Vol 26, No 2 (2019)
Review articles — Clinical cardiology
Published online: 2019-02-07
Recommendations on the use of innovative medical technologies in cardiology and cardiac surgery and solutions leading to increased availability for Polish patients
Abstract
There is a great need for innovative technologies that will improve the health and quality of life (QoL) of Polish patients with cardiac problems. It is important that the safety and effectiveness of the technology are confirmed by scientific evidence on which guidelines and clinical recommendations are based. Scientific evidence for medical devices is also increasingly important for decision-making in finance approval from public funds. New technologies in cardiology and cardiac surgery contribute to improved patient QoL, increased treatment effectiveness and facilitated diagnosis. Hence, it is necessary to increase accessibility to such technologies, primarily through the development of clinical recommendations, and education of medical personnel in conjunction with public funding. The aim of this publication is to present the recommendations of leading experts in the field of cardiology and cardiosurgery, supported by clinical research results, regarding the use of the cited innovative medical technologies and solutions leading to their increased availability for Polish patients.
Keywords: coronary angioplastyoptical coherence tomographyheart failureimplantable loop recordermitral regurgitationventricular assist systempulmonary artery pressure
References
- Straburzyńska-Migaj E, Nessler J, Gackowski A, et al. Niewydolność serca w Polsce – raport 2016. Sekcja Niewydolności Serca Polskiego Towarzystwa Kardiologicznego. 2016.
- Gierczyński J, Wróblewski T, Gilewski M. Priorytety zdrowotne w kontekście demograficznego i gospodarczego rozwoju Polski. Wnioski i rekomendacje na przykładzie niewydolności serca. Raport Warsaw Enterprise Institute. Warszawa. 2018.
- Skóra K. Od pieluchomajtek po rozruszniki serca. Menedżer Zdrowia. 2018; 2: 65–68.
- Mechaniczne wspomaganie serca sztucznymi komorami AOTMiT-WT-553-2/2015 Raport w sprawie ustalenia taryfy świadczeń. 8/49.
- Nessler J, Kozierkiewicz A, Gackowski A, et al. [Coordinated heart failure care in Poland: towards optimal organisation of the health care system]. Kardiol Pol. 2018; 76(2): 479–487.
- Ponikowski P, Voors A, Anker S, et al. Wytyczne ESC dotyczące diagnostyki i leczenia ostrej i przewlekłej niewydolności serca w 2016 roku. Kardiol Pol. 2016; 74(10): 1037–1147.
- Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001; 345(20): 1435–1443.
- Dembitsky WP, Tector AJ, Park S, et al. Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial. Ann Thorac Surg. 2004; 78(6): 2123–2130.
- Estep JD, Starling RC, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP). J Heart Lung Transplantat. 2015; 34(4): S80.
- Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) - 2 Year Results. J Heart Lung Transplantat. 2016; 35(4): S22.
- Stehlik J, Estep JD, Selzman CH, et al. Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Circ Heart Fail. 2017; 10(6).
- Morshuis M, Garbade J, Zimpfer D, et al. Clinical Outcomes with Heartmate 3 TM Left Ventricular Assist Device as Treatment for Advanced Heart Failure: 12-Month Outcomes from the ELEVATE Registry. J Heart Lung Transplantat. 2018; 37(4): S84.
- Heatley G, Sood P, Goldstein D, et al. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant. 2016; 35(4): 528–536.
- Mehra MR, Naka Y, Uriel N, et al. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017; 376(5): 440–450.
- Cowger JA, Naka Y, Aaronson KD, et al. Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. J Heart Lung Transplant. 2018; 37(1): 15–24.
- Uriel N, Colombo P, Cleveland J, et al. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months. Circulation. 2017; 135(21): 2003–2012.
- Mehra MR, Goldstein DJ, Uriel N, et al. MOMENTUM 3 Investigators. Two-Year outcomes with a magnetically levitated cardiac pump in heart failure. N Engl J Med. 2018; 378(15): 1386–1395.
- Mehra M, Salerno C, Cleveland J, et al. Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study. Circulation. 2018; 138(18): 1923–1934.
- Zarządzenie Nr 99/2017/DSOZ Prezesa Narodowego Funduszu Zdrowia z dnia 29 września 2017 r. zmieniające zarządzenie w sprawie określenia warunków zawierania i realizacji umów w rodzaju leczenie - świadczenia.
- Budnik M. Parametry badania echokardiograficznego pomocne w kwalifikacji do zabiegu MitraClip. Folia Cardiologica. 2016; 11(5): 487–490.
- Sukiennik, A. Zabieg przezskórnej naprawy niedomykalnej zastawki mitralnej za pomocą systemu MitraClip (Abbott). Folia Cardiologica. 2010; 5. ; 5: 274–282.
- Alfieri O, Maisano F, De Bonis M, et al. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. 2001; 122(4): 674–681.
- https://radioklinika.pl/kardiologia-tavi-i-mitraclip/ (access: 15.06.2018).
- Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol. 2017; 70(19): 2315–2327.
- Grasso C, Capodanno D, Scandura S, et al. One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J Cardiol. 2013; 111(10): 1482–1487.
- Attizzani GF, Ohno Y, Capodanno D, et al. Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry. JACC Cardiovasc Interv. 2015; 8(1 Pt A): 74–82.
- Puls M, Lubos E, Boekstegers P, et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J. 2015; 37(8): 703–712.
- Sürder D, Pedrazzini G, Gaemperli O, et al. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart. 2013; 99(14): 1034–1040.
- Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med. 2018; 379(24): 2297–2306.
- Stone G, Lindenfeld J, Abraham W, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018; 379(24): 2307–2318.
- http://bipold.aotm.gov.pl/assets/files/zlecenia_mz/2012/119/SRP/U_10_152_130415_stanowisko_61_MitraClip.pdf (access: 30.07.2018).
- Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Curr Heart Fail Rep. 2009; 6(4): 287–292.
- Adamson PB, Abraham WT, Aaron M, et al. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. J Card Fail. 2011; 17(1): 3–10.
- Desai A, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “real-world” clinical practice. J Am Coll Cardiol. 2017; 69(19): 2357–2365.
- Moya A, Sutton R, Ammirati F, et al. Wytyczne dotyczące diagnostyki i postępowania w omdleniach (wersja 2009). Grupa Robocza Europejskiego Towarzystwa Kardiologicznego (ESC) do spraw diagnostyki i postępowania w omdleniach. Kardiol Pol. 2009; 67.
- Brignole M, Moya A, de Lange FJ, et al. Practical Instructions for the 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018; 39(21): e43–e80.
- Priori S, Blomström-Lundqvist C, Mazzanti A, et al. Wytyczne ESC dotyczące postępowania u pacjentów z komorowymi zaburzeniami rytmu oraz zapobiegania nagłym zgonom sercowym w 2015 roku. Kardiol Pol. 2015; 73(10): 795–900.
- Kirchhof P, Benussi S, Kotecha D, et al. Wytyczne ESC dotyczące leczenia migotania przedsionków w 2016 roku, opracowane we współpracy z EACTS. Kardiol Pol. 2016; 74(12): 1359–1469.
- Grabowski M, Mitkowski P, Ochotny R, et al. First Polish implantations of the smallest minimally invasive implantable loop recorder. Kardiol Pol. 2015; 73(9): 781.
- Krahn AD, Klein GJ, Yee R, et al. Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial. J Am Coll Cardiol. 2003; 42(3): 495–501.
- Podoleanu C, DaCosta A, Defaye P, et al. Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study). Arch Cardiovasc Dis. 2014; 107(10): 546–552.
- Diamantopoulos A, Sawyer LM, Lip GYH, et al. Cost-effectiveness of an insertable cardiac monitor to detect atrial fibrillation in patients with cryptogenic stroke. Int J Stroke. 2016; 11(3): 302–312.
- Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. 2007; 49(19): 1951–1956.
- Davis S, Westby M, Pitcher D, et al. Implantable loop recorders are cost-effective when used to investigate transient loss of consciousness which is either suspected to be arrhythmic or remains unexplained. Europace. 2011; 14(3): 402–409.
- Wytyczne ESC dotyczące postępowania w stabilnej chorobie wieńcowej w 2013 roku. Kardiol Pol. 2013; 71(X): 243–318.
- Windecker S, Kolh P, Alfonso F, et al. Wytyczne ESC/EACTS dotyczące rewaskularyzacji mięśnia sercowego w 2014 roku. Kardiol Pol. 2014; 72(12): 1253–1379.
- Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2): 204–212.
- Pawłowski T. Aparat ILUMIEN — nowe możliwości optymalizacji zabiegów angioplastyki wieńcowej. Kardiol Inwaz. 2011; 6.2: 14–14.
- Prati F, Romagnoli E, Burzotta F, et al. Clinical Impact of OCT Findings During PCI. JACC: Cardiovascular Imaging. 2015; 8(11): 1297–1305.
- Ali ZA, Maehara A, Généreux P, et al. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016; 388(10060): 2618–2628.
