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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.

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.

Objectives The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. Background The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. Methods The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. Results After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). Conclusions Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)

The objectives of the study were to evaluate the impact of aortic angulation (AA) on success of transcatheter aortic valve replacement (TAVR) with a new generation self-expandable prosthesis (Medtronic Evolut R®). Specific anatomical conditions, such as for example the presence of a horizontal aorta with elevated AA, have seemed to pose a significant challenge for the correct positioning and consequent functioning of self-expandable TAVR prostheses. We assessed 146 patients treated with Evolut R. AA was measured at computed tomography and two groups were identified using as cutoff the mean AA value. Acute outcomes were collected and compared. AA mean value was 49.6 ± 9.4° (AA ≥ 50°: 76 and AA

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.

Objectives: To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Background: PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. Methods: PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). Results: The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95–0.99], P = 0.002), history of myocardial infarction (2.09 [1.00–4.34], P = 0.049), annulus maximum diameter (0.84 [0.77–0.92], P < 0.001), and THV oversizing (0.90 [0.87–0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23–8.53], P = 0.017 and 5.79[2.33–14.36], P < 0.001). Conclusions: The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

Aims Long-term results of transcatheter aortic valve implantation (TAVI), in particular the incidence of bioprosthetic valve failure (BVF), are uncertain. This study presents data derived from a long-term, structured follow-up programme of the self-expanding CoreValve device utilising standardised definitions and core lab adjudication of valve performance. Methods and results The study prospectively included all 152 patients who had undergone TAVI with the self-expanding CoreValve up to December 2011 at the Heart Center, Bad Segeberg, Germany. Late BVF (>30 days) was defined as either: 1) severe structural valve deterioration (transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation), OR 2) bioprosthetic valve dysfunction leading to death or reintervention. Echocardiographic follow-up at 6.3±1.0 years (range: 5.0-8.9 years) was 88% complete (60 out of 68 survivors beyond five years) and all echocardiograms were analysed by an independent core laboratory. The all-cause mortality rate at 1, 2, 5, 6, 7 and 8 years was 14%, 20%, 50%, 60%, 65%, and 73%, respectively. Among survivors beyond five years, effective orifice area was 1.60±0.46 cm2, and transvalvular mean pressure gradient was 6.7±3.1 mmHg; no cases showed evidence of structural valve deterioration. Five patients (3.3%) had undergone redo TAVI (n=4) or surgery (n=1) 0.6 to 5.2 years after the index procedure, all due to paravalvular leakage. The estimated rate of BVF at eight years was 7.9% for the actuarial and 4.5% for the actual analysis. Conclusions Long-term follow-up up to 8.9 years after TAVI documents favourable performance of the self-expanding CoreValve with low rates of BVF.

Introduction For patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), proper antithrombotic therapy is equivocal. Current guidelines recommend triple therapy, which carries a high risk of bleeding. Recent large trials suggest that dual therapy (DT) with novel oral anticoagulant (NOAC) plus P2Y12 inhibitor can be an appropriate alternative, but real-world data for this alternative are scarce and the optimal duration of DT has not yet been established. Methods This analysis was performed in a single-center prospective cohort. We investigated 216 PCI patients with indication for anticoagulation due to AF. After PCI patients received DT with reduced doses NOAC plus P2Y12 inhibitor for 6 months, which was followed by standard dose NOAC monotherapy. Efficacy endpoints were defined as cardiac death, myocardial infarction (MI), stent thrombosis (ST), and stroke. Safety endpoints were bleeding events as defined by Bleeding Academic Consortium (BARC). Results Baseline characteristics of our study population were described by a CHA2DS2-VASc score of greater than 4 and a HAS-BLED score of greater than 3. After a mean follow-up of 18.7 months, efficacy events occurred in 12 patients (5.6%). We observed three (1.4%) cardiac deaths, two (0.9%) MIs, six (2.8%) strokes, and one (0.5%) definite ST. After switching from DT to NOAC monotherapy after 6.3 ± 1.7 months, there was no rebound of ischemic events. Bleeding events occurred in 34 patients (15.7%) mainly under DT, while bleeding was less during NOAC monotherapy. Conclusions In this long-term study of high-risk and real-world AF-patients with PCI, DT with NOAC and P2Y12 inhibitor (6 months) followed by NOAC monotherapy was safe and effective.

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.

The thick struts of bioresorbable vascular scaffolds (BRS) are associated with changes in wall shear stress and contribute to neointimal proliferation. We aimed to evaluate the relationship between the BRS strut distribution and the neointimal proliferation. 50 lesions underwent optical coherence tomography, 12 months after BRS implantation. Scaffold area and neointimal thickness were evaluated in each cross-sectional area (CSA). Scaffold eccentricity was defined as follows: (maximum diameter − minimum diameter) × 100/maximum diameter. CSAs of BRS were divided into four quadrants. The maximal neointimal thickness (Maximal-NIT), Minimal-NIT and the number of struts in each quadrant were measured. The number of struts were classified as 1, 2, 3 and ≥ 4. Furthermore, the mean-NIT acquired in each quadrant was divided by the average-NIT of all struts in the same CSA, which was defined as the unevenness score. In addition, Maximal-NIT minus Minimal-NIT was divided by the average-NIT of all struts in the same CSA, which was defined as heterogenicity of neointimal proliferation. There was a significant difference in the association between the number of struts and not only the unevenness score (no. of strut = 1 (N = 440), unevenness score 1.04 ± 0.34; 2 (N = 696), 0.98 ± 0.27; 3 (N = 994), 0.96 ± 0.23; ≥4 (N = 1202), 1.04 ± 0.22, P

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

The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years.The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV.The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability.After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cmFive-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).

Aims: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. Methods and results: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, 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

Objectives Percutaneous coronary intervention (PCI) after transcatheter aortic valve implantation (TAVI) can become technically challenging after implantation of the self-expanding Medtronic CoreValve (MCV) device, which completely covers the aortic root. The aim of this study was to report on the incidence, feasibility and outcome of PCI after TAVI with the MCV device. Methods Between 2007 and 2014, all patients subjected to PCI after MCV implantation in a single-center institutional TAVI database were retrospectively identified. Clinical, angiographic and procedural characteristics were reviewed and analyzed. Results We identified a total of 17 patients (5.7%) treated with 24 PCI procedures for 29 lesions at a median of 17.7 months (range 1–72) after MCV implantation. The mean age was 79.7 ± 6.8 years and the mean logistic EuroSCORE was 30.3% ± 18.9%. Nine procedures were performed for patients with acute coronary syndrome. 89.6% of the treated lesions were of type B2/C and 79.3% were de novo ones. A median of one guiding catheter was necessary to intubate the target coronary ostium (range 1–10) and 95% of the lesions on the left coronary artery were treated through a Judkins catheter. In one primary PCI for STEMI the intubation of the right coronary ostium was not successful. Final procedural success was obtained in 95.8%, and peri-procedural death occurred in one patient. Conclusions The need for PCI after MCV is not uncommon and is mostly related to coronary artery disease progression. PCI after MCV is usually feasible and safe, but coronary intubation in an emergency setting can be challenging.

A B S T R A C T Background: Acute kidney injury (AKI) frequently occurs following transcatheter aortic valve implantation (TAVI) and has been related to a worse outcome. We investigated the importance of contrast medium composition, either iso-osmolar (IOCM) or low-osmolar (LOCM) and assessed predictors for AKI after TAVI. Methods and results: We assessed AKI in 203 TAVI patients treated mainly with trans-femoral implantation and analgosedation. A total of 100 patients received IOCM and 103 LOCM. AKI was defined according to the Valve Academic Research Consortium. Following TAVI, 39 patients (19.2%) developed AKI; 17.0% of the IOCM and 21.4% of the LOCM group (p = 0.43). The only independent predictor for AKI was baseline serum creatinine [odds ratio (OR) 0.26, 95% confidence interval (CI) 0.01–0.64, p = 0.002]. Patients with advanced AKI (stages 2 and 3) post-TAVI had significantly higher mortality at 2 years (log rank p < 0.001), whereas patients with AKI stage 1 had a similar long-term outcome to non-AKI patients. Conclusions: Following TAVI, we observed no difference in the occurrence of AKI between IOCM and LOCM. Baseline creatinine was the only independent predictor of AKI, and patients who developed advanced AKI had significantly higher mortality at 2 years.

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.

BACKGROUND The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of\ud device success compared with a self-expandable transcatheter heart valve.\ud OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term\ud follow-up.\ud METHODS The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis\ud and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral\ud transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of\ud clinical outcomes and echocardiographic evaluation of valve function.\ud RESULTS At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval\ud [CI]: 0.73 to 2.50; p ¼ 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p ¼ 0.54) were\ud not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all\ud strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p ¼ 0.11) and repeat hospitalization for heart failure (7.4% vs.\ud 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p ¼ 0.19) did not statistically significantly differ between the 2 groups. Elevated\ud transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%;\ud p ¼ 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular\ud regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p ¼ 0.005).\ud CONCLUSIONS Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients\ud in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis:\ud Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after\ud transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not\ud statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic\ud Stenosis: The CHOICE Trial; NCT01645202) (J Am Coll Cardiol 2015;66:791–800) © 2015 by the American College of\ud Cardiology Foundation.

Transcatheter aortic valve replacement (TAVR) is currently the treatment modality of choice for patients with symptomatic severe aortic stenosis who are inoperable or at high risk for surgical aortic valve replacement. TAVR has shown a clear mortality benefit compared to conservative treatment in inoperable patients and is at least non-inferior to surgical aortic valve replacement in high-risk operable patients. Through improvements in pre-procedural imaging, refinement in valve technologies, increasing operator and team experience, and continuous valuable research, TAVR has developed rapidly in the past few years and is expected to further boost in the near future. In this review, we highlight the current status of TAVR, summarize recent updates, and discuss briefly the future expectations of this rapidly evolving technology.

Transcatheter aortic valve implantation (TAVI) has become the preferred treatment option for patients with symptomatic severe aortic stenosis who are inoperable or at high risk for surgical aortic valve replacement. TAVI has shown a clear mortality benefit compared to conservative treatment in inoperable patients, and is at least non-inferior to surgical aortic valve replacement in high-risk operable patients. Through improvements in the field of imaging, refinement in valve technologies, increasing operator and team experience and continuous valuable research, TAVI has developed rapidly in the past years and is expected to further boost in the near future. In this review, we discuss the technical and procedural aspects of TAVI, the acute and late outcomes, and highlight the current expectations and potential future development of this rapidly evolving technology.

Current guidelines consider severe systolic left ventricular dysfunction [ejection fraction (EF) ≤20 %; left ventricular dysfunction (LVD)] a contraindication for transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the efficacy and safety of TAVI in this extreme risk subset of patients.The study population (253 patients) was divided into two groups; the LVD group [21 patients with left ventricular ejection fraction (LVEF) ≤20 %] and the control group (232 patients with LVEF20 %). TAVI was generally performed transfemorally under analgosedation without mechanical circulatory support. Clinical and hemodynamic variables, as well as procedural and follow-up outcomes, were compared, and all events were defined according to the Valve Academic Research Consortium criteria for event definition. Mean EF in the LVD group was 18.3 ± 2.9 % compared to 50.9 ± 11.3 % in the control group. Patients in the LVD group were younger, more commonly males, had higher logistic EuroSCORE and lower mean aortic pressure gradients. Immediate procedural mortality was low and similar in both groups (0 vs. 2.2 % in the LVD and control group, respectively, p = 0.49). At 30 days, post-procedural vascular and bleeding complications as well as strokes were similar, but all-cause mortality was higher in the LVD group (14.3 vs. 3.4 %, p = 0.05). In the survivors of the LVD group, New York Heart Association functional class and LVEF significantly improved at 30 days and 6 months. Survival at 1 and 2 years was 70.2 vs. 86.0 % and 56.1 vs. 78.3 % in the LVD and control group, respectively (log-rank p = 0.03).TAVI without mechanical circulatory support appears feasible, safe and effective in patients with severe aortic stenosis and severe LVD, but short- and long-term mortality remain high. TAVI should be considered a viable treatment option in this subset of extremely compromised patients.

Objectives This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California). Background AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV. Methods We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score–adjusted models. Results A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p Conclusions More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.

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 impact of different methods of lesion preparation of severely calcified coronary lesions located in a bifurcation is poorly investigated. In the PREPARE CALC trial, patients with severely calcified coronary lesions undergoing percutaneous coronary intervention (PCI) were randomly assigned to

Objectives This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials. Background ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR. Methods A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST). Results Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively. Conclusions Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084 ; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a ‘Real-World’ Patient Population [RINT]; NCT00752128 )

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.

AIMS The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.

Background: Everolimus-eluting bioresorbable scaffolds (BRS) have thick struts, which could influence shear stress and neointimal formation. According to a previous report, the implantation of overlapping BRS has been associated with delayed coverage at 28-days after BRS implantaion. The aim of the present study was to investigate the relationship between BRS overlap and neointimal formation at long-term, using optical coherence tomography (OCT). Method: 32 patients (35 lesions) treated with overlapping BRS underwent follow-up OCT at 11.8±3.0 months after percutaneous coronary intervention. Neointimal area and %uncovered strut were analyzed by OCT at the overlapping BRS site (OBS), non-overlapping proximal and distal BRS sites (NOPBS and NODBS, respectively). Neointimal area was defined as scaffold area - [lumen area + black box (strut)]. %neointimal area was defined as the neointimal areaх100/ scaffold area. In addition, we evaluated the frequency of inter-strut invaginations (hollows) at OBS and non-overlapping sites, which have been suggested as a marker of abnormal vascular reactions to the eluted drug and/or the polymer. Hollows were counted if they exsisted in-between and outside apposed BRS struts. Result: Mean stent diameter and length of overlapped distal BRS and proximal BRS were 2.96±0.39 and 23.1±6.4mm, and 3.11±0.39 and 19.5±6.4mm, respectively. Mean overlap length of BRS was 2.5±1.3mm. At follow-up, %neointimal area was significantly higher at OBS compared to NODBS and NOPBS (35.1±7.8 vs. 20.1±6.2 vs. 21.3±7.6%, respectively, p=0.01). No correlation was observed between the overlap length and %neointimal area. Additionally, %uncovered strut of NODBS and NOPBS was similar to that of OBS. However, the frequency of hollows in OBS was significantly higher than in both NODBS and NOPBS (0.54±0.52 vs. 0.14±0.18 vs. 0.15±0.28/cross-section, respectively, p=0.02). Conclusion: The site of BRS overlap is associated with increased neointimal proliferation one year after implantation, which could be particularly important in patients with small vessels or diffuse coronary disease. Signs of abnormal vascular reactions might be more frequently observed at the site of overlapping BRS compared to non-overlapping site.

Background: Previous studies have described different patterns of neointimal coverage between the outer wall and inner wall at coronary bifurcations lesions (BL) treated with metallic drug-eluting stents (DES) due to endothelial shear stress. Everolimus-eluting bioresorbable scaffolds (BRS) have thicker struts and could therefore have a stronger influence on endothelial shear stress compared to DES. However, the neointimal coverage of BL treated with BRS has not been adequately studied. We sought to evaluate the vascular response to BRS struts deployed at BL using optical coherence tomography (OCT). Methods: 50 patients (64 lesions) underwent follow-up OCT 11.0 ± 2.1 months after BRS implantation. Cross-sectional area of BL with a side branch more than 1mm using OCT was analyzed every 200μm. All images were divided into 3 regions according to shear stress: the 1/2 circumference of the vessel opposite to the ostium (OO), side branch ostium (SO), and the vessel wall adjacent to the ostium (AO). %uncovered strut of all struts and the averaged neointimal thickness (NIT) in 3 regions were evaluated. Additionally, to assess the impact of the side branch size on neointimal proliferation in BL, we calculated the ratio of the diameter of side branch ostium (Ds) to the diameter of main branch (Dm) (Ds/Dm) and divided patients into two groups based on median value of Ds/Dm of 0.318 as follow: large ratio side branch group (LRSB, n=32) and small ratio side branch group (SRSB, n=32). Results: Mean BRS diameter and length were 3.01±0.37 and 20.7±5.5mm. Mean diameter of all side branches was 1.69±0.51mm. In all patients, there was a significant difference in NIT among 3 regions (OO, 121±66 vs. AO, 96±32 vs. SO, 82±43μm, p=0.03). A significant difference was shown in %uncovered strut among 3 regions (OO, 0.45 vs. AO, 1.5 vs. SO, 4.7%, p=0.03). Further, in LRSB group, there was a significant difference in NIT among 3 regions (OO, 130±63 vs. AO, 92±38 vs. SO, 75±39 μm, p=0.01), and a significant difference was shown in %uncovered strut among 3 regions (OO, 0.37 vs. AO, 2.0 vs. SO, 8.8%, p=0.01). Conclusion: Different patterns of neointimal coverage are observed between the outer wall and inner wall of BL treated with BRS. Neointimal coverage is least at and adjacent to large side branches.

Objects: Peri-strut low intensity areas (PLIA) surrounding stent struts on optical coherence tomography (OCT) images has been histologically related to the delayed healing and inflammation, and have been previously associated with neointimal proliferation particularly in first generation drug-eluting stent era. However, the relationship between PLIA and bioresorbable vascular scaffolds (BRS) implantation remains to be clarified. Methods: Of 149 patients treated with the everolimus-eluting BRS at a single institution and followed-up for at least 6 months, 38 patients (50 lesions) underwent follow-up coronary angiography including OCT 11.0 ± 2.1 months after BRS implantation. All patients were prescribed lifelong aspirin (100mg/d) and prasugrel (10mg/d) for at least 6 months. The mean- and percent- neointimal area were evaluated by OCT. PLIA was defined as a peri-strut region with a homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation and was graded as follows:grade 0, no PLIA; grade 1, Results: The frequency of any PLIA within the scaffold segment was 70.0% (35/50 scaffolds). Mean PLIA grade score was 0.72± 0.77 [Median value (interquartile range), 0.51 (0, 1.07)]. There were significant positive correlations between PLIA score and both mean- (R=0.55,p2 , p< 0.01 and 24.0±7.0 vs. 17.4±3.6 %, p< 0.01, respectively).Furthermore, when lesions were divided in 3 groups (group of PLIA score 0, N=15; group of 0< PLIA score, N=15), mean- and percent- neointima area were different among 3 groups (1.51±0.27 vs.1.66±0.39 vs.2.39±0.73 mm 2 , p Conclusion: The presence and extent of PLIA after BRS implantation on OCT imaging appeared to be significantly associated with neointimal formation.

To determine access site related bleeds and vascular complications after access site closure using either the Proglide (PG) or Prostar (PS) suture mediated closure device after transfemoral aortic valve implantation (TAVI). In this large multicenter registry we analyzed a total of 1001 patients

Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed.To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device.The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany.Transfemoral TAVR with a balloon-expandable or self-expandable device.The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications.Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001).Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve.clinicaltrials.gov Identifier: NCT01645202.

This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California).AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV.We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score-adjusted models.A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p0.001).More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.

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.

The optimal treatment approach for coronary intramural hematomas has not been well defined, and discussion is limited to scarce data. In addition, the impact of prior thrombolytic therapy in the setting of coronary artery dissections with possible development and/or extension of an intramural hematoma is not well understood. We describe a case of iatrogenic periprocedural dissection of the left anterior descending artery (LAD) with development of an intramural hematoma and the extension of this hematoma to the left main (LM) and left circumflex (LCX) arteries in a middle-aged female, where prior recent thrombolytic therapy may have played a role in its triggering or facilitation of its extension. This case highlights the importance of facilitation of bleeding complications by prior use of thrombolytic therapy not only peripherally but intracoronary too and the use of intravascular ultrasound for both diagnosis, followup, and percutaneous coronary intervention (PCI) guidance.