Radosław Parma

Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve Regurgitation

OBJECTIVES This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable BACKGROUND Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. METHODS Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. RESULTS A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). CONCLUSIONS This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.

Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): A randomised, open-label, multicentre trial

BACKGROUND Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT). METHODS In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. FINDINGS Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (pnon-inferiority=0·0004; hazard ratio [HR] 0·81 [95% CI 0·62-1·06], psuperiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; pnon-inferiority=0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%) in the control group (HR 0·82 [95% CI 0·59-1·13]; p=0·23). INTERPRETATION Guided de-escalation of antiplatelet treatment was non-inferior to standard treatment with prasugrel at 1 year after PCI in terms of net clinical benefit. Our trial shows that early de-escalation of antiplatelet treatment can be considered as an alternative approach in patients with acute coronary syndrome managed with PCI. FUNDING Klinikum der Universität München, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo.

Early Translation of Adipose-Derived Cell Therapy for Cardiovascular Disease

Over the past decade, cell therapy has emerged as a new approach to reversing myocardial ischemia. Several types of adult stem cells have been studied in both preclinical and clinical conditions for this purpose: bone marrow cells, circulating cells, and myoblasts. Nevertheless, the quest for the ideal “anti-ischemic” cell is still ongoing. Recently, the existence of a population of stem cells located in adipose tissue (adipose-derived stem cells) has been observed. These are able to differentiate into multiple cell lineages including cardiomyocytic differentiation. In this review we discuss the basic principles of adipose-derived stem cells (types and characteristics, harvesting, and expansion), the initial experimental studies, and the currently ongoing clinical trials.

Adipose Tissue-derived Stem Cells: The Friendly Side of a Classic Cardiovascular Foe

Recently, the existence of a population of stem cells located in the adipose tissue has been observed. Adipose-derived stem cells are able to differentiate into multiple cell lineages including cardiac myocytes. Hence, adipose-derived cells are emerging as a new source of adult stem cells for cardiovascular repair. In this review, we discuss the basic principles of adipose-derived stem cells (types and characteristics, obtention processes, immunophenotypic characterization, and cell potency), the initial experimental studies, and the currently ongoing clinical trials.

Pre-procedural dual antiplatelet therapy and bleeding events following transcatheter aortic valve implantation (TAVI)

INTRODUCTION Transcatheter aortic valve implantation (TAVI) is associated with bleeding that increases mortality. Dual antiplatelet therapy (DAPT) is recommended in TAVI, however little is known about pre-procedural DAPT use and its impact on hemostasis. We sought to determine the frequency, predictors and bleeding events in patients receiving DAPT before TAVI. METHODS Three-hundred-and-three (n=303, 78.6±7.6years, 49% female, EuroScore 23.1±16.9) consecutive patients undergoing TAVI were prospectively analyzed and followed for in-hospital events. According to pre-procedural antiplatelet status study population was divided into 2 groups: patients receiving aspirin and clopidogrel (DAPT) and those on aspirin only or no antiplatelet therapy (noDAPT). RESULTS Pre-procedural DAPT was used in 139 cases (46%). Previous PCI (OR 4.8, [2.8-8.3], p<0.0001), implantation of self-expandable prosthesis (OR 2.2, [1.2-4], p=0.007) femoral access (OR 2.2, [1.1-4.5], p=0.029) and platelet count (OR 1.006, [1.002-1.01], p=0.002) were identified as independent predictors of pre-procedural DAPT. No difference was observed in the rates of any bleeding (23% in DAPT vs. 24.4% in noDAPT, p=0.930) or major/life-threatening bleeding (12.2% in DAPT vs. 14.7% in noDAPT, p=0.715). Propensity-score matching analysis did not alter the results. GFR <30ml/min was the strongest predictor of bleeding (OR 4.3, [1.9-9.9], p=0.0005). There was a trend towards lower frequency of MI and stroke/TIA in DAPT as compared with noDAPT (3.6% vs. 9.8%, p=0.082). CONCLUSIONS Pre-procedural DAPT is frequent and does not increase short-term bleeding complications or need for transfusion following TAVI. Possible impact of DAPT use before TAVI on ischemic complications needs to be investigated in larger populations.

Percutaneous interventions in cardiology in Poland in the year 2014. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society AISN PTK.

Introduction The Board of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) publishes annual data from the National PCI Registry (ORPKI) operated by the Jagiellonian University Medical College in Krakow. Aim For the first time the AISN PTK report is based on the new electronic database implemented in Poland on January 1st, 2014. Material and methods In 2014, there were 155 invasive cardiology centers registered in the ORPKI database (an increase by 1 center in comparison to 2013) and 92% of them had 24/7 percutaneous (PCI) duty. For the first time the number of catheterization laboratories (cath labs) in Poland remained stable, and even though there was an increase by 1 in absolute numbers, 2 cath labs ceased to admit patients in 2014. This means that the number of active cath labs per 1 million inhabitants is similar to last year and equals 4. Results In comparison to 2013, there was a significant increase in the total number of coronary angiographies. There were 226 713 angiographies in 2014. The total number of PCI procedures was 126 241, which is 5.1% more than in 2013. Conclusions There was a significant increase in the overall number of coronary angiographies and PCIs in Poland in 2014. The use of attributes of modern interventional cardiology such as drug-eluting stents and bioabsorbable vascular stents is growing as well as more frequent choice of a radial access site by PCI operators even in ST-elevation myocardial infarction patients. One should also note a significant rise in the use of additional imaging or diagnostic tools such as fractional flow reserve, intravascular ultrasound and optical coherent tomography.

Age and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients undergoing percutaneous coronary intervention: results from the randomized TROPICAL-ACS trial

Aims Guided de-escalation of P2Y12-inhibitor treatment was recently identified as an effective alternative treatment strategy in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention. Safety and efficacy of this strategy may differ in relation to patients age. This pre-specified analysis of the TROPICAL-ACS trial aimed to assess the impact of age on clinical outcomes following guided de-escalation of antiplatelet treatment in ACS patients. Methods and results Patients were randomly assigned in a 1:1 fashion to either standard treatment with prasugrel for 12 months (control group) or to a guided de-escalation regimen (1 week prasugrel followed by 1 week clopidogrel and platelet function testing guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). We used Cox regression models to assess the associations of age on clinical endpoints and interactions. In younger patients (age ≤70, n = 2240), the 1 year incidence of the primary endpoint (cardiovascular death, myocardial infarction, stroke, or bleeding ≥ grade 2 according to Bleeding Academic Research Consortium criteria) was significantly lower in guided de-escalation vs. control group [5.9% vs. 8.3%; hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.51-0.96; P = 0.03, number needed to treat = 42]. In elderly patients (age >70, n = 370), the absolute risk of events was higher without significant differences between guided de-escalation vs. control group (15.5% vs. 13.6%; HR 1.17, 95% CI 0.69-2.01; P = 0.56). When the impact of age, as a continuous variable, was analysed on outcomes after guided de-escalation vs. control treatment, an increasing relative risk reduction was observed in the primary endpoint by decreasing age (Pint = 0.02), due to significant reductions in bleeding. Conclusion Treatment effects of guided de-escalation for P2Y12 inhibitors depend on patients age with younger patients deriving a significant net clinical benefit. Although the safety and efficacy of guided de-escalation in the elderly was similar to uniform prasugrel therapy, this should be further investigated due to the limited sample size of this group.

The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland

Introduction Few studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing. Aim To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. Material and methods The Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively). Results The median TAVI experience per centre was 80 procedures (95% CI: 38.1–154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each. Conclusions The PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

Percutaneous interventions in cardiology in Poland in 2014. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK)

1Zakład Kardiologii Interwencyjnej, Górnośląskie Centrum Medyczne, Katowice-Ochojec 2Klinika Kardiologii Interwencyjnej, Instytut Kardiologii, Uniwersytet Jagielloński, Collegium Medicum, Kraków 3II Klinika Kardiologii, Instytut Kardiologii, Uniwersytet Jagielloński, Collegium Medicum, Kraków 4Instytut Kardiologii, Warszawa-Anin 5Klinika Kardiologii, Uniwersytet Medyczny w Białymstoku, Białystok 6I Klinika Kardiologii, Uniwersytet Medyczny, Poznań 7Klinika Kardiologii Dziecięcej, Uniwersytet Medyczny, Poznań 8Klinika Kardiologii Inwazyjnej, CSK MSWiA, Warszawa

Statistics regarding interventional cardiology in Poland in 2013. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK)

1Department of Interventional Cardiology, GCM, Katowice, Poland 22nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland 3Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland 43rd Division of Cardiology, Medical University of Silesia, Katowice, Poland 5Institute of Cardiology, Warsaw, Poland 6Medical University in Bialystok, Poland 7Medical University in Poznan, Poland 8Department of Invasive Cardiology, Warsaw, Poland