Sensor-guided transcatheter aortic valve replacement.

OBJECTIVES: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population. METHODS: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure. RESULTS: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires. CONCLUSIONS: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.

Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block.

Patients with new-onset left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI) are at risk of developing delayed high-degree atrioventricular block. Management of new-onset LBBB post-TAVI remains controversial. In the Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-Guided Algorithmic Approach in Patients With a New LBBB After TAVI (COME-TAVI) trial, consenting patients with new-onset LBBB that persists on day 2 after TAVI, meeting exclusion/inclusion criteria, are randomized to an electrophysiological study (EPS)-guided approach or 30-day electrocardiographic monitoring. In the EPS-guided approach, patients with a His to ventricle (HV) interval ≥ 65 ms undergo permanent pacemaker implantation. Patients randomized to noninvasive monitoring receive a wearable continuous electrocardiographic recording and transmitting device for 30 days. Follow-up will be performed at 3, 6, and 12 months. The primary endpoint is a composite outcome designed to capture net clinical benefit. The endpoint incorporates major consequences of both strategies in patients with new-onset LBBB after TAVI, as follows: (i) sudden cardiac death; (ii) syncope; (iii) atrioventricular conduction disorder requiring a pacemaker (for a class I or IIa indication); and (iv) complications related to the pacemaker or EPS. The trial incorporates a Bayesian design with a noninformative prior, outcome-adaptive randomization (initially 1:1), and 2 prespecified interim analyses once 25% and 50% of the anticipated number of primary endpoints are reached. The trial is event-driven, with an anticipated upper limit of 452 patients required to reach 77 primary outcome events over 12 months of follow-up. In summary, the aim of this Bayesian multicentre randomized trial is to compare 2 management strategies in patients with new-onset LBBB post-TAVI-an EPS-guided approach vs noninvasive 30-day monitoring. Trial registration number: NCT03303612.

Les patients chez qui un bloc de branche gauche (BBG) est récemment apparu à la suite de l'implantation valvulaire aortique par cathéter (IVAC) présentent un risque de bloc auriculoventriculaire de haut degré tardif. La prise en charge d'un BBG récemment apparu après une IVAC demeure controversée. Dans le cadre de l'essai COME-TAVI (Comparison of a ClinicalMonitoring Strategy VersusElectrophysiology-Guided Algorithmic Approach in Patients With a New LBBB AfterTAVI, ou comparaison d'une stratégie de surveillance clinique, par rapport à une approche guidée par étude électrophysiologique et fondée sur un algorithme, chez des patients présentant un BBG d'apparition récente à la suite d'une IVAC), des patients qui présentent un BBG d'apparition récente persistant le 2e jour après une IVAC, qui répondent aux critères d'admissibilité et qui ont donné leur consentement sont répartis aléatoirement pour être suivis à l'aide d'une approche guidée par une étude électrophysiologique (EEP) ou faire l'objet d'une surveillance électrocardiographique d'une durée de 30 jours. Un stimulateur cardiaque est implanté chez les patients du groupe de l'EEP dont l'intervalle HV (temps de conduction dans le tronc du faisceau de His jusqu'aux ventricules) est ≥ 65 ms. Les patients du groupe de surveillance non invasive reçoivent un dispositif portable d'enregistrement et de transmission continue de données électrocardiographiques pour une période de 30 jours. Le suivi sera réalisé aux 3e, 6e et 12e mois. Le critère d'évaluation principal est un paramètre composite conçu afin de saisir le bienfait clinique net. Il comprend les conséquences majeures des deux stratégies chez les patients présentant un BBG d'apparition récente après une IVAC, comme suit : (i) mort subite d'origine cardiaque; (ii) syncope; (iii) trouble de la conduction auriculoventriculaire nécessitant la pose d'un stimulateur cardiaque (pour une indication de classe I ou IIa); et (iv) complications relatives au stimulateur cardiaque ou à l'EEP. L'essai intègre une conception bayésienne avec une répartition aléatoire (dans un rapport initial de 1:1) antérieure non informative adaptée aux résultats et deux analyses intermédiaires définies au préalable lorsque 25 % et 50 % du nombre anticipé des critères d'évaluation principaux seront atteints. L'essai est axé sur les événements, et la limite supérieure anticipée pour atteindre 77 événements relatifs aux critères d'évaluation principaux sur 12 mois de suivi est de 452 patients. En résumé, l'objectif de cet essai bayésien multicentrique à répartition aléatoire est de comparer deux stratégies de prise en charge de patients présentant un BBG d'apparition récente après une IVAC, soit une approche guidée par une EEP, par rapport à une surveillance non invasive de 30 jours. Trial registration number: NCT03303612.

Transcatheter valvular therapies in patients with left ventricular assist devices.

Aortic, mitral and tricuspid valve regurgitation are commonly encountered in patients with continuous-flow left ventricular assist devices (CF-LVADs). These valvular heart conditions either develop prior to CF-LVAD implantation or are induced by the pump itself. They can all have significant detrimental effects on patients' survival and quality of life. With the improved durability of CF-LVADs and the overall rise in their volume of implants, an increasing number of patients will likely require a valvular heart intervention at some point during CF-LVAD therapy. However, these patients are often considered poor reoperative candidates. In this context, percutaneous approaches have emerged as an attractive "off-label" option for this patient population. Recent data show promising results, with high device success rates and rapid symptomatic improvements. However, the occurrence of distinct complications such as device migration, valve thrombosis or hemolysis remain of concern. In this review, we will present the pathophysiology of valvular heart disease in the setting of CF-LVAD support to help us understand the underlying rationale of these potential complications. We will then outline the current recommendations for the management of valvular heart disease in patients with CF-LVAD and discuss their limitations. Lastly, we will summarize the evidence related to transcatheter heart valve interventions in this patient population.

Growth Differentiation Factor-15 as a Predictor of Functional Capacity, Frailty, and Ventricular Dysfunction in Patients With Aortic Stenosis and Preserved Left Ventricular Ejection Fraction.

In aortic stenosis (AS), left ventricular (LV) remodeling often occurs before symptom onset, and early intervention may be beneficial. Risk stratification remains challenging and identification of biomarkers may be useful. We evaluated the association between growth differentiation factor-15 (GDF-15) and soluble suppression of tumorigenicity 2 (sST2) and known markers of poor prognosis in AS. Baseline plasma GDF-15 and sST2 levels were measured in 70 patients with moderate-severe AS (aortic valve area <1.5 cm2) and preserved LV ejection fraction (>45%). Patients were categorized into "low GDF-15" versus "high GDF-15" and "low sST2" versus "high sST2" groups. Groups were compared for differences in cardiovascular risk factors, 6-minute walk test, 5 m gait speed, cognitive function (Montreal Cognitive Assessment), and echocardiographic parameters. Overall, 44% of patients were deemed asymptomatic by New York Heart Association class, 61% had severe AS (aortic valve area <1 cm2) and all patients had preserved LV ejection fraction. GDF-15 levels were not predictive of AS severity. However, high GDF-15 (>1,050 pg/ml) was associated with LV dysfunction as shown by lower indexed stroke volume (p <0.01), worse LV global longitudinal strain (p = 0.04), greater mean E/e' (p = 0.02) and indexed left atrial volume (p <0.01). It was also associated with decreased functional capacity with shorter 6-minute walk test (p = 0.01) and slower 5 m gait speed (p = 0.02). Associations between sST2 levels and markers of poor prognosis were less compelling. In this study of patients with moderate to severe AS, elevated GDF-15 levels are associated with impaired functional capacity, poorer performance on fragility testing, and LV dysfunction. In conclusion, GDF-15 may integrate these markers of adverse outcomes into a single biomarker of poor prognosis.

Hybrid off-pump debranching and thoracic endovascular arch repair in a high-risk surgical patient.

Management of aortic arch pathologies remains challenging. Open total arch replacements have been associated with significant morbidity and mortality owing to the need for cardiopulmonary bypass and circulatory arrest. On the other hand, aortic arch-branched stent grafts are not widely available. In this context, hybrid techniques combining open arch debranching with endovascular graft placement have been identified as an attractive option in select patients. However, there still is a paucity of literature on their application and outcomes. A case is presented of an elderly frail patient diagnosed with a pseudoaneurysm of the aortic arch and who was successfully treated by an off-pump arch debranching followed by endovascular arch repair. This case highlights (i) the feasibility of hybrid debranching techniques, (ii) their technical challenges, and (iii) the need for long-term follow-up data.

Electroanatomical Navigation to Minimize Contrast Medium or X-Rays During Stenting: Insights From an Experimental Model.

Stents can be effectively implemented with no x-rays or contrast medium. Modified stents were successfully implanted in 9 of 11 attempted targets (82%) (7 carotid and 4 coronary arteries) using an impedance-sensitive navigation system and optical coherence tomography. Electroanatomical navigation systems can be used to assist interventionalists in performing arterial stenting while minimizing x-ray and contrast use, thereby potentially enhancing safety for both patients and catheterization laboratory staff members.

Peripheral Interventions Radiation Exposure Reduction Using a Sensor-Based Navigation System: A Proof-of-Concept Study.

BACKGROUND: Intravascular catheter positioning is done with radiography imaging. Increasing evidence indicates excessive ionizing radiation exposure for patients and physicians during catheterization procedures, making solutions to reduce radiation exposure a priority. This study evaluated the feasibility and impact of using sensor-based magnetic navigation on (i) fluoroscopy time and (ii) positioning accuracy and safety of a peripheral angioplasty balloon catheter. METHODS: All patients (n = 10) underwent a balloon-positioning protocol using 2 navigation methods sequentially: (i) magnetic navigation with minimal fluoroscopy; (ii) fluoroscopic navigation. The navigation method order was randomized, and 4 consecutive placements per method were performed. A target vascular bifurcation was used as a fiduciary landmark for both methods to determine accuracy. RESULTS: Balloon placements were successful with both navigation methods in all subjects, and no adverse events occurred. Magnetic guidance led to significant reductions in fluoroscopy time (0.37 ± 1.5 vs 15.0 ± 8.1 seconds, P < 0.001) and dose (0.3 ± 1.2 vs 24.1 ± 23.8 µGy.m2, P < 0.01). The time duration for balloon alignment was similar for the 2 navigation methods (4.8 ± 1.4 vs 4.8 ± 2.3 seconds, P = 0.89), and the accuracy was almost identical (0.51 ± 0.41 vs 0.51 ± 0.32 mm, P = 0.97). CONCLUSIONS: These results demonstrate the feasibility of using sensor-based magnetic guidance during simple peripheral interventional procedures; a significant reduction in ionizing radiation was achieved, with excellent positioning accuracy and safety. The clinical applications of magnetic guidance for device navigation during more complex percutaneous procedures should be evaluated.

CONTEXTE: Le positionnement d'un cathéter intravasculaire fait appel à l'imagerie radiographique. De plus en plus de données probantes indiquent que les patients et les médecins subissent une surexposition aux rayonnements ionisants pendant le cathétérisme, ce qui fait des solutions de réduction de l'irradiation une priorité. Cette étude a permis d'évaluer la faisabilité du guidage magnétique par capteur et son effet sur (i) la durée de la fluoroscopie et (ii) la précision et la sécurité du positionnement d'un cathéter d'angioplastie périphérique à ballonnet. MÉTHODOLOGIE: Chez tous les patients (n = 10), le positionnement du ballonnet a été effectué en fonction d'un protocole fondé sur deux méthodes de guidage mises en œuvre séquentiellement : (i) guidage magnétique avec fluoroscopie minimale; (ii) guidage fluoroscopique. L'ordre dans lequel les méthodes de guidage ont été mises en œuvre a été randomisé, et quatre positionnements consécutifs par méthode ont été effectués. Une bifurcation vasculaire cible a servi de repère de fond de chambre afin de déterminer la précision des deux méthodes. RÉSULTATS: Les deux méthodes de guidage ont permis un positionnement adéquat du ballonnet chez tous les patients, et aucun événement indésirable n'est survenu. Le guidage magnétique a entraîné des réductions significatives de la durée de la fluoroscopie (0,37 ± 1,5 vs 15,0 ± 8,1 secondes, p < 0,001) et de la dose de rayonnement (0,3 ± 1,2 vs 24,1 ± 23,8 µGy.m2, p < 0,01). La durée de l'alignement du ballonnet était similaire lors de la mise en œuvre des deux méthodes de guidage (4,8 ± 1,4 vs 4,8 ± 2,3 secondes, p = 0,89), et la précision était presque identique (0,51 ± 0,41 vs 0,51 ± 0,32 mm, p = 0,97). CONCLUSIONS: Ces résultats démontrent la faisabilité du guidage magnétique par capteur dans le cadre d'angioplasties périphériques simples. L'exposition aux rayonnements ionisants a été réduite de façon significative, et la précision ainsi que la sécurité du positionnement se sont avérées excellentes. Les applications cliniques du guidage magnétique dans le contexte d'interventions percutanées plus complexes représentent une avenue de recherche à explorer.

Right Ventricular Outflow Tract Obstruction in Adults: A Systematic Review and Meta-analysis.

BACKGROUND: Right ventricular outflow tract obstruction (RVOTO) is a cause of hemodynamic instability that can occur in several situations, including cardiac surgery, lung transplantation, and thoracic surgery, and in critically ill patients. The timely diagnosis of RVOTO is important because it requires specific considerations, including the adverse effects of positive inotropes, and depending on the etiology, the requirement for urgent surgical intervention. METHODS: The objective of this systematic review and meta-analysis was to determine the prevalence of RVOTO in adult patients, and the distribution of all reported cases by etiology. RESULTS: Of 233 available reports, there were 229 case reports or series, and 4 retrospective cohort studies, with one study also reporting a prospective cohort. Of 291 reported cases of RVOTO, 61 (21%) were congenital, 56 (19%) were iatrogenic, and 174 (60%) were neither congenital nor iatrogenic (including intracardiac tumour). The mechanism of RVOTO was an intrinsic obstruction in 169 cases (58%), and an extrinsic obstruction in 122 cases (42%). A mechanical obstruction causing RVOTO was present in 262 cases (90%), and 29 cases of dynamic RVOTO (10%) were reported. In the 5 included cohorts, with a total of 1122 patients, the overall prevalence was estimated to be 4.0% (1%-9%). CONCLUSIONS: RVOTO, though rare, remains clinically important, and therefore, multicentre studies are warranted to better understand the prevalence, causes, and consequences of RVOTO.

CONTEXTE: L'obstruction de la chambre de chasse du ventricule droit (OCCVD) est une cause d'instabilité hémodynamique qui peut survenir dans plusieurs situations, y compris une chirurgie cardiaque, une transplantation pulmonaire ou une chirurgie thoracique, ou encore chez des patients en phase critique. Il est important que le diagnostic d'OCCVD soit posé rapidement, car d'une part cette affection exige la prise en compte d'éléments particuliers, y compris les effets indésirables des agents inotropes positifs et, d'autre part, en fonction de l'étiologie, une intervention chirurgicale d'urgence pourrait être nécessaire. MÉTHODOLOGIE: L'objectif de cette revue systématique associée à une méta-analyse était de déterminer la prévalence de l'OCCVD chez les patients adultes ainsi que la distribution de tous les cas rapportés en fonction de leur étiologie. RÉSULTATS: Sur les 233 rapports disponibles, on comptait 229 études ou séries de cas, et quatre études de cohortes rétrospectives, dont une qui présentait également les résultats d'une cohorte prospective. Sur 291 cas d'OCCVD rapportés, 61 (21 %) étaient d'origine congénitale, 56 (19 %) étaient d'origine iatrogène et 174 (60 %) avaient une origine qui n'était ni congénitale ni iatrogène (dont une tumeur intracardiaque). Le mécanisme de l'OCCVD était une obstruction intrinsèque dans 169 cas (58 %), et une obstruction extrinsèque dans 122 cas (42 %). Une obstruction mécanique causant l'OCCVD était présente dans 262 cas (90 %), et 29 cas d'OCCVD dynamique (10 %) ont été rapportés. Dans les 5 cohortes incluses, comptant au total 1 122 patients, la prévalence globale était estimée à 4,0 % (de 1 % à 9 %). CONCLUSIONS: L'OCCVD, malgré sa rareté, n'en est pas moins importante sur le plan clinique; la réalisation d'études multicentriques serait donc justifiée pour permettre de mieux comprendre la prévalence, les causes et les conséquences de cette affection.

Optimizing Timing of Valve Intervention in Patients With Asymptomatic Severe Valvular Heart Disease.

The management of valvular heart disease has changed dramatically over the past decade with advances in cardiac imaging, the use of novel biomarkers, and the development of transcatheter valve repair and replacement technology. International society guidelines have kept pace to provide recommendations for diagnosis, follow-up, and timing of intervention. The most challenging patient cohort for clinicians are patients with asymptomatic severe disease in whom the optimal timing of intervention can be ill-defined. It is a fine balance between the risks of early intervention on asymptomatic patients and improving patient outcomes by preventing long-term cardiac complications. The key in optimal patient management is gathering the necessary information on patient risk and combining that with the risk, efficacy, and durability of valve interventions to arrive at the appropriate timing for intervention. This group of patients will be the focus of this review as we delve into the natural history, recommended follow-up, and indications for intervention in patients with degenerative aortic and mitral valve disease.

Clinical outcomes of bioresorbable vascular scaffold to treat all-comer patients. Are patients with acute coronary syndrome better candidates for bioresorbable vascular scaffold?

BACKGROUND: Scaffold thromboses (ST) and adverse events and have been associated with bioresorbable vascular scaffolds (BVS) at long-term, but their mechanism remains unclear. We sought to evaluate patient and lesion characteristics associated with mid- to long-term outcomes in patients treated with BVS. METHODS: This is an observational single-center, single-arm, retrospective study evaluating the performance of BVS in an all-comer population, including complex lesions (chronic total occlusions, long lesions), small vessels, and acute coronary syndromes (ACS). RESULTS: From May 2013 to June 2015, we included 482 patients (580 lesions) that were treated with BVS implantation including 71.2% treated for ACS in the present analysis. Mean follow-up period was 816.2 ±â€¯242.6 days. The primary endpoint was device oriented cardiac events (DOCE), defined as a composite of target-lesion revascularization (TLR), ST, target vessel myocardial infarction (TVMI) and cardiac death. Using Kaplan-Meier methods, the DOCE and ST rates at 36 months were 9.4% and 2.3%, respectively. No ST occurred between 2 and 3 years and ST occurred after 3 years, in one patient. Using multivariate analysis, ACS was the only significant predictor of lower rates of DOCE (p = 0.04, HR: 0.47, 95% CI: 0.23-0.96). CONCLUSIONS: In this large all-comers real-world cohort, lesions treated with BVS had non-negligible rates of DOCE and ST, in line with previous published randomized trials. The occurrence of very late event was very low after 24 months. ACS patients had lower rates of DOCE.

Cost consequence analysis of use of a balloon expandable vascular access system and standard vascular sheath for transcatheter aortic valve implantation.

BACKGROUND: Vascular complications are an important complication of transcatheter aortic valve implantation and are associated with increased morbidity and mortality as well as cost. The Solopath device is an expandable vascular access system that has previously been shown to be associated with lower rates of vascular complications. This study sought to evaluate the impact of the use of this system on vascular complications and costs in a decision model analysis. METHODS: A cost-consequence analysis was undertaken utilizing event rate data from the PARTNER trials and a published retrospective analysis of the Solopath device. The decision model estimated costs and benefits in a hypothetical cohort of patients with aortic stenosis undergoing TAVI using either a standard sheath or Solopath. The modeled analysis compared the occurrence of vascular complications and mortality at 30 days and 1 year using TreeAge Pro. RESULTS: The decision model demonstrated that use of the Solopath sheath resulted in 36 fewer major vascular complications, three fewer deaths at 30 days, and five fewer deaths at 1 year, resulting in a discounted cost savings of $846 CDN. Results were sensitive to decreasing rates of vascular complications with newer generation devices, however maintained modest cost-savings. CONCLUSIONS: Reduction in vascular complications is an important part of improving care for TAVI patients. The Solopath vascular access device offers an alternative to standard sheaths with a potential reduction in complications and cost-savings.

Long-term outcomes of bioresorbable vascular scaffold in ST-elevation myocardial infarction.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients. METHODS: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients. RESULTS: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26-2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS). CONCLUSIONS: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.

Everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease, single-center initial experience.

AIMS: Recent studies have shown favorable outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking. METHODS AND RESULTS: A total of 10 consecutive patients (13 lesions, including 6 in-stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow-up period was 874 (720-926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in-stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients CONCLUSIONS: This first real-world data on the use of the ABSORB™ BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug-eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.

Bioresorbable vascular scaffold to treat in-stent restenosis: Single-center experience.

AIMS: The management of patients with in-stent restenosis (ISR) is still a major clinical challenge even in the era of drug-eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long-term results of our preliminary experience with this novel approach at our institution. METHODS AND RESULTS: We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow-up was available in 91.9% of the patients. Mean follow-up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow-up (16.2%). CONCLUSIONS: These real-world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB™ BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis-generating for larger randomized controlled studies.

Results of a multimodal approach for the management of aortic coarctation and its complications in adults.

OBJECTIVES: We aimed to assess the results of various tailored management strategies for adults with coarctation in our centre. METHODS: We reviewed all adults patients treated for aortic caorctation between January 2000 and December 2015 in our institution. The primary end point was a composite of death, perioperative stroke, paraplegia, need for unplanned reoperation or occurrence of pseudoaneurysm during the follow-up. The mean follow-up was 82 ± 5 months. RESULTS: Sixty-three adults were treated for a native coarctation (n = 34), a recurrent coarctation (n = 14) or aneurysmal complication (n = 15). Mean age of the patients was 42 ± 1.7 years. All but 1 patient with native coarctation (33/34, 97%) and recurrent coarctation (13/14, 93%) underwent endovascular repair and 10 (67%) patients with aneurysmal complications were treated surgically. Freedom from the primary composite end point was 94, 84 and 81% at 1, 5 and 10 years, respectively, without difference between the 3 indication groups (P = 0.96). CONCLUSIONS: A tailored management strategy is necessary to provide good results for the treatment of adults with aortic coarctation. Thus, centres that are involved in the care of this complex pathology should be able to propose a multimodal approach, either endovascular or surgical depending on patient's characteristics and anatomic features.