Highlights from the Innovations in Cardiovascular Interventions Meeting: in favor of creativity and ingenuity

Abstract

The annual Innovations in Cardiovascular Interventions Meeting was organized in close collaboration with the Cardiovascular Research Foundation and was co-sponsored by the Society for Coronary Angiography and Interventions. The meeting was co-chaired by Rafael Beyar and Chaim Lotan, and took place in Tel Aviv, Israel, on 6–8 December 2009. It was a continuation of the series of international conferences in interventional cardiology held in Israel since 1995. The meeting is distinctive in that it provides a wide perspective on the innovative technologies and therapies for cardiovascular applications. Unique sessions covering emerging technologies, relationships between academia and industry, as well as regulatory aspects of medical devices provided participants with a wide perspective on current and future technologies. The Innovations in Cardiovascular Interventions Meeting was attended by over 700 participants from over 40 countries, including cardiologists, surgeons, nurses, pharmacists and allied health professionals. The world’s leading experts in the field of interventional cardiology, cardiac surgery and radiology presented the latest information on innovative diagnostic and treatment modalities for cardiovascular pathology, and delivered expert lectures and clinical overviews, as well as presentations on the advances and controversies in basic, translational and clinical research. The meeting was accompanied by thematic live cases and a parade of new technology companies. Innovations in Cardiovascular Interventions Meeting 2009 presentations are available to watch and download at www.congress.co.il/ici2009.

The opening plenary session focused on the challenges facing progress in research, innovative technology and therapies in cardiovascular interventions. In recognition of his tremendous contribution to the development and advancement of the transcatheter aortic valve implantation (TAVI) device, Alain Cribier (University Hospital Charles Nicolle, Rouen, France) was presented with the annual Innovations in Cardiovascular Interventions (ICI) Achievement Award.

Technology parade

The hallmark of the ICI 2009 meeting was the technology parade. This ongoing core session was dedicated to new innovative and emerging technologies. The parade provided a stage for start-up companies and scientists to present new concepts and initial data. The exciting sessions included short, structured presentations that exposed the audience to the future of interventional cardiology. Questions addressed were: how would our catheterization laboratory team perform in the next decade? What new imaging and navigation modalities, as well as therapeutic devices and technologies, may change the interventional practice? The multitude of new ideas and technologies convinced the organizers to divide the parade into three distinct sessions, each dedicated to a different theme.

Heart failure, refractory angina & beyond

This session gave a glimpse to the future of monitoring and treatment of heart failure patients. Daniel Burkhoff (Columbia University, NY, USA) presented a novel noninvasive technique for cardiac output monitoring. The bioreactance technique is based on the analysis of flow-dependent phase shifts of electric currents that are injected across the thorax [1]. This novel technique was recently clinically applied for cardiac resynchronization therapy optimization and for the monitoring of fluid balance in a patient with coronary heart failure. Another noninvasive diagnostic tool for systolic failure is the noninvasive cardiac system – cardiac surveyor, an impedance cardiographic cardiac surveyor that utilizes a rapid algorithm for the assessment of left ventricular (LV) dysfunction [2]. Yaron Moshkovitz (Sheba Medical Center, Israel) presented a comparison between the noninvasive cardiac system and echo, showing a 90% positive-predictive value and 97% negative-predictive value for this novel laptop-based impedance system. David Rigler (BioControl Medical, Israel) described the CardioFit™ system (BioControl Medical), which administers rate-synchronized electrical pulses that are transmitted from an implantable neurostimulator via an electrode, which selectively stimulates efferent right vagal cervical fibers involved in parasympathetic heart control [3]. In a 6-month open-label pilot study of this system in patients with advanced heart failure, the CardioFit system appeared safe, and improved exercise performance, LV function and quality of life. Current medical therapy for diastolic dysfunction is quite disappointing. Amir Elami (Hadassah Medical Center, Israel) presented novel devices developed by CorAssist Cardiovascular (Israel) that enhance LV filling by the transmission of energy from systole to diastole. Animal studies with intraventricular devices and preliminary clinical studies with extraventricular devices demonstrate both safety and efficacy, and call for further studies of this innovative device-based strategy.

Chronic refractory angina therapy with extracorporeal shockwaves that target the ischemic region was discussed by Gil Hakim (Medispec Ltd, MD, USA). A study of 178 patients showed that such therapy significantly improves clinical status as measured by Canadian Cardiovascular Society class and nitrate intake, as well as myocardial perfusion as measured by single photon-emission computed tomography (CT).

Imaging & beyond

For start-up companies that are based on novel ideas, funding is essential. This session was opened with an intriguing lecture on the decreasing funding opportunities for medical device start-ups. Eitan Konstantino (Trireme Medical Inc, CA, USA) discussed new solutions and creative pathways to overcome funding obstacles.

Precise positioning in percutaneous aortic valve implantation presents a new imaging challenge. Amir Blumenfeld (Paieon Medical Ltd., New York, NY, USA) presented the new Paieon system for optimal delivery of the transcatheter valve [4]. The system uses standard fluoroscopy images and does not breach the normal cathlab workflow; it is helpful in planning and positioning of the valve as well as post-deployment evaluation of the implanted valve size.

The ‘COR Analyzer’ of Rcadia Medical Imaging (Israel) is a fully automatic analyzer of coronary CT angiography (CCTA). Roman Goldberg (Rcadia Medical Imaging) presented studies that compared automatic analysis with expert CT readers and quantitative coronary angiography, showing a very high (>95%) negative-predictive value. Thus, such a system may offer a solution in places where experienced CCTA readers are unavailable.

The LightWire™ (Bioscan Technologies Ltd., Israel) is a tiny intravascular ultrasound (IVUS) that is implemented in a 0.014” wire [5]. Stephen Fry (Bioscan Technologies, Ltd.) presented the possible advantages of an IVUS-on-wire, which could make accurate stent deployment and sizing much simpler and less expensive. Future applications of this miniaturizing innovation were discussed, including novel forward-looking tiny probes and multiple sensor probes that allow the real-time imaging of long segments without pullback.

The application of robotics to interventional cardiology was introduced by the CorPath™ system (Corindus Vascular Robotics, MA, USA). This vascular robotic technology aims at improving and standardizing the current performance of percutaneous coronary intervention (PCI) procedures, while reducing radiation exposure and orthopedic injuries to health personnel. Juan Granada (Columbia University Medical Center, NY, USA) presented preliminary animal PCI studies showing the feasibility and safety of this promising robotic system.

New devices for interventional cardiology

This session introduced devices for standard and complex PCI, as well as peripheral procedures and closure devices. Bradley Strauss (University of Toronto, ON, Canada) presented exciting data on the first-in-man (FIM) experience with collagenase for chronic total occlusion revascularization [6]. Strauss’s extensive preclinical work with this fascinating biological strategy reached fruition with encouraging clinical data from the first cases in which previously failed chronic total occlusion cases were successfully reopened. A novel concept for plaque modification and plaque stabilization was presented by Ronda Schreiber (Minnow Medical, CA, USA). The balloon catheter delivers low-radiofrequency energy to the vessel wall, causing controlled heating of the target lesion. Studies in hypercholesterolemic rabbits show luminal gain and reduction of inflammatory content after the treatment of iliac artery lesions. Initial clinical data following the treatment of human superficial femoral artery and popliteal lesions demonstrate safety, and suggest an increased patency and a low restenosis rate.

Embolic stroke is a serious complication of large-bore catheter-based therapies for valvular and aortic pathologies. Yuval Shezifi (SMT Research and Development Ltd, Israel) presented a novel concept developed by SMT Research and Development Ltd to prevent this complication. An embolic diverter is percutaneously deployed in the aortic arc during the high-risk procedure and taken out thereafter. Meticulous flow-dynamic studies and animal experiments have led the way for FIM studies that were carried out immediately after the ICI meeting was held.

Reducing vascular complications following diagnostic and interventional procedures and improving ambulation is the goal of two new devices that were presented at the ICI technology parade. Victor Guetta (Sheba Medical Center, Israel) discussed a novel approach that utilizes heat energy for vascular closure. The device by CardioDex (Israel) causes a thermal response that stimulates arteriotomy shrinkage and vascular closure. Initial clinical data are encouraging and further larger studies are underway. Russ Houser (Vascular Closures System Inc., CA, USA) presented the new FastSteal™ bioabsorbable closure device – a polymer plug element that can be introduced through any commercially available introducer sheath.

A multitude of additional aspects for the improvement of PCI outcome were presented at the technology parade, including new stents, balloons and devices for bifurcation lesions, and the PCI simulator – the Simbionix PROcedure Rehearsal Studio™ (Israel) that enables the import of computed tomography data.

The future of stents

Bioactive & drug-eluting stents

Several sessions were dedicated to coronary/peripheral stents at different stages of development, research and clinical implementation. Alexandre Abizaid (Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil) provided a comprehensive overview on the various generations of stents addressing the future perspectives in stent development. The efficacy of first-generation drug-eluting stents (DESs) with durable polymers was achieved at a cost of delayed arterial healing, mainly due to impaired re-endothelialization, resulting in an increased incidence of late and very late stent thrombosis (ST), thus raising safety concerns with regards to DES technology. Therefore, first-generation stents with durable polymers and thick polymer loading are gradually being replaced by more advanced technology.

Last-generation polymer DESs

The everolimus-eluting XIENCE V^® stent (Abbott Vascular, CA, USA) and the zotarolimus-eluting stent Endeavor^® Resolute (Medtronic CardioVascular, CA, USA) are the latest generation polymer stents demonstrating evidence of improved vascular healing. Gregg W Stone (Columbia University, NY, USA) presented data on a 3-year follow-up from the SPIRIT III and SPIRIT IV randomized trials, providing evidence that lower late loss achived with XIENCE V stent compared with the TAXUS EXPRESS stent does not translate into lower long-term safety [7–9]. Namely, treatment with the XIENCE V stent was associated with significantly lower rates of composite end point of death or myocardial infarction (MI; 5.8 vs 10.0%, respectively; p = 0.02), target lesion revascularization (TLR; 5.4 vs 8.9%; p = 0.05), major adverse cardiac events (MACEs; 9.7 vs 16.4%; p = 0.004) and target vessel failure (TVF; 14.3 vs 20.0%; p = 0.03). ST occurred with a similar incidence (1.3 vs 1.7%; p = 0.77).

An update on the Endeavor Resolute zotarolimus-eluting stent was presented by Stephanie Schultz (Deutsches Herzzentrum, Munich, Germany). In the FIM feasibility single-arm multicenter Randomized, Two-Arm, Non-Inferiority Study Comparing Endeavor-Resolute Stent With Abbot XIENCE V Stent (RESOLUTE) study on 130 patients, the Endeavor Resolute stent had a mean late loss of 0.22 ± 0.27 mm on 8-month angiographic follow-up and very low rates of clinical events at 3 years, including no cases of ST, a 1.5% TLR rate and a 11.5% MACE rate [10]. In the Munich series on 171 consecutive patients with high-risk features for coronary restenosis, the Endeavor Resolute stent showed an excellent safety profile at 9 months, with only one case of ST (0.6%) and low rates of death (2.9%), MI (5.3%; all non-q-wave MIs), TLR (4.1%) and MACE (11%). Results of several ongoing randomized clinical trials (RESOLUTE-All Comers, Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis [ISAR-TEST 5] and Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT MAIN 2]) and registries (RESOLUTE Japan, RESOLUTE Asia–Pacific) are expected to provide further data on the safety and efficacy of the Endeavor Resolute stent.

Biodegradable polymer DES

Philip M Urban (Hopital de la Tour, Switzerland) presented latest results on the BioMatrix™ biolimus-eluting stent (Biosensors International Group, Ltd., Biosensors Europe SA, Morges, Switzerland) from the Limus Eluted from a Durable Versus Erodable Stent Coating (LEADERS) trial [11] and the E-BioMatrix registry. In the multicentre randomized LEADERS trial, the BioMatrix stent was found to be noninferior to the sirolimus-eluting stent (SES) for the primary 9-month composite end point of cardiac death, MI or clinically driven TVR (9 vs 11%; p for noninferiority = 0.003) without significant differences in individual clinical outcomes, as well as rates of binary restenosis and in-stent percentage diameter stenosis [11]. Noninferiority of BioMatrix versus SES in an all-comers population was sustained at 2-year follow-up with close rates of death/MI (8.3 vs 9.1%), TVR (7.7 vs 8.8%), MACE (13.0 vs 15.4%) and ST (2.2 vs 2.5%). Remarkably, however, among patients with ST-segment elevation MI (STEMI), the BioMatrix stent showed superior outcomes compared with SES in terms of 1-year cardiac mortality (1.5 vs 6.4%; p = 0.04) and MACE (6.7 vs 15.7%; p = 0.02), as well as 2-year MACE (8.1 vs 19.3%; p < 0.01). Very late ST events were rare with both stents (0.2% with BioMatrix vs 0.5% with SES; p = 0.73).

Alexandre Abizaid commented on other bioabsorbable polymer DESs. The NEVO™ Sirolimus-Eluting Coronary Stent (Cordis Corporation, NJ, USA) is the DES applying RES Technology™, which incorporates small reservoirs acting as a depot into which drug–polymer compositions are loaded. In vivo, polymer resorption occurs within 3 months. In the prospective, randomized NEVO RES I trial, the use of the NEVO sirolimus-eluting coronary stent compared with the Taxus Liberte stent was associated with significantly lower 6-month in-stent late lumen loss (0.13 vs 0.36 mm; p < 0.001) and binary angiographic restenosis (1.1 vs 8.0%; p < 0.002). There were no cases of ST in the NEVO group versus two cases of ST in the Taxus Liberte group. The JACTAX stent uses the Liberté^® Pre-mounted stent (Boston Scientific Central, MA, USA) and JA^® Coating. When compared with case-matched controls (Taxus Liberte stent arm from the TAXUS ATLAS trial [12]), the JACTAX stent was associated with a trend toward lower rates of 9-month in-stent and in-segment restenosis (5.2 vs 10.2%; p = 0.14 and 6.4 vs 12.0%; p = 0.12, respectively). The promising results have been shown with the use of supralimus-eluting stents (Sahajanand Medical Technologies Pvt. Ltd, Surat, India) in a series of 100 patients with mean late loss of only 0.02 mm within the lesion and 0.09 mm within the stent and no cases of acute, subacute or late thrombosis at 9 months follow-up. The ongoing Randomized Evaluation of an Abluminal Sirolimus Coated Bio-Engineered Stent (REMEDEE) trial will compare safety and efficacy of the OrbusNeich Pro-Healing sirolimus-eluting stent [13] versus Taxus-Liberte with a primary end point of late loss at 9 months. The OrbusNeich Pro-Healing SES consists of a stainless steel alloy coated with a biocompatible, biodegradable polymer containing rapamycin. Covalently attached to this matrix is a layer of murine, monoclonal, antihuman CD34 antibodies to capture endothelial progenitor cells and to promote rapid re-endothelialization.

Ran Kornowski (Rabin Medical Center, Israel) analyzed outcomes from the Nobori 2 prospective multicenter single-arm observational study. This study is a part of the Nobori Clinical Program on the Nobori™ Drug-Eluting Stent System that utilizes Biolimus A9™, an analogue of sirolimus to reduce tissue proliferation that is eluted from a bioresorbable polymer, poly-lactic acid [14]. The study enrolled 1000 consecutive patients in a real-life setting. At 6 months, regardless of indication (on- vs off-label), there were very low 6-month rates of cardiac death (1.0 vs 0.6%), MI (1.6 vs 2.3%), TLR (0.3 vs 1.6%) and MACE (2.6 vs 3.6%). The incidence of TVF at 12 months was also very low (2.8 vs 4.4%).

Non-polymer DES

The BioMatrix Freedom Stent is a new drug-coated stent technology with a polymer-free release of a limus drug from a porous metal stent abluminal surface. At 4 months, there was significant reduction in late loss in both BioFreedom standard-dose (0.08 mm) and low-dose (0.12 mm) groups compared with the Taxus Liberte stent (0.37 mm; p < 0.0001 and p = 0.002, respectively). There were no cases of ST at 4 months.

Amazonia Pax^® DES (Minvasys, France) is an ultra-thin chromium cobalt Amazonia Croco^® stent with a polymer-free abluminal paclitaxel coating achieved by a nonpolymeric microdropped spray process that releases the total loaded drug within 45 days. Mean late loss at 9 months in 15 patients in the PAX A study was 0.36 mm, with a mean volume of neointimal hyperplasia by IVUS of only 6.1 mm³. The PAX B multicenter registry on 100 patients is designed to further evaluate the Amazonia Pax safety profile and strut re-endothelialization 4 months after stent implantation.

The efficacy of another polymer-free stent, the VESTAsync™ (MIV Therapeutics, Inc., Frankfurt, Germany) sirolimus-eluting stent, is being tested in the randomized VESTAsync II trial, with a primary end point of late lumen loss at 6 months [15]. Secondary analyses will be performed that aim to assess volumetric obstruction by IVUS, stent struts coverage by optical coherent tomography (OCT) and endothelial function.

Ron Waksman (Washington Hospital Center, Washington, DC, USA) reported an update on the third generation of Absorbable Magnesium Stents (BIOTRONIK, UK) [16]. Magnesium alloys are believed to provide an excellent balance between biocompatibility, mechanical properties and absorption characteristics for coronary stents. Stent implements the elution of an antiproliferative drug and has shown safety and efficacy in animal studies. A clinical program starts in 2010 with the FIM study.

Bioabsorbable DESs

Patrick W Serruys (Thorax Center, Rotterdam, The Netherlands) analyzed data on 101 patients treated with the Bioabsorbable Everolimus-Eluting Coronary Stent System (BVS EECSS; Abbott Vascular, CA, USA) enrolled in Cohort B of the ABSORB trial [17]. For up to 3 years, no possible, probable or definite ST has been observed. Based on the data of multiple-imaging modalities with data available up to 4 years, Serruys concluded that absorption and vessel wall integration are real phenomena. The data also showed the importance of proper stent and vessel sizing to avoid vessel recoil.

In vivo and in vitro data on the Arterial Remodeling Technologies (ART; France) bioresorbable stent were presented by Antoine LaFont (Hopital Europeen Georges Pompidou, France). The ART proprietary technology platform provides an ultimate balance between stent, mechanics, resorption and biocompatibility. Latest in vivo data confirm ART’s natural healing through a pure resorption strategy.

New-generation bare-metal stents & more

Several presentations focused on the novel bare-metal stents that, according to preliminary results, may compete with DESs with regard to performance, safety and efficacy. Stefan Verheye (Middelheim Hospital, Antwerp, Belgium) focused on the re-emergence of the nitinol self-expanding vProtect™ Luminal Shield (Prescient Medical, PA, USA) coronary stent with Ultra-thin 0.00225” struts that minimize damage to the vessel wall and encourage laminar flow for rapid endothelialization and healing. In the FIM study, procedural success was 96.6% and only 10.3% of the patients had angiographic restenosis at 9 months. In the Shield Evaluated at Cardiac Hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT) trial I, neointimal thickness 9 months postimplantation of the vProtect Luminal Shield was similar to that seen with DESs [18]. The STEMI High-Resolution Imaging Evaluation of Luminal Shields Versus DES (SHIELD) study has been designed to evaluate the clinical benefit of the vProtect design in STEMI patients, testing the hypothesis that self-expanding stents will have a much lower malapposition rate and possibly a lower risk of ST [19].

Nick Kipshidze (Central University Hospital, Georgia), presented results of the Human Prospective Anti-Restenosis Trial (HARTS I), a FIM single-center clinical investigation to evaluate the safety and performance of the Accelerate™-AT coated stent (Biomer Technology Ltd, UK) using a novel, antithrombogenic, biodurable, polymeric coating designed to modulate the adhesion and proliferation response of vascular cells in patients undergoing PCI. The results are promising, with a low magnitude of late loss at 6-month quantitative coronary angiography coupled with minimal neointimal hyperplasia by IVUS, and no cases of ST and MACE at 3 months follow-up.

Barry T Katzen (Baptist Cardiac and Vascular Institute, FL, USA) reported 1-year clinical outcomes of the FIM Assessment of The Latest Non-Thrombogenic Angioplasty stent (ATLANTA) trial evaluating the Catania Coronary Stent System with Nanothin Polyzene-F in de novo native coronary artery lesions. The CATANIA™ Coronary Stent System uses Polyzene^®-F, an inorganic polymer that bestows decreased thrombogenicity and biocompatibility [20]. It is these characteristics that make this stent particularly attractive for use in patients who are unable to be treated with long-term dual antiplatelet therapy. Among 55 patients, 6-month late lumen loss was 0.60 ± 0.48 mm and the percent neointimal hyperplasia volume was 27.9 ± 16.1%. In patients analyzed by OCT, 99.5% of struts were covered and only 0.15% of struts were malapposed. Binary angiographic restenosis was 6.8%. The incidence of clinically driven TLR at 12 months was only 3.6%, with no cases of fatalities, MI or ST. In the ATLANTA II prospective registry of high-risk population, there were low 10-month rates of cardiac death (1.6%), MI (0.5%), ST (1.5%) and TLR (6%), along with excellent stent healing by IVUS and OCT with only 1 month of dual antiplatelet therapy. Implantation of stents for the treatment of tibial arteries also showed promising results. Alessandro S Bortone (University of Bari School of Medicine, Bari, Italy) gave an update on the cobalt chromium MarTyN stent coated with titanium nitrate (TiN), an inert, biocompatible material that creates a thin physical barrier to the diffusion of toxic metal atoms. The multicenter prospective randomized single blinded study will assess the safety and effectiveness of the TiN-coated MAR-Tyn stent compared with an uncoated control cobalt chromium balloon-expandable stent (Vision^®, Abbott Vascular, UK).

The 5-year outcomes of patients treated with the TITAN-2^® stent (Hexacath, France) in the PORI registry [21] were reported by Pasi Karjalainen (Pori, Finland). Treatment with the TITAN-2 stent as opposed to the Taxus stent had lower rates of TLR (6.0 vs 10.3%, respectively; p = 0.2), and significantly lower rates of MI (9.5 vs 20.6%; p = 0.002) and MACE (16.9 vs 20.6%; p = 0.03). There were no cases of ST in patients treated with TITAN versus 7.8% of cases in the Taxus group. At 3-year follow-up in a randomized trial of patients with STEMI treated with primary PCI, the TITAN-2 stent versus the Taxus-Liberte^® stent was associated with similar rates of TLR (10.9 vs 9.8%,%, respectively; p = 0.75) but significantly lower rates of MI (6.1 vs 16.6; p < 0.001), cardiac death (1.4 vs 5.2%; p = 0.03), MACE (13.1 vs 23.7%; p = 0.003) and ST (0.5 vs 6.6%; p < 0.001). The ongoing BASE-ACS study will compare outcomes of 1050 patients with ACS randomized to treatment with the TITAN-2 stent versus XIENCE V/Promus^® (Boston Scientific, MA, USA) everolimus-eluting stent.

Dariusz Dudek (Institute of Cardiology, Krakow, Poland) reported preliminary outcomes from the MGuard™ (InspireMD, Ltd, Tel-Aviv, Israel) in Acute Myocardial (MAGICAL) trial that assessed the safety and efficacy of the MGuard stent in a prospective multicenter study designed to assess the feasibility, safety and efficacy of MGuard in patients undergoing primary PCI for STEMI [22]. The MGuard stent is wrapped with the ultra-thin polymer mesh sleeve that is designed for maximal flexibility without compromising the strength of the fiber. The sleeve expands seamlessly when the stent is deployed, without affecting the structural integrity of the stent. The two primary end points of the study are the complete resolution of ST-segment elevation and the restoration of the Thrombolysis in Myocardial Infarction (TIMI) study flow grade 3 in the infarct-related artery. At the time of the ICI meeting, the study had completed enrolment (n = 60 patients) and 6-month follow-up. No major adverse cardiac and cerebrovascular events were observed at 30 days and 6 months. Post procedure, 90% of the patients had TIMI flow grade 3, 73% of the patients had myocardial blush grade 3 and 61% of the patients had complete (>70%) ST-segment resolution. Among a subgroup of patients in whom PCI was performed without the use of aspiration catheters (n = 49), 91.8% of the patients had TIMI flow grade 3, 73.3% had myocardial blush grade 3 and 61.4% had complete (>70%) ST-segment resolution.

The state of drug-eluting balloons

The local delivery of a drug by coated balloon catheters can inhibit the proliferation of neointimal cells and prevent restenosis in both de novo and restenotic lesions. Rick Geoffrion (Invatec, Frauenfeld, Switzerland) provided a comprehensive overview on the role of drug-eluting balloons in contemporary PCI. Leonhard Bruch (Unfallkrankenhaus, Berlin, Germany) summarized data from the SeQuent^® Please balloon program. The balloon is manufactured using Matrix Coating PACCOCATH technology [23] that creates a unique matrix coating. This extensive clinical program assesses the outcomes of patients treated with drug-eluting balloons in different clinical and angiographic scenarios, including small vessels, in-stent restenosis, complex lesions, bifurcation lesions and chronic total occlusions.

Bifurcation lesions

Ioannis Iakovou (Onassis Cardiac Surgery Center, Athens, Greece) and Gary Gershony (John Muir Medical Center, CA, USA) provided an update on the treatment of bifurcation lesions that comprise 20–25% of PCI cases. Gary Gershony shared his experience on the treatment of bifurcation lesions with the AngioSculpt balloon, pointing out that this device facilitates stent delivery to main branch, optimizes stent expansion and apposition, as well as minimizing plaque shifting and loss of side branch. All this results in decreased need for side branch stenting and lower rates of final kissing balloon, device slippage and ‘geographic miss’. The coronary bifurcation AGILITY study is a prospective multicenter single-arm trial that is currently enrolling patients and is addressing the efficacy of the AngioSculpt alone strategy for the side branch in combination with DESs for the main branch. Preliminary analysis shows only a 4.1% rate of 30-day MACE (death, MI or TLR).

Stefan Hoffmann (Vvantes Klinikum im Friedrichshain, Berlin, Germany) reported on the use of the Glider™ Balloon Catheter, which results in optimizing the carina and ostium. This device is also advantageous due to its easily torqueable shaft allowing precise balloon tip orientation, atraumatic skived tip that avoids catching on stent struts and facilitates recrossing in side branch, and short asymmetric balloon with a low profile as well as with improved crossability. Chaim Lotan (Hadassah-Hebrew University Medical Center, Israel) summarized their experience on the use of the Antares^® Stent System to treat bifurcation lesions. The system has a single balloon and side branch wire lumen that allows the placement of wire to maintain constant side branch access and peel away that prevents wire wrap, an ostial preservation structure to improve ostial coverage, asymmetric ‘wings’ to allow the treatment of all side branch angulations, and radiopaque markers to facilitate precise side branch stent placement if needed. Postmarketing evaluation of the device in 60 patients with bifurcation lesions treated by 18 operators showed 100% postprocedure patency of main and side branches, along with a very low mean procedural time (22 min), which is lower than in historical controls. The device may be successfully used in combination with the Glider Balloon Catheter.

The year 2009 was the year of TAVI. Live transmission of TAVI was coordinated by a special group of TAVI pioneers, including Alain Cribier, Patrick Serruys, Martin Leon (Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA) and Jean-Claude Laborde (Clinique Pasteur, Toulouse, France). Current practice and future perspectives were discussed, as well as new solutions for other structural pathologies, such as mitral insufficiency, patent foramen ovale and left atrial appendage occlusion for the prevention of atrial fibrillation.

In parallel with the technology parade and the extensive clinical sessions that covered the latest information in coronary, peripheral and structural heart disease, a special summit was dedicated to cardiac regeneration. Discussions were held on the future of cardiovascular healing and repair, cell therapy and tissue engineering, in an attempt to illustrate the construction of a new heart. A special summary of the lectures given during the ICI cardiac regeneration summit is due shortly.

Conclusion

The ICI meeting once again proved to be a stimulating and exciting arena for future devices and technologies, in which innovation is in continuous motion in the everlasting combat with cardiovascular disease.

Financial & competing interests disclosure

Rafael Beyar is a founder and stock holder of Corindus Vascular Robotics, Natick, MA, USA. Chaim Lotan is a medical director of InspireMD, Ltd, Tel-Aviv, Israel. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.