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Background: The real-world outcomes of the use of the BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) transcatheter technique in Europe have not been described., Aims: We sought to evaluate the procedural and one-year outcomes of BASILICA in patients at high risk for coronary artery obstruction (CAO) undergoing transcatheter aortic valve implantation (TAVI) in a multicentre European registry (EURO-BASILICA)., Methods: Seventy-six patients undergoing BASILICA and TAVI at ten European centres were included. Eighty-five leaflets were identified as targets for BASILICA due to high risk for CAO. The updated Valve Academic Research Consortium 3 (VARC-3) definitions were used to determine prespecified endpoints of technical and procedural success and adverse events up to one year., Results: Treated aortic valves included native (5.3%), surgical bioprosthetic (92.1%) and transcatheter valves (2.6%). Double BASILICA (for both left and right coronary cusps) was performed in 11.8% of patients. Technical success with BASILICA was achieved in 97.7% and resulted in freedom from any target leaflet-related CAO in 90.6% with a low rate of complete CAO (2.4%). Target leaflet-related CAO occurred significantly more often in older and stentless bioprosthetic valves and with higher implantation levels of transcatheter heart valves. Procedural success was 88.2%, and freedom from VARC-3-defined early safety endpoints was 79.0%. One-year survival was 84.2%; 90.5% of patients were in New York Heart Association Functional Class I/II., Conclusions: EURO-BASILICA is the first multicentre study evaluating the BASILICA technique in Europe. The technique appeared feasible and effective in preventing TAVI-induced CAO, and one-year clinical outcomes were favourable. The residual risk for CAO requires further study.

Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR)., Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices., Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification., Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001)., Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

Background: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation., Aims: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices., Methods: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed., Results: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14)., Conclusions: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Background: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. The outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF., Aims: The aim of this study was to evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF., Methods: In total, 81 cases of BVF VIV-TAVI (BVF group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control group)., Results: VARC-2-defined device success was 93% in the BVF group and 68.4% in the control group (p<0.001). The mean transvalvular gradient decreased from 37±13 mmHg to 10.8±5.9 mmHg (p<0.001) in the BVF group and from 35±16 mmHg to 15.8±6.8 mmHg (p<0.001) in the control group with a significantly higher final gradient in the control group (p<0.001). The transvalvular gradients did not change significantly over time. In-hospital major adverse events occurred in 3.7% in the BVF group and 7.6% in the control group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors of lower transvalvular gradients., Conclusions: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors of lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.

Background: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown., Aims: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function., Methods: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality., Results: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57)., Conclusions: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.

Aims: The aim of this study was to determine the feasibility of rotational atherectomy (RA) in chronic total occlusion (CTO) PCI and compare the success and complication rates of RA in CTO lesions versus non-occluded lesions. Data on RA in CTO are rare and it is unknown how procedural success and risk of RA in CTO lesions compare to RA in non-CTO lesions., Methods and Results: RA was performed in 392 out of 17,919 PCI procedures (2.2% of the PCI cohort) and classified as RA CTO (n=75) and RA non-CTO (n=317). Procedural success and MACCE in both groups were assessed by two investigators. All RA procedures were analysed for dissections prior to RA, which were defined according to the NHLBI classification. Baseline characteristics were not significantly different in the two groups but, in RA CTO, lesion type was more complex (p<0.001), stented segments were longer (35.0±22.7 vs. 46.0±24.8 mm, p<0.001) and mean burr size was smaller (1.61±0.17 vs. 1.49±0.18 mm, p<0.001). Procedural success and complications were not different (RA non-CTO 96.2% and RA CTO 94.7%, RA non-CTO 2.5% and RA CTO 4.0%, respectively). RA performed in dissection planes had a 100% procedure success rate in CTO and a 92% success rate in non-CTO., Conclusions: RA in CTO is as safe and as effective as RA in non-CTO. The presence of dissections prior to RA in CTO lesions as well as in non-CTO lesions does not seem to have a negative impact on outcome.

Aims: Although several studies have shown positive outcomes after the use of drug-coated balloons (DCB) for in-stent restenosis (ISR), data on randomised controlled trials versus latest-generation drug-eluting stents (DES) are limited. Therefore, in this randomised trial, we sought to evaluate whether a butyryl-tri-hexyl citrate (BTHC)-based paclitaxel DCB is non-inferior to a biodegradable polymer sirolimus-eluting stent (BP-SES) therapy in patients with ISR in either a bare metal stent (BMS) or DES., Methods and Results: A total of 229 patients with ISR in BMS or DES from 13 German centres and one Latvian centre were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as in-stent late lumen loss (LLL) at six months, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03±0.40 mm compared to 0.20±0.70 mm in the DES arm (p=0.40). DCB proved to be non-inferior to DES (Δ = -0.17±0.52 mm, 97.5% CI -∞; -0.01]; p<0.0001). At 12 months, Kaplan-Meier TLF estimates were 16.7% in the DCB arm and 14.2% in the DES arm (p=0.65) and remained similar at 18 months (DCB versus DES: 17.4% versus 19.5%, p=0.88)., Conclusions: In patients with DES or BMS ISR, treatment with a paclitaxel DCB showed similar LLL at six months and TLF rates up to 18 months compared to a second-generation sirolimus DES.

Aims: Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves., Methods and Results: After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071)., Conclusions: Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.

Moving transcatheter valve intervention towards atrioventricular (AV) valves implies increasing complexity. Some of the knowledge that has been generated during the development of mitral devices can be applied to the tricuspid valve (TV). A deep understanding of the peculiar anatomy of the TV and of the right heart chambers, with differences and similarities between the two AV valves, is fundamental to overcoming the specific challenges related to transcatheter TV therapies. The aim of this report is to explore similarities and differences between the mitral and tricuspid valve apparatus, and their interventional implications.

Aims: The aim of this study was to determine the impact of tricuspid regurgitation (TR) on mortality after edge-to-edge percutaneous mitral valve repair (PMVR), and also to analyse whether there is a difference in outcome between patients with improvement of TR after PMVR compared to patients without., Methods and Results: Out of 197 consecutive patients who underwent PMVR, 139 patients with available follow-up (mean 428±386 days) were included in the study. Concomitant moderate/severe TR was present in 58.3% of patients. Kaplan-Meier analysis showed significantly reduced overall survival for patients with moderate/severe TR, compared to patients with none/mild TR (p=0.003). Cox multivariate regression analysis revealed severe TR at baseline as the strongest independent predictor of mortality (HR 4.367, p=0.003). An improvement of the baseline moderate/severe TR was observed in 45.5% of patients at 30-day follow-up. Patients with no improvement of TR after PMVR had a higher midterm mortality compared to patients in whom TR improved (40.5% versus 11.4%, p=0.005)., Conclusions: More than half of patients undergoing PMVR have concomitant moderate/severe TR, which is associated with a worse outcome. Among predictors of mortality after edge-to-edge PMVR, severe TR at baseline is the most important. Patients with no improvement of TR at 30 days after PMVR have a significantly higher mortality at follow-up.

Aims: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice., Methods and Results: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%)., Conclusions: The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

Aims: Factors predicting outcomes after MitraClip implantation are not well defined. We aimed to report the influence of baseline renal function on short-term outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry., Methods and Results: Twenty participating German centres prospectively included 778 patients (mean age 76.0 years [71-81], 38.8% female gender) at high surgical risk (mean logistic EuroSCORE 20% [12-32%]) undergoing TMVR with the MitraClip for the treatment of symptomatic functional (70%) or degenerative (30%) mitral valve regurgitation (FMR, DMR). The patients were stratified according to renal function before clip implantation. The prevalence of moderate to severe renal impairment (glomerular filtration rate [GFR] <60 ml/min) was 62.7% (37.3%, normal renal function [GFR >60 ml/min]; 49.6%, moderate renal impairment [GFR 30-60 ml/min]; 13.1%, severe renal impairment [GFR <30 ml/min]). TMVR was successfully completed in 98.2% of cases; acute procedural failure, in-hospital and 30-day mortality rates were 1.8%, 2.3% and 4.4%, respectively. Acute procedural failure and mortality rates (in-hospital, 30-day) were significantly higher in patients with severe renal impairment (5.9%, 7.8%, 14.1%), as compared to patients with moderately (1%, 1.3%, 3.0%) or mildly impaired to normal (1.4%, 1.7%, 2.9%) renal function (p<0.0001). Following Cox regression analysis, the prevalence of severe renal impairment at the time of TMVR was the only predictor for increased 30-day mortality rates (hazard ratio 3.42, 95% confidence interval 1.88-6.2; p<0.0001)., Conclusions: Renal function at the time of interventional mitral valve repair with the MitraClip system is a strong predictor for procedural outcomes. Patients with severe renal impairment have a more than threefold increased risk for acute procedural failure, in-hospital death and 30-day mortality.

Aims: Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure., Methods and Results: Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status., Conclusions: For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

Aims: To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension., Methods and Results: In this prospective, multicentre, single-arm study, 146 patients (age 58.6±10.5 years; 61% men) with office systolic blood pressure (BP) ≥160 mmHg despite ≥3 antihypertensive medications at maximally tolerated doses were treated with the Vessix System. Efficacy endpoints were reductions in office and 24-hour ambulatory systolic and diastolic BPs at six months. Acute and long-term safety, with a focus on the renal artery and estimated glomerular filtration rate (eGFR), were assessed. Baseline office and ambulatory BPs were 182.4±18.4/100.2±14.0 mmHg and 153.0±15.1/87.5±13.2 mmHg, respectively. No acute renal artery injury requiring intervention or serious periprocedural cardiovascular events occurred. At six months, office BP was reduced by 24.7±22.1/10.3±12.7 mmHg (p<0.0001) and ambulatory BP was reduced by 8.4±14.4/5.9±9.1 mmHg (N=69; p<0.0001). Twenty-six patients (18%) achieved an office systolic BP <140 mmHg. One patient had renal artery stenosis which required stenting. Mean eGFR remained stable., Conclusions: Renal artery denervation with the Vessix System reduced both office and ambulatory BP at six months in patients with resistant hypertension. Renal artery safety and renal function results are favourable.

Aims: To assess the two-year clinical follow-up of the NEVO RES-1 study, a randomised comparison between the NEVO™ sirolimus-eluting coronary stent system (NEVO SES) and the TAXUS Liberté™ paclitaxel-eluting stent (TAXUS PES)., Methods and Results: NEVO RES-I randomised 394 patients with single de novo lesions with a maximum length of 28 mm and diameter of 2.5-3.5 mm to NEVO SES (n=202) versus TAXUS PES (n=192). Six-month angiographic results demonstrated the superiority of the NEVO SES over the TAXUS PES for the primary endpoint, in-stent late loss. At one year, MACE (death, emergent CABG, TLR, and MI) in the NEVO SES group was 6.1% versus 10.6% in the TAXUS PES group (p=0.139). After two years, MACE was 7.2% in the NEVO SES group versus 13.0% in TAXUS PES group (p=0.086). Corresponding rates of TLR were 3.6% versus 7.6% (p=0.116). No ARC-defined definite or probable stent thromboses (ST) were reported with NEVO SES while two occurred with TAXUS PES., Conclusions: While not designed or powered for clinical endpoints, individual and composite clinical endpoints numerically favoured the NEVO SES over the TAXUS PES, with continued separation over time up to two years. No ARC-defined definite or probable ST was reported in the NEVO SES group at two years. Clinical trial identifier: NCT00606333 http://www.clinicaltrials.gov.

Aims: The influence of age on baseline demographics and outcomes of patients selected for MitraClip has not been previously investigated., Methods and Results: Baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥76 years and 539 patients <76 years). In elderly patients, logistic EuroSCORE was higher (25[15-40]% vs. 18[10-31]%, p<0.0001) and the proportion of women was greater (47.2% vs. 29.3%, p<0.0001). Elderly patients were more likely to have preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%, p<0.0001) and degenerative mitral regurgitation (DMR, 35.3% vs. 25.6%, p<0.01). Age was the most frequent reason for non-surgical treatment in the elderly (69.4% vs. 36.1%, p<0.0001). The intrahospital MACCE (death, myocardial infarction, stroke) was low in both groups (3.5% vs. 3.4%, p=0.93) and the proportion of non-severe mitral regurgitation at discharge was similar (95.8% vs. 96.4%, p=0.73). A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged home (81.8% vs. 86.2%, p=0.06)., Conclusions: Elderly and younger patients have similar benefits from MitraClip therapy. Age was the most frequent cause for denying surgery in elderly patients.

Aims: To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve., Methods and Results: The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days., Conclusions: The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

Aims: The aim of the present study was to evaluate the outcome of carotid artery stenting (CAS) in a single, high-volume centre of a single operator and to analyse the circumstances under which complications occur. Recent trials comparing CAS with carotid endarterectomy demonstrated controversial results. The low experience of interventionists in performing CAS was a major limitation of these studies. The number of procedures needed to achieve optimal skills is unknown., Methods and Results: From May 1997 until April 2010, 1,004 patients with symptomatic or asymptomatic carotid artery stenosis underwent CAS by a single operator. A cerebral protection device was in mandatory use since 2000. In-hospital complication rates were defined as the cumulative rate of death, myocardial infarction or stroke. Procedural success was achieved in 97.77% of patients. The perioperative complication rate was 1.69% including 0.2% deaths, 1.1% patients with minor stroke, 0.4% patients with major stroke. In 88% (15 out of 17) of the patients with complications, unfavourable anatomical or procedural factors could be identified. After the first 100 CAS performed,the complication rate was at 3% and significantly decreased to 1% after more than 500 procedures. Patients ≥80 years had a significantly higher complication rate., Conclusions: In a high-volume experienced centre, the in-hospital complication rate is low. Complications occurred almost exclusively in patients with unfavourable anatomical or procedural characteristics and seem to be avoidable in most patients. A learning curve was observed up to 500 procedures. Elderly patients have a higher complication rate.

Aims: The major challenge for the interventional treatment of chronic total coronary occlusion (CTO) is a low primary success rate. A common problem is the passage of the recanalisation wire into a subintimal position. New devices, which were evaluated in the first multicentre study in CTOs resistant to a conventional wire approach, may help to facilitate a controlled re-entry into the true lumen. The aim of this study was to assess the safety and efficacy of this approach, with successful true lumen distal wire passage as the primary endpoint., Methods and Results: Forty-two patients were enrolled in four centres with high expertise in PCI for CTOs. All CTOs were of at least three months duration, and were initially attempted with dedicated recanalisation wires. After failure to pass or creation of a subintimal dissection, the BridgePoint devices were applied, consisting of a ball-tipped catheter (CrossBoss) to pass the proximal occlusion cap, and a flat-shaped balloon catheter (Stingray catheter) to be inflated within the subintimal space to guide the re-entry into the true vessel lumen with a special wire (Stingray guidewire). The primary endpoint was met in 67% of all patients. A higher success rate seemed to be possible when all devices were used in sequenced beginning with the CrossBoss, and in the case of a subintimal passage, followed by the Stingray. True lumen re-entry failed because of the loss of distally contrast filling and thus loss of a target for re-entry, and by a failure to advance the Stingray balloon far enough distal and parallel to the distal lumen. There were no severe device related complications., Conclusions: In patients with complex CTOs referred to dedicated centres with high experience in CTOs, these results demonstrate the potential of a guided re-entry from a subintimal wire position by use of the BridgePoint devices.

Aims: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter-defibrillators (ICD)., Methods and Results: Patients were randomised 2:1 to autologous skeletal myoblast therapy vs. optimal medical treatment. The primary safety end-point was defined as the incidence of procedural and device related serious adverse events, whereas the efficacy endpoints were defined as the change in global LVEF by MUGA scan, change in NYHA classification of heart failure and in the distance achieved during a six-minute walk test (6MW) at 6-month follow-up. Forty subjects were randomised to the treatment arm (n=26), or to the control arm (n=14). There were 12 sustained arrhythmic events and one death after episodes of ventricular tachycardia (VT) in the treatment group and 14 events in the control group (P=ns). At 6-month follow-up, 6MW distance improved by 60.3±54.1?meters in the treated group as compared to no improvement in the control group (0.4±185.7?meters; P=ns). In the control group, 28.6% experienced worsening of heart failure status (4/14), while 14.3% experienced an improvement in NYHA classification (2/14). In the myoblast-treatment arm, one patient experienced a deterioration in NYHA classification (8.0%), whereas five patients improved one or two classes (20.0%; P=0.06). However, therapy did not improve global LVEF measured by MUGA at 6-month follow-up., Conclusions: These data indicate that implantation of myoblasts in patients with HF is feasible, appears to be safe and may provide symptomatic relief, though no significant effect was detected on global LVEF.

Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer., Methods and Results: The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR., Conclusions: This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development., Methods and Results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation., Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Aims: Recanalisation rates of coronary chronic total occlusions (CTO) remain sub-optimal. The retrograde technique was recently introduced to improve success rates., Methods and Results: From February 2005 until December 2007, 175 patients were treated with this technique in seven European centres by highly experienced operators: in 84 (48%) as primary strategy, in 41 (23.5%) immediately after antegrade failure and in 50 (28.5%) as a repeat procedure after previous antegrade failure. Baseline characteristics revealed a mean age 61.4 +/- 10.8 years with 29.5% and 39% of patients having diabetes and a prior history of MI, respectively. The mean occlusion duration was 50.8 months (determined in 32% of patients). The target vessel was: LAD 21%, LCX 6.3%, RCA 71.4%. Epicardial collaterals were accessed in 20.6% and septal in 79.4% of the patients. Overall success rate was 83.4%. In 80.6% a wire crossed the collaterals and successfully delivered distal to the occlusion; success rate in this group was 91.5%. The technique implemented in the retrograde facilitated successful recanalisation was: retrograde wire/balloon crossing in 28%, CART in 34% and marker wire/"knuckle" technique in 48%. There was a great diversity between centres referring to the retrograde technique used. According to the initial strategy success rates were: primary 89.3%, immediately after antegrade failure 65.9% and repeat procedure after antegrade failure in 88%. In patients with failure to cross the collaterals success rate was 50%. Septal rupture/haematoma occurred in 6.9% of the patients, periprocedural myocardial infarction (CK-MB rise) in 4% and TIA in 0.6% and wire entrapment in 0.6%. Mean fluoroscopy time was 59.3 mn and the mean contrast used was 420.9 ml. Drug eluting stents were implanted in all successfully recanalised vessels., Conclusions: There is great diversity amongst European centres with respect to how the retrograde strategy has been adopted and adapted. The retrograde approach was used with high degree of success and safety and can thus be regarded as a valid contributor to the armamentarium of the modern day interventional cardiologist.