Percutaneous Cardiovascular Interventions Research Articles

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Robotic technology in interventional cardiology: Current status and future perspectives

Robotic technology has been utilized in cardiovascular medicine for over a decade, and over that period, its use has been expanded to percutaneous coronary and peripheral vascular interventions. The safety and feasibility of robotically assisted percutaneous cardiovascular interventions has been demonstrated in studies including simple to complex coronary lesions, and both iliac and femoropopliteal lesions. These reports have shown that robotically assisted PCI significantly reduces operator exposure to harmful ionizing radiation without a detrimental effect on procedural success or clinical efficacy. Additionally, the use of robotics has the intuitive benefit of alleviating the risk of orthopedic injuries faced by interventional operators. In addition to the interventional operator benefits, robotically assisted intervention has the potential for patient level benefit by allowing more accurate lesion length measurement, precise stent placement, and lower patient radiation exposure. However, further investigation is required to fully elucidate these potential benefits.

Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

IntroductionThe findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016.MethodsThe authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice.ResultsA total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation).ConclusionThis paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

Serbia: coronary and structural heart interventions from 2010 to 2015.

Serbia's interventional community has been facing the multifaceted challenge of an ageing population with cardiovascular diseases as the primary cause of death nationwide, coronary artery disease (CAD) being the most prevalent subset. The following two fields of activity have marked the trajectory of progress in the field of interventional cardiology in Serbia: first, the expansion of the infrastructure, mainly through the opening of new catheterisation laboratories across all of the country's administrative regions, which has resulted in better accessibility to coronary interventions for the general population; second, the creation of national platforms for continuous education, training and the promotion of clinical research in interventional cardiology, with close programmatic links to European Association of Percutaneous Cardiovascular Interventions (EAPCI)-based educational initiatives, including the curriculum for interventional cardiology. As growth seems to be inherent to the concept of progress, we report here on the expanding numbers of coronary interventions in the period between January 2010 and December 2015, and the early experiences with structural heart interventions in Serbia.

Analysis of percutaneous coronary interventions in a 10-year period (2005-2015) - a single center experience.

Background: Medicor was established as the third cardiovascular center in Slovenia and started with percutaneous cardiovascular interventions in 2005. The purpose of our study was to describe the features and results of percutaneous coronary intervention (PCI) performed between 2005 and 2015. Methods: Our retrospective descriptive study included consecutive patients undergoing PCI, who were enrolled in the PCI Registry. Patient characteristics, coronary anatomy, PCI features, use of coronary stents, procedural success and complications were investigated. Special emphasis was put on patients undergoing unprotected left main PCI. Results: During the study period, 1981 PCI procedures were performed. PCI patients were mainly men (73 %), their average age was 65+10 years and a majority (94 %) had stable coronary disease with mutivessel involvement (62 %). PCI was performed on 2978 lesions (1.50 lesion/patient) with an average diameter stenosis of 85+10 %. Target lesion was located either in the left anterior descending artery (42.9 %), right coronary artery (32.4 %), left circumflex artery (18.4 %), left main (3 %), surgical grafs (2.3 %) or in the intermediate artery (1 %). Balloon angioplasty alone was used in 9.6 % while other patients received 1 to 7 stents (1.44+0.86 per patient). Until 2009, drug eluting stents (DES) penetration ranged between 20 % and 30 %. It then increased to 80 % in 2012 and 100 % in 2015. PCI was angiographically successful in 95.2 %. Because of PCI complications, 4 patients (0.2 %) required immediate open-heart surgery and 4 patients (0.2 %) a surgical intervention at the femoral access site. Hospital mortality was 0 %. Stent thrombosis within 30 days was documented in 6 patients (0.3 %). In a subgroup of 58 patients undergoing unprotected lef main PCI, provisional stenting was used in 88 %. DES penetration was 94 %. PCI was angiografcally successful in all patients. Hospital and 30-day mortality rates were 0 %, 1-year mortality 1.7 % (95 % confidence interval 0–11 %) and 5-year mortality 13.8 % (95 % confidence interval 7–33 %). Target vessel revascularization at 5 years was 3.5 % (95 % confidence interval 0–23 %). Conclusion: PCI in patients with predominantly stable coronary artery disease in the Medicor Cardiovascular Center appears to be an effective and safe method of revascularization, which is also true for an intervention in unprotected left main.

Analiza izvajanja perkutanih koronarnih posegov v 10-letnem obdobju (2005–2015) – izkušnje enega centra

Background: Medicor was established as the third cardiovascular center in Slovenia and started with percutaneous cardiovascular interventions in 2005. The purpose of our study was to describe the features and results of percutaneous coronary intervention (PCI) performed between 2005 and 2015.Methods: Our retrospective descriptive study included consecutive patients undergoing PCI, who were enrolled in the PCI Registry. Patient characteristics, coronary anatomy, PCI features, use of coronary stents, procedural success and complications were investigated. Special emphasis was put on patients undergoing unprotected left main PCI.Results: During the study period, 1981 PCI procedures were performed. PCI patients were mainly men (73 %), their average age was 65+10 years and a majority (94 %) had stable coronary disease with mutivessel involvement (62 %). PCI was performed on 2978 lesions (1.50 lesion/patient) with an average diameter stenosis of 85+10 %. Target lesion was located either in the left anterior descending artery (42.9 %), right coronary artery (32.4 %), left circumflex artery (18.4 %), left main (3 %), surgical grafs (2.3 %) or in the intermediate artery (1 %). Balloon angioplasty alone was used in 9.6 % while other patients received 1 to 7 stents (1.44+0.86 per patient). Until 2009, drug eluting stents (DES) penetration ranged between 20 % and 30 %. It then increased to 80 % in 2012 and 100 % in 2015. PCI was angiographically successful in 95.2 %. Because of PCI complications, 4 patients (0.2 %) required immediate open-heart surgery and 4 patients (0.2 %) a surgical intervention at the femoral access site. Hospital mortality was 0 %. Stent thrombosis within 30 days was documented in 6 patients (0.3 %). In a subgroup of 58 patients undergoing unprotected lef main PCI, provisional stenting was used in 88 %. DES penetration was 94 %. PCI was angiografcally successful in all patients. Hospital and 30-day mortality rates were 0 %, 1-year mortality 1.7 % (95 % confidence interval 0–11 %) and 5-year mortality 13.8 % (95 % confidence interval 7–33 %). Target vessel revascularization at 5 years was 3.5 % (95 % confidence interval 0–23 %).Conclusion: PCI in patients with predominantly stable coronary artery disease in the Medicor Cardiovascular Center appears to be an effective and safe method of revascularization, which is also true for an intervention in unprotected left main.

A cardiac catheterisation laboratory core curriculum for the continuing professional development of nurses and allied health professions: developed by the Education working group of the Nurses and Allied Professions Committee for the European Association of Percutaneous Cardiovascular Interventions (EAPCI) 2016.

The aim of this report is to provide a standard educational structure for nurses and allied professionals (NAP) specialising in interventional cardiology. The curriculum can also be used as a basis for training on a certificate-based level in interventional cardiology. The curriculum was developed by a panel of experts from various allied health professions. The syllabus focuses on nine core areas of themes essential for NAP working in interventional cardiology. The highly technical knowledge required for working in interventional cardiology as well as the various roles of the different professional groups have been taken into consideration. This core curriculum will ensure that essential content is covered during education and a basic level of quality is achieved across specialty cardiovascular educational programmes throughout Europe.

Carlo Di Mario moves from London to Florence.

Di Mario briefly discusses his return to roots with CardioPulse ![Graphic][1] In September 2016 Carlo Di Mario left his position as Professor of Clinical Cardiology at Imperial College and Consultant Cardiologist at the Royal Brompton Hospital in London to return to Italy and accept the Chair of Cardiology at the University of Florence and the Directorship of the Division of Structural Interventional Cardiology of the. Carlo a native Italian, graduated in Italy but completed his interventional training and PhD at the Erasmus University of Rotterdam with Patrick Serruys, then returned to the San Raffaele Hospital in Milan with Antonio Colombo to move again to London in 2003. CardioPulse has already interviewed him in the past, when he was President of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), to understand the obstacles cardiologists face moving across Europe. CardioPulse: What made you … [1]: /embed/inline-graphic-1.gif

Assessing the cardiology community position on transradial intervention and the use of bivalirudin in patients with acute coronary syndrome undergoing invasive management: results of an EAPCI survey.

Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) collecting the opinion of the cardiology community on the invasive management of acute coronary syndrome (ACS), before and after the MATRIX trial presentation at the American College of Cardiology (ACC) 2015 Scientific Sessions. A web-based survey was distributed to all individuals registered on the EuroIntervention mailing list (n=15,200). A total of 572 and 763 physicians responded to the pre- and post-ACC survey, respectively. The radial approach emerged as the preferable access site for ACS patients undergoing invasive management with roughly every other responder interpreting the evidence for mortality benefit as definitive and calling for a guidelines upgrade to class I. The most frequently preferred anticoagulant in ACS patients remains unfractionated heparin (UFH), due to higher costs and greater perceived thrombotic risks associated with bivalirudin. However, more than a quarter of participants declared the use of bivalirudin would increase after MATRIX. The MATRIX trial reinforced the evidence for a causal association between bleeding and mortality and triggered consensus on the superiority of the radial versus femoral approach. The belief that bivalirudin mitigates bleeding risk is common, but UFH still remains the preferred anticoagulant based on lower costs and thrombotic risks.

Should endovascular approach be the first line of treatment for retroperitoneal bleeding with hemodynamic shock following percutaneous intervention? A case series.

To report a series of consecutive patients that developed retroperitoneal hemorrhage (RPH) and persistent hypotension treated with endovascular approach. RPH is a rare complication of percutaneous cardiovascular interventions associated with high morbidity and mortality. The standard approach to treat this complication has been a conservative management for stable patients, and urgent vascular surgery for those with persistent hypovolemic shock. Percutaneous endovascular treatment has evolved as an alternative treatment option. We implemented a management algorithm for patients with suspected RPH and persistent hypotension which embraced systematic use of emergency endovascular evaluation and treatment following clinical assessment without the use of non-invasive diagnostic testing. We report a series of 8 consecutive patients that developed RPH with persistent hypotension. Successful percutaneous treatment was achieved in all cases with the use of a covered stent. No patient required vascular surgery. The average blood transfusion was 3.4 ± 2.7 units per patient. There were no deaths; one patient experienced acute stent thrombosis that was successfully treated via endovascular approach. At 1-year follow-up, no further events were reported. The incorporation of a standardized protocol using only clinical evaluation followed by emergency percutaneous approach without delays attributed to non-invasive diagnostic work-up showed to be feasible and associated with favorable outcomes. © 2016 Wiley Periodicals, Inc.

Bioresorbable Vascular Scaffolds as Optimal Treatment for Selected Patients in our Clinical Practice

Bioresorbable vascular scaffolds (BRS)/bioabsorbable stents are a new and promising generation of intravascular devices that may potentially circumvent many of the problems associated with permanent metallic stents for coronary artery bypass graft surgery. The ABSORB™ BRS (Abbott Vascular, Santa Clara, California, USA) received Conformité Européenne (CE) mark approval in 2011 and has been implanted in over 150,000 patients over the globe. New ABSORB data was presented at the 2016 EuroPCR Congress held in Paris, France, from 17th–20th May 2016. EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), with the goal of reducing the burden of cardiovascular disease. We conducted an interview with four leading interventional cardiologists to discuss the prospective implications and advantages to patients generated by the development of such a technology, and how their experience in daily surgical practice is reflective of the device characteristics and features, which are interesting for select patient subsets.

Targeting percutaneous cardiovascular interventions at all who will benefit the most: The reality of the Eastern European countries

Targeting percutaneous cardiovascular interventions at all who will benefit the most: The reality of the Eastern European countries

Periprocedural antithrombotic therapy during various types of percutaneous cardiovascular interventions.

Percutaneous catheter-based interventions became a critically important part of treatment in modern cardiology, improving quality of life as well as saving many life. Due to the introduction of foreign materials to the circulation (either temporarily or permanently) and due to a certain damage to the endothelium or endocardium, the risk of thrombotic complications is substantial and thus some degree of antithrombotic therapy is needed during all these procedures. The intensity (dosage, combination, and duration) of periprocedureal antithrombotic treatment largely varies based on the type of procedure, clinical setting, and comorbidities. This manuscript summarizes the current therapeutic approach to prevent clotting (and bleeding) during a large spectrum of interventions: acute and elective coronary interventions, acute stroke interventions and elective carotid stenting, electrophysiology procedures, interventions for structural heart disease, and peripheral arterial interventions.

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

Update on the WOMEN Initiative to Address Gender Inequalities in Interventional Cardiology

The WOMEN Initiative of the European Association of Percutaneous Cardiovascular Interventions has been launched to understand gender disparities in access to interventional cardiology care, increase the number of women who become an interventional cardiologist or researcher, and increase awareness about gender inequality within the interventional and research communities.

Mapping interventional cardiology in Europe: proceedings of the 3rd Summit of the European Association of Percutaneous Cardiovascular Interventions.

Mapping interventional cardiology in Europe: proceedings of the 3rd Summit of the European Association of Percutaneous Cardiovascular Interventions.

A Review of the Key Clinical Trials of 2014.

IntroductionOver the last year, multiple, potentially practice-changing, cardiology trials or studies have been published or presented at international meetings including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Failure Congress, Heart Rhythm Society, Heart Failure Society of America, American Society of Hypertension and the American Heart Association.MethodsClinical trial results presented at major cardiology conferences during 2014 were reviewed by the authors. Search terms included heart failure (HF), acute coronary syndrome, stable coronary disease, interventional cardiology, atrial fibrillation, electrophysiology and coronary prevention. Selection criteria were trials of broad relevance to the cardiology community, those with potential to change current practice and those with potential to guide further phase III research.ResultsIn this paper, the authors describe and place in clinical context, new HF, data including neprilysin inhibitors, intravenous ferric carboxymaltose, potassium-absorbing compounds, quadripolar leads for cardiac resynchronization therapy and intraventricular device intervention. New trial data are also described for acute coronary syndromes (clopidogrel, prasugrel, ticagrelor), stable coronary artery disease (ivabradine), percutaneous coronary intervention (the role of thrombectomy or treatment of non-culprit lesions during primary intervention, pressure wire studies and outcomes of new stent designs), transcatheter aortic valve intervention data, atrial fibrillation (anticoagulation and direct current cardioversion), electrophysiology (leadless pacemaker devices, use of quinidine in Brugada syndrome) and coronary prevention (landmark Ezetimibe outcome data, PCSK9 clinical trials, childhood prevalence of hypertension, renal denervation for resistant hypertension and the role of cardiac computerized tomography in cardiovascular screening).ConclusionThis paper summarizes key clinical trials during 2014 and should be of practical interest to clinicians and cardiology researchers.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-015-0036-0) contains supplementary material, which is available to authorized users.

Double or triple antithrombotic combination therapy in patients who need anticoagulation and antiplatelet therapy in parallel.

The optimal strategy to balance bleeding and ischaemic events in patients with atrial fibrillation, requiring antiplatelet therapy on top of anticoagulation, is subject to debate, since specifically designed and powered randomized trials are not available yet. The review aims to highlight the current developments in the light of the 2014 joint consensus document of the European Society of Cardiology (ESC) Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS) and of the 2014 ESC myocardial revascularization guidelines, both published recently.