackgroundBalloon pre-dilatation before transcatheter aortic valve replacement (TAVR) is performed at the discretion of the treating physician. Clinical data assessing the implications of this step on procedural outcomes are limited. MethodsWe conducted a retrospective analysis of 1164 consecutive TAVR patients in the Israeli multicenter TAVR registry (Sheba, Rabin, and Tel Aviv Medical Centers) between the years 2008 and 2014. Patients were divided to those who underwent balloon pre-dilation (n=1026) versus those who did not (n=138). ResultsRates of balloon pre-dilation decreased from 95% in 2008–2011 to 59% in 2014 (p for trend=0.002). Baseline characteristics between groups were similar except for more smoking (22% vs. 8%, p=0.008), less past CABG (18% vs. 26%, p=0.016), less diabetes mellitus (35% vs. 45%, p=0.01), and lower STS mortality scores (5.2±3.7 vs. 6.1±3.5, p=0.006) in the pre-dilatation group. The pre-dilation group included less patients with moderate to severely depressed LVEF (7% vs. 16%, p<0.001) and higher aortic peak gradients (76.9±22.7mmHg vs. 71.4±24.3mmHg, p=0.01). Stroke rates were comparable in both groups (2.5% vs. 3%, p=0.8), but pre-dilation was associated with lower rates of balloon post-dilatation (9% vs. 26%, p<0.001). On multivariate analysis, balloon pre-dilatation was not a predictor of device success or any post-procedural complications (p=0.07). ConclusionsBalloon pre-dilatation was not associated with procedural adverse events and may decrease the need for balloon post-dilatation. The results of the present study support the current practice to perform liberally balloon pre-dilatation prior to valve implantation.