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The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.

In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA.Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months.In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; pIn patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.

BACKGROUND: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. AIMS: We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon. METHODS: In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon. CONCLUSIONS: In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. VISUAL SUMMARY: A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4–43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE–CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions. Graphical abstract

Objectives. To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. Background. The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. Methods. We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow p = 0.82 ), and a two-stent technique was performed in 21.3% vs. 25% ( p = 0.75 ). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group ( p = 0.001 ). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p = 0.02 ). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. Conclusions. In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.

Background Calcified coronary lesions present therapeutic challenges for the interventional cardiologist, often requiring rotational atherectomy (RA). Aims This study aimed to develop an angiographic scoring tool to predict the need for a priori RA. Methods A pooled analysis of the randomised ROTAXUS and PREPARE-CALC studies was carried out, (N=220 patients, N=313 lesions), by virtue of the fact that both studies made provision for crossover to RA (from balloon dilatation or modified balloon dilatation, respectively). Logistical regression techniques were employed to assess for the presence of patient- or lesion-specific factors leading to a necessity for RA. External validation was performed though retrospective calculation of the score for 192 patients who underwent bail-out RA in a single centre. Results Lesion length (odds ratio [OR] 1.02, 95% confidence interval [CI]: 1.00-1.04 per mm, p=0.04), bifurcation lesion (OR 2.60, 95% CI: 1.27-5.30, p=0.009), vessel tortuosity g45° (OR 3.49, 95% CI: 1.73-7.03, pl0.001) and severe vessel calcification (OR 11.60, 95% CI: 3.40-39.64, pl0.001) were predictive of the need for RA in multivariate analysis. Based on the regression coefficients, a scoring system was devised. The greater the score, the more likely a lesion required RA. The scoring system performed well in the external validation cohort, with 78% of patients crossing over having a score of greater than the proposed cut-off of 3. Conclusions We provide an angiographic scoring tool to support the expeditious use of time and resources, allowing assessment of the likelihood of success of a balloon-based strategy, or the necessity for RA.

Objectives The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli. Background The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs. Methods Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli. Results THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR. Conclusions Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.

Background: Percutaneous intervention of calcified coronary lesions often requires lesion preparation with either balloon dilatation or atherectomy. We sought to evaluate the impact of lesion preparation strategy on stent expansion following preparation of severely calcified coronary lesions with modified (cutting/scoring) balloons (MB) versus rotational atherectomy (RA) and to evaluate the impact of calcium burden as assessed by optical coherence tomography (OCT) on acute stent performance. Methods: In the PREPARE-CALC trial (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions), 200 patients with severely calcified coronary lesions were randomly assigned to receive either lesion preparation with MB or RA. In 122 patients, OCT was performed before lesion preparation and at the end of the procedure. The principal end point of this OCT sub-analysis was stent expansion as assessed by OCT. The key secondary end points included stent asymmetry and eccentricity. Results: The maximal calcific arc (257.5±96.7° versus 248.7±82.1°, P =0.59), thickness (1.34±0.29 versus 1.32±0.27 mm, P =0.76), and length of calcification (21.1±9.7 versus 24.0±10.9 mm, P =0.12) did not differ between the MB versus RA group. Lesion preparation with MB versus RA lead to comparable stent expansion (73.5±13.3% versus 73.1±12.2%, respectively, P =0.85). The use of RA did not have a significant impact on stent asymmetry or eccentricity compared with the use of MB. Length of calcified plaque appeared to be increased in patients with stent underexpansion, while thickness of calcified plaque was increased in patients with stent asymmetry. Target lesion revascularization at 9 months was 3.3% when MB was used and 1.6% when RA was performed ( P =0.62). Conclusions: In this OCT sub-analysis from the PREPARE-CALC trial, calcified plaque length was increased in patients with stent underexpansion, while its thickness was higher in patients with stent asymmetry, with no impact of the lesion preparation strategy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02502851.

Background Incomplete stent apposition (ISA) can be divided into acute and late forms. Late ISA may be due to persistent ISA or late-acquired ISA (LAISA). This study evaluated the natural course of ISA after bioresorbable vascular scaffold (BRS) implantation using optical coherence tomography (OCT). Methods Thirty-two patients (45 BRS) were assessed immediately after BRS implantation and 1 year thereafter using OCT. Acute ISA identified after BRS implantation but absent at follow-up was defined as resolved; otherwise, it was considered persistent. LAISA was defined as newly developed ISA that was identified at follow-up despite complete apposition immediately after BRS implantation. Intra-BRS fibrin-like material (IBF) was identified as an irregular intraluminal mass. ISA percentage was expressed as follows: (number of ISA/total number of BRS struts) × 100. Results Among 45 BRS and 15,894 analyzed BRS struts, 34 and 882 had acute ISA post-procedure, respectively. At follow-up, 92 of 15,364 analyzed struts exhibited late ISA (64 persistent ISA and 28 LAISA). In 15 of 28 struts with LAISA, LAISA occurred at the sites adjacent to post-interventional dissection. Uncovered struts were more frequently observed in late ISA compared to apposed struts (3.7 ± 4.8 vs. 0.58 ± 2.2%, p = 0.09). IBF was significantly more common in BRS with late ISA (62.5 vs. 8.1%, p = 0.02). Receiver-operating characteristic curve analysis identified a cut-off value of 280 μm for acute ISA distance predicting persistent ISA. Conclusion Resolution of acute ISA after BRS is common. The occurrence of LAISA may be infrequent and may be a nidus of stent thrombosis.

Peri-strut low intensity areas (PLIA) surrounding metallic coronary stent struts on optical coherence tomography (OCT) images have been histologically related to delayed healing and inflammation, and have been associated with neointimal proliferation. The relationship between PLIA and vascular healing response after bioresorbable scaffold (BRS) implantation remains unclear.This study includes 38 consecutive patients (50 scaffolds) evaluated using OCT 12 months after BRS implantation. Mean and percent neointimal area were quantified. A PLIA was defined as a peri-strut region with an homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation. Cross sections were scored as follows: score 0, no PLIA; score 1,1 quadrant; score 2, ≥1 but2 quadrants; score 3, ≥2 quadrants but3 quadrants; and score 4, ≥3 quadrants. Scaffolds were divided into two groups (PLIA+ and PLIA-) based on the presence or absence of any PLIA in the scaffold segment.The frequency of any PLIA within the scaffold segment was 70.0%. The median PLIA score per scaffold was 0.51 (interquartile range 0-1.07). Using both scaffold- and frame-level analysis, a significant positive correlation was observed between PLIA score and both mean and percent neointimal area. Mean and percent neointimal area were significantly higher in the PLIA+ group than in the PLIA- group (1.95±0.65mmThe presence and extent of PLIA on OCT imaging after BRS implantation appears to be significantly associated with neointimal formation.

Objectives: The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.Background...

AIMS The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. METHODS AND RESULTS This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p

A 56-year-old woman underwent an emergent pericardial window procedure for recurrent pericardial effusion with tamponade. An arterial line for invasive blood pressure monitoring was inserted in the left femoral artery. Because of hemodynamic instability, a venoarterial extracorporeal membrane

A 76-year-old female patient underwent transcatheter aortic valve replacement for severe aortic valve stenosis. The left common femoral artery (CFA) was used for angiography, and the right CFA was used for large-bore access. The right CFA was punctured under road-map guidance, and a 14-Fr sheath was

Objectives The aim of this study was to compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of calcified coronary lesions. Background Current guidelines recommend RA as a bailout procedure for calcified or fibrotic lesions that cannot be adequately dilated before stenting. Nonetheless, planned RA is sometimes performed in certain challenging anatomies. Methods Data of patients treated with RA between 2002 and 2014 at a single-center registry were retrospectively analyzed. The bailout RA group included patients where RA was employed after failure of balloon dilatation or stent delivery. Planned RA included patients where RA was employed electively without previous device failure. Results The study comprised 204 patients (221 lesions) and 308 patients (338 lesions) treated with bailout or planned RA, respectively. Angiographic success was achieved in the majority of cases, but was lower in the bailout RA group (93.7% vs. 97.6%, P = 0.02). Coronary dissections occurred more frequently in the bailout RA group (8.6% vs. 4.4%, P = 0.04), mean contrast amount was higher (279 ± 135 mL vs. 202 ± 92 mL, P

This study investigated the predictors of acute recoil after implantation of everolimus-eluting BRS based on optical coherence tomography (OCT). Thirty-nine patients (56 scaffolds) were enrolled. Acute absolute recoil by quantitative coronary angiography was defined as the difference between the mean diameter of the last inflated balloon (X) and the mean lumen diameter of BRS immediately after balloon deflation (Y). Acute percent recoil was defined as (X − Y) × 100/X. Plaque eccentricity (PE) and plaque composition (PC) were assessed by OCT. PC was classified into two different types: calcific (score = 1), fibrous and lipid (score = 0). Based on the mean acute scaffold recoil value of the present study, scaffolds were divided into two groups: the low acute recoil group (LAR, n = 34) and the high acute recoil group (HAR, n = 22). Acute percent and absolute recoil were 6.4 ± 3.0 % and 0.19 ± 0.11 mm. PE, PC score and scaffold/artery ratio were significantly higher in HAR than in LAR. In multivariate logistic regression analysis, PE > 1.49, PC score (score 1) and scaffold/artery ratio >1.07 were significant positive predictors for the occurrence of acute scaffold recoil (OR 10.7, 95 % CI 2.2–51.4, p

Heterogeneity of neointimal thickness is observed after drug-eluting stents implantation in bifurcation lesions (BL). We evaluated the vascular response of everolimus-eluting bioresorbable scaffold (BRS) struts deployed at BL using optical coherence tomography (OCT). 50 patients (64 scaffolds) underwent follow-up OCT after BRS implantation. Cross-sectional areas of each BL with a side branch more than 1.5 mm were analyzed using OCT every 200 µm. All images were divided into three regions according to shear stress: the 1/2 circumference of the vessel opposite to the ostium (OO), the vessel wall adjacent to the ostium (AO) and the side-branch ostium (SO). The %uncovered strut and the averaged neointimal thickness (NIT) were calculated. Overall, there were significant differences in both NIT and %uncovered strut among the three regions (OO, 119.2 ± 68.5 μm vs. AO, 94.2 ± 35.7 μm vs. SO, 80.5 ± 41.4 μm, p = 0.03; OO, 0.4 %vs. AO, 1.4 %vs. SO, 4.8 %, p = 0.02). Scaffolds were divided into two groups: a large-ratio side-branch group (LRSB; n = 32) and a small-ratio side-branch group (SRSB; n = 32), based on the median value of the ratio of the diameter of side branch ostium (Ds) to that of the main branch (Dm). In the LRSB alone, there were significant differences in both NIT and %uncovered strut among the three regions (OO, 128.0 ± 61.1 μm vs. AO, 97.3 ± 34.3 μm vs. SO, 75.9 ± 39.4 μm, p

Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined.We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups.Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months.URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

Background: Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. Methods and Results: We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of P =0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P =0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P =0.21, P =0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P =0.17), definite or probable stent thrombosis (0% versus 0%; P =1.00), and target vessel failure (8% versus 6%; P =0.78) were low and not significantly different between the MB and RA groups. Conclusions: Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli.The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs.Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (23 mm) or small (≤23 mm) annuli.THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR.Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.

Criteria for elective rotational atherectomy (RA) are poorly defined, and upfront procedures are usually performed based on operator’s preference and experience. We sought to identify clinical and angiographic factors associated with the need for bailout RA in patients with calcified coronary

The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.Limited data exists on clinical or manifest transcatheter heart valve thrombosis. Prior studies have focused on subclinical thrombosis.A retrospective analysis was conducted of prospectively collected data from a single-center registry that included 642 consecutive patients who underwent transcatheter aortic valve replacement between 2007 and 2015 (305 patients had self-expanding valves; balloon-expandable, n = 281; mechanically expanding, n = 56). Long-term oral anticoagulation (OAC) was indicated in 261 patients, while 377 patients received dual-antiplatelet therapy post-procedure. All patients underwent scheduled clinical and echocardiographic follow-up.The overall incidence of clinical valve thrombosis was 2.8% (n = 18). No patient on OAC developed thrombosis. Of the detected thrombosis cases, 13 patients had balloon-expandable, 3 had self-expanding, and 2 had mechanically expanding valves. Thrombosis occurred significantly more often with balloon-expandable valves (odds ratio: 3.45; 95% confidence interval: 1.22 to 9.81; p = 0.01) and following valve-in-valve procedures (odds ratio: 5.93; 95% confidence interval: 2.01 to 17.51; p = 0.005). Median time to diagnosis of valve thrombosis was 181 days. The median N-terminal pro-brain natriuretic peptide level was 1,318 pg/ml (interquartile range: 606 to 1,676 pg/ml). The mean transvalvular gradient and valve area were 34 ± 14 mm Hg and 1.0 ± 0.46 cmClinical transcatheter heart valve thrombosis is more common than previously considered, characterized by imaging abnormalities and increased gradients and N-terminal pro-brain natriuretic peptide levels. It occurred more commonly after balloon-expandable transcatheter aortic valve replacement and valve-in-valve procedures. OAC appeared to be effective in the prevention and treatment of valve thrombosis. Randomized control trials are needed to define optimal antithrombotic therapy after transcatheter aortic valve replacement.

Rotational atherectomy has been regaining interest over the last couple of years after it almost has disappeared from most interventional catheterization laboratories for several years due to failure to prove its original concept of improving long term results of percutaneous coronary interventions (PCI) as was repeatedly shown in studies in the 1990s. Its revival coupled the introduction of drug-eluting stents (DES); these devices have led to treating much more complex lesions and high-risk patients by PCI. However, real-world experience suggested that off-label use of DES is associated with a higher rate of early and late stent thrombosis. Therefore, more attention is now being paid to the initial implantation technique of DES including aggressive lesion preparation to facilitate stent delivery and expansion. The limited studies with rot-ablation and DES showed promising results with no long term safety concerns. In these studies, a subtle observation was made suggesting that rot-ablation prior to DES implantation in such lesions may have an add-on effect on long term outcome compared to DES alone. An ongoing multicenter study is investigating such effect among complex calcified coronary lesions. Even if this additive benefit does not prove true, rot-ablation remains an efficient tool for preparing certain lesions to facilitate effective and safe DES implantation. Therefore, interventional training programs should focus on this difficult technique to bridge the gap of experience which resulted from neglecting it for several years. In this regard, dedicated courses at experienced sites as well as medical simulation may be appropriate.

Background Certain patients with complex calcified left main (LM) disease have a prohibitive risk for bypass surgery. Rotational atherectomy (RA) prior to stent implantation is an option for this subset of patients. Objective To analyze acute and long-term results of RA in the LM location. Methods We present a single-center analysis of RA in severe LM disease applied in patients with high surgical risk. Results RA was performed in the LM location in 50 consecutive patients with a mean age of 73years. In 30% of the patients clinical presentation was an acute coronary syndrome, and 42% had diabetes. LM bifurcation was involved in 80% of the cases, 36% had a Medina class 1.1.1 lesion, and 38% of RA procedures were performed as bailout. In 38% of patients the left main was protected. Median logistic EuroSCORE was 12.4% (interquartile range, IQR, 5.24–36.11%) and mean SYNTAX Score was 28.6±8.2. The median burr size was 1.5mm and a two-stent strategy was required in 58% of interventions. Drug-eluting stents were implanted in 86% of procedures. Angiographic success rate was 96%, and in-hospital major adverse cardiac event rate was 10%. Survival free of cardiac death at 12 and 24months was 87.6% and 78.4%. Target lesion revascularization rates (TLR) were 13.3% and 18.8%, respectively. Cardiac deaths were significantly higher in patients with acute coronary syndromes compared with patients with stable angina (cardiac death free survival was 72.7% and 94% at 12months, p=0.01). The TLR rate was numerically higher in diabetic patients (21.1% vs. 7.7% at one year, p=0.18). Conclusion Acute and long-term outcomes after LM rotational atherectomy are satisfactory, considering the high procedure- and patient-related risks.

Aims Rotational atherectomy (RA) is frequently performed to modify complex fibrocalcific coronary lesions with high procedural success. A stuck rotablator is a rare but life-threatening complication. However, its description remains sporadic and it has never been systematically analysed. The aim of this analysis is to present our experience and summarise the available literature about stuck rotablator, and to identify risk factors and possible management strategies for this complication. Methods and results We analysed our experience of 442 RA procedures and identified four cases of stuck rotablator. Two of these cases were rotablations in freshly implanted stents. All cases were managed percutaneously. We further analysed the available literature and identified a total of 11 reports with 14 cases of a stuck rotablator burr; seven were managed surgically and seven with endovascular approaches. Based on our experience and the literature review we developed an algorithm to guide operators while managing this complication. Conclusions Entrapment of a rotablation burr is a rare but very serious complication of RA. Operators performing RA should be aware of this risk and be prepared to manage it adequately. In our experience, the risk seems to be higher when rotablating freshly implanted underexpanded stents.

The optimal antithrombotic treatment for patients on oral anticoagulants (OAC) undergoing percutaneous coronary intervention (PCI) is controversial. We analyzed the safety and efficacy of dual therapy with OAC plus clopidogrel in atrial fibrillation (AF) patients receiving drug-eluting stents (DES). In this retrospective analysis, all AF patients treated with dual therapy were retrospectively identified. Efficacy endpoints included cardiac death, myocardial infarction (MI), stent thrombosis (ST) and cerebrovascular stroke at follow-up, while safety was assessed by bleeding events defined by the Bleeding Academic Research Consortium (BARC). Between January 2008 and August 2010, 221 patients with high-risk AF received a DES and a dual therapy with OAC and clopidogrel. At a mean follow-up of 19 months, bleeding complications occurred in 22 patients (10 %), more than half of them (n = 12) were related to the index PCI. We observed 11 cardiac deaths (4.9 %), 9 MIs (4.1 %), 3 definite (1.4 %) and no probable ST at follow-up. All definite ST occurred after cessation of clopidogrel at 8, 22, and 30 months after PCI in patients not adequately anticoagulated. Eight patients (3.6 %) had an ischemic stroke, five of which after temporary or permanent cessation of OAC. The data generated from this large single-center experience in AF patients treated with DES revealed that dual therapy with OAC plus clopidogrel for 6–12 months followed by monotherapy with OAC appears both safe and effective at long-term follow-up. However, after clopidogrel cessation, maintaining therapeutic anticoagulation with an INR >2 is essential to prevent both thrombotic and embolic events.

To report clinical experience with longitudinal stent deformation (LSD) and observations from the bench. LSD was recently reported with thin-strut coronary stents. Whether it is related to a particular stent or constitutes a class-effect remains debatable.After 2 cases of LSD were reported, information was sent to operators to warn of this event and identify possible cases. All cases were reviewed to ensure LSD had occurred. Simultaneously, bench testing was conducted to identify the susceptibility of stents to longitudinal compression and whether LSD detection is influenced by fluoroscopic stent visibility. Between July 2010 and November 2011, 2,705 coronary interventions were performed with 4,588 stents (Promus Element = 41.6%, Xience Prime = 24.4%). Six patients with LSD were identified, all with Promus Element (0.31%). Wire bias was a predisposing factor in 4 cases. All patients were treated with postdilatation and/or additional stenting. No adverse events occurred (mean 5.8 months). In bench testing, LSD occured in all examined stents, but at different levels of applied force (weight). Most shortening at 50 g was observed with Promus Element (38.9%), as was the best visibility of LSD on x-ray images. With postdilatation all stents showed some re-elongation.In our practice LSD was a rare observation only seen with the Promus Element stent. When subjected to longitudinal compression in a bench test all contemporary stents can be compressed. Compression of Promus Element occurs at a lower force, but it is the only stent where deformations are detected with x ray. Postdilatation can partially improve LSD.

Percutaneous coronary intervention (PCI) of moderate and severely calcified lesions has been described as a predictor of worse outcomes when bare-metal stents or first-generation drug-eluting stents (DES) have been used. Little is known about the impact of coronary calcification on outcome after PCI