HYGEIA Hospital
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HYGEIA Hospital Tirana
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Transcatheter Heart Valves

Transcatheter Heart Valves

  • Transcatheter Heart Valves

Recognizing and appreciating the recent advances in the field, ΗYGEIA Hospital has established the first Transcatheter Heart Valve Department in Greece (and one of the first worldwide). The Department specializes in transcatheter aortic valve replacement and mitral valve insufficiency repair.

The experience of the Department staff exceeds 800 successful transcatheter aortic valve implantations, using all currently available valve types (SAPIEN 3, Edwards Lifesciences; CoreValve Evolut R, Medtronic; Portico, St Jude; JENA Valve) and all possible access routes (transfemoral, transaortic, transapical, subclavian).

The Department successfully introduced the MitraClip (Abbott Vascular) procedure for transcatheter repair of mitral valve insufficiency in Greece in 2011 and it runs the only such program in Greece.

All transcatheter procedures are performed in the state-of-the-art Hybrid Operating Room of HYGEIA Hospital.

The Transcatheter Heart Valve Department can perform all the diagnostic and therapeutic interventional cardiac procedures (coronary angiography, angioplasty and stenting, valvuloplasty, alcohol septal ablation, heart biopsy, pericardiocentesis, percutaneous closure of paravalvular leaks, etc).

The HYGEIA Hospital Transcatheter Heart Valve Department is an official training center for the Medtronic CoreValve and the medical staff are trainers for the companies Medtronic, Edwards, St Jude and Abbott Vascular.

Press Release

K Spargias, A Manginas, G Pavlides, M Khoury, G Stavridis, P Rellia, A Smirli, A Thanopoulos, M Balanika, S Polymeros, S Thomopoulou, G Athanassopoulos, G Karatasakis, R Mastorakou, S Lacoumenta, A Michalis, P Alivizatos, D Cokkinos. Transcatheter Aortic Valve Implantation: First Greek Experience. Hellenic J Cardiol 2008;49:397-407.

K, Chrissoheris M, Halapas A, Nikolaou J, Tsolakis A, Bouboulis N, Pattakos S. Percutaneous Mitral Valve Repair Using the Edge-to-Edge Technique: First Greek Experience. Hellenic J Cardiol 2012;53:343-51.

K Spargias, K Toutouzas, M Chrissoheris, Synetos A, Halapas A, Paizis I, Latsios G, Stahogianis K, Papametzelopoulos S, Zanos S, Pavlides G, Zacharoulis A, Antoniades A, Stefanadis C. The ATHENS TAVI Registry of newer generation transfemoral aortic valves. 30 day outcomes. Hellenic J Cardiol 2013;54:18-24.

Chrissoheris M, Ziakas A, Halapas A, Hadjimiltiades S, Styliadis I, Karvounis C, Nikolaou I, Spargias K. Acute Invasive Hemodynamic Effects of Transcatheter Aortic Valve Implantation. J Heart Valve Disease 2016, In press.

K Spargias, A Halapas, M Chrissoheris, N Bouboulis, S Skardoutsos, J Nikolaou, A Tsolakis, C Mourmouris, S Pattakos. Transaortic Aortic Valve Replacement Using The Edwards Sapien-XT Valve And The Medtronic Corevalve. Initial Experience. Hellenic J Cardiol 2014;55:288-93.

M Chrissoheris, A Tsangaris, A Halapas, K Spargias. Transcatheter Aortic Valve Replacement in Patients with Prior Chest Irradiation and Severe Aortic Stenosis. J Radiol Oncology 2016, In press.

Spargias K, Dvir D. TAVR In Failed Bioprostheses. The Valve-In-Valve Approach. Cardiac Interv Today 2013; 45-8.

Chrissoheris M, Halapas A, Nikolaou I, Boumboulis N, Pattakos S, Spargias K. The Abbott Vascular MitraClip: Patient Selection and How to Obtain the Best Outcomes. Hellenic J Cardiol. 2015;56 Suppl A:31-8.

Tzikas A, Chrissoheris M, Halapas A, Spargias K. PorticoTM Transcatheter Heart Valve. Hellenic J Cardiol. 2015;56 Suppl A:15-9.

Halapas A, Chrissoheris M, Bouboulis N, Skardoutsos S, Nikolaou I, Pattakos S, Spargias K. The SAPIEN-XT and SAPIEN-3 Valves: How to Implant and Obtain the Best Outcomes. Hellenic J Cardiol. 2015;56 Suppl A:9-14.

Spargias K. The era of transcatheter valve therapy. Where are we? Hellenic J Cardiol. 2015;56 Suppl A:1-3.

Wendler O, Walther T, Schroefel H, Lange R, Treede H, Fusari M, Rubino P, Thomas M; SOURCE investigators (K Spargias). Transapical aortic valve implantation: mid-term outcome from the SOURCE registry. Eur J Cardiothorac Surg 2013;43:505-11.

Spargias K, Tzifa A, Chrissoheris M, Boumpoulis N, Nikolaou I, Pattakos E. Transapical closure of mitral prosthetic paravalvular leak. Hellenic J Cardiol 2013;54:397-400.

A Halapas, M Chrissoheris, I Nikolaou, N Bouboulis, K Spargias. Challenging Transfemoral Valve-in-Valve Implantation in a Degenerated Stentless Bioprosthetic Aortic Valve. J Invasive Cardiol 2015;56:347-50

Papavasileiou LP, Halapas A, Chrisocheris M, Bellos K, Bouboulis N, Pattakos S, Spargias K, Apostolopoulos T. Sudden Death After ranscatheter Aortic Valve Implantation. Are Bradyarrhythmias Always The Cause? JAFIB. 2015;8:39-41.

K Spargias, G Dangas. Percutaneous Treatment of Left Side Cardiac Valves. C Tamburino and GP Ussia, Ed. Springer-Verlag, 2010, Milan, Italy.

Chrissoheris M, Spargias K. “Balloon Aortic Valvuloplasty” in Textbook: Cardiac Valvular Medicine. Rajamannan NM (Ed.). Springer-Verlag, 2013, London, UK.

Spargias K.
Percutaneous aortic valve implantation: present and future. Controlled clinical application before the results of randomized trials. Hellenic J Cardiol 2009;50:237-44.

K Spargias, M Gyöngyösi, R Hemetsberger, A Posa, N Pavo, IJ Pavo, K Huber, Z Petrasi, O Petnehazy, R Pogge von Strandmann, SR Stock, D Glogar, G Maurer, NM Rajamannan. Valvuloplasty with a Paclitaxel-Eluting Balloon Prevents Restenosis in an Experimental Model of Aortic Stenosis. J Heart Valve Disease 2014 Jul;23(4):484-91.

Spargias K, Polymeros S, Dimopoulos A, Manginas A, Pavlides G, Balanika M, Smirli A, Stavridis G, Dangas G, Cokkinos DV. The predictive value and evolution of N-Terminal Pro-B-Type Natriuretic Peptide levels following Transcutaneous Aortic Valve Implantation. J Interv Cardiol 2011;24:462-9.

Balanika M, Smyrli A, Samanidis G, Spargias K, Stavridis G, Karavolias G, Khoury M, Voudris V, Lacoumenta S. Anesthetic Management of Patients Undergoing Transcatheter Aortic Valve Implantation. J Cardiothorac Vasc Anesth 2013 Dec 5. [Epub ahead of print]

Spargias K, Alexopoulos E, Thomopoulou S, Dimopoulos A, Manginas A, Pavlides G, Voudris V, Karatassakis G, Athanassopoulos G, Cokkinos DV. Effect of balloon valvuloplasty in patients with severe aortic stenosis on levels of N-terminal pro-B-type natriuretic peptide. Am J Cardiol 2009;104:846-849.

Dvir D, Assali A, Spargias K, Kornowski R. Percutaneous aortic valve implantation in patients with coronary artery disease: review of therapeutic strategies. J Invasive Cardiol 2009;21:E237-41.

Chrissoheris M, Ferti A, Spargias K. Early prosthetic valve endocarditis complicating repeated attempts at CoreValve implantation. J Invasive Cardiol 2011;23:E291-2.

Spargias K, Milewski K, Debinski M, Buszman PP, Cokkinos DV, Pogge R, Buszman P. Drug delivery at the aortic valve tissues of healthy domestic pigs with a paclitaxel eluting valvuloplasty balloon. J Interv Cardiol 2009;22:291-8.

Wilczek K, Chodór P, Przybylski R, Krasoń M, Niklewski T, Nadziakiewicz P, Głowacki J, Kusa J, Goddyn D, Spargias K, Zembala M. First in Poland transcatheter, transfemoral aortic valve implantation in elderly symptomatic high-risk patient with aortic stenosis-novel Zabrze experience. Kardiol Pol 2009;67:219-23.

Kolettis TN, Spargias K, Stavridis GT. Combined transapical aortic valve implantation with coronary artery bypass grafting in a young patient with porcelain aorta. Hellenic J Cardiol 2009;50:79-82.

Trendafilova D , Jorgova J, Simeonov P. Acknowledgement to Dr K Spargias. First Transfemoral Aortic Valve Implantation In Bulgaria. The Internet Journal of Cardiology 2010;9:2.


  • Transcatheter (percutaneous) aortic valve replacement

  • Transcatheter (percutaneous) repair of mitral valve regurgitation with MitraClip

  • Transcatheter (percutaneous) closure of paravalvular leaks

  • Valvuloplasty of heart valves

  • Coronary angiography

  • Percutaneous coronary revascularization (angioplasty-stent)

  • Cardiac catheterization

  • Heart biopsy

  • Pericardiocentesis

  • Septal branches alcohol ablation

  • Pulmonary hypertension reactivity tests

AORTIC VALVE STENOSIS
The aortic valve is one of the 4 heart valves, and through this valve the blood is pumped from the heart to all over the human body. The normal aortic valve opening is 3-4 cm2.

The degenerative mechanism that causes aortic valve narrowing (stenosis) is dynamic and evolving. The main features of this process are gradual stiffening and thickening of the valve with calcium deposits that limit leaflet mobility and eventually narrow the valve. Approximately 5% of elderly population (>75 years) suffer from at least moderate aortic valve stenosis. The narrowing of the valve is considered significant when the opening is reduced to less than 1 cm2.
The most usual symptoms of aortic stenosis are shortness of breath, anginal pain and dizziness or even syncopal attacks. The average patient survival after symptoms onset is 3-5 years.

Drug therapies can relieve symptoms but they do not touch on the valve stenosis. The only definitive treatment is valve replacement. However, many patients are in advanced age and have much co-morbidity that render the surgical risk unacceptable. Therefore, surgical replacement is considered too risky and they are not referred for operation. The prognosis and the quality of the remaining life in these patients are poor.

Transcatheter valve replacement (TAVR) has been initially developed and successfully employed in these patients since 2007. Since 2011 TAVR is also successfully employed in patients who could undergo surgical replacement but are considered high-risk. With single-digit mortality figures and fast rehabilitation and return to daily activities the advantages of this method are obvious.



The transcutaneous valves SAPIEN XT (Edwards Lifesciences) και CoreValve (Medtronic), Portico (ST Jude), Lotus (Boston Scientific)

X-ray images from Transfemoral implantation of SAPIEN XT, Edwards Lifesciences and CoreValve, Medtronic, valves

THE TRIALS
The results of the randomized clinical trial PARTNER-B were reported in 2010, and for the first time a transcutaneous method of treating aortic stenosis was found to change the natural history of the disease and prolong survival. Elderly patients with comorbidities that by general consensus would have been treated conservatively were randomly subjected to TAVR and they experienced impressive improvements in their symptoms, decrease in the need for hospitalization, and most importantly a 54% mortality reduction within the first year after the procedure. Hence, the method was established as the standard of care in this patient population.

The acceptance of TAVR since 2007 (when it received the approval of the EU authorities) has been wide and the number of the procedures performed has been increasing with a geometrical pattern (60-90% yearly increase). More than 90000 implantations have been performed to date (July 2013) (approximately 600 in Greece). The volume of TAVRs performed in Europe in 2012 was 50% of the respective surgical aortic valve replacement volume (in most west European countries the implantation rate was approximately 100 TAVRs per million of population).

The results of another trial, the PARTNER-A, were reported in March 2011. The importance of this study is that it randomized patients at “high” surgical risk (Logistic EuroSCORE ≥15%) but not prohibitive to be accepted for surgical treatment, to TAVR or standard surgical replacement. The 30-day mortality for TAVR patients was 50% less than that in the surgicaly treated patients (3.4% vs. 6.7%), ascertaining that the two methods are at least equivalent in this patient population. The 1-year survival was by 2.6% lower in TAVR, and especially for transfemoral TAVR the 30-day survival was significantly better as compared to the surgical arm.

The PARTNER-A results have provided the first comparative assessment of TAVR versus the standard surgical replacement and it demonstrated that even moderately-high risk patients benefit from TAVR at least to the same extent they benefit from surgery. In addition, they gain a faster recovery with this minimally invasive treatment.

The third generation transcatheter valves have been already in use since 2011 (SAPIEN XT with Novaflex+, Edwards; CoreValve with Accutrak, Medtronic) and they have undoubtedly made the procedure more patient- and doctor-friendly. More technology advances are expected and recently three other transcutaneous valve types has been approved for clinical use in Europe.

With regards to clinical outcomes, the most recent European registries have shown that the 30-day transfemoral TAVR mortality is 3-5% and for the transapical/transaortic TAVR is 6-10%.

The THV department performs implantations of both valve types currently available (SAPIEN 3, Edwards Lifesciences; CoreValve Evolut R, Medtronic; Portico, St Jude; JENA Valve, Boston Scientific) and from all possible implantation routes (transfemoral, transaortic, transapical, subclavian). Our experience exceeds 400 successful implantations.

THE PROCEDURE
Transfemoral implantation
The procedure is performed through the artery at the groin in a way similar to coronary angiography. We follow extremely strict infection control rules at our Hybrid OR. The procedure is done without general anesthesia, only light sedation is used. The duration of the procedure is less than an hour, but the entire process takes approximately 1.5 hours.
The entry point at the groin artery is sealed with a suture that is inserted with a special closure device without surgical cut. The patient remains in the ICU for one night and then in a common ward usually for 2 nights before discharge.
The majority of patients (80%) are suitable for transfemoral implantation (from the groin). Transfemoral implantation is always preferred because it is the less invasive method.

Transaortic and transapical implantation
The procedure is performed under general anesthesia and the valve is implanted through the aorta (transaortic) with an upper right side small thoracotomy or directly through the heart muscle via a small left thoracotomy between the chest ribs. The duration of the procedure is less than an hour, but the entire process takes approximately 2 hours. The incision between the ribs is approximately 5cm and it is closed with sutures after the valve implantation.

The patient remains in the ICU for one night and then in a common ward for another 2-3 nights before discharge.
The transapical and transapical implantation is reserved only for those patients whose peripheral arteries (femoral and subclavian) are not suitable for valve insertion (less than 20% of patients). These patients also benefit from the main advantages of the method (no need for sternotomy and bypass).

The SAPIEN XT valve can be implanted both transaortically and transapically, while CoreValve can be implanted transaortically.

X-ray images of Transapical valve implantation

PATIENT SCREENING
The patient suitability for TAVR and the decision of the valve type and the route of implantation is made after screening, usually during a 24 hour hospitalization. During this time we perform coronary and other angiographies, CT scans, heart ultrasound, blood and other tests that are deemed necessary for the individual patient. The patient is also assessed by the members of the THV team (Anesthesiologist, CT and Vessel Surgeon). It is during this hospitalization that it is possible to treat significant coronary artery disease with angioplasty and stenting, or perform palliative aortic valvuloplasty in unstable patients.

Mitral Valve Insufficiency (Regurgitation)
It is the most frequent valvular disease and it is estimated that approximately 8% of all humans older than 75 years suffer from at least moderate mitral valve disease. The leakage of this valve results in blood returning to the lungs instead of complete forwarding to the body. Advanced mitral insufficiency causes symptoms of heart failure such as fatigue, various degrees of shortness of breath (even pulmonary edema) and increases the risk of atrial fibrillation (heart rhythm irregularity) and stroke.

Mitral insufficiency is characterized as functional (usually due to coronary artery disease or dilated cardiomyopathy) or degenerative (usually due to fibroelastic dysplasia leading to valve prolapse and ruptured chordae).
Pharmaceutical treatment can alleviate symptoms or even slow the progress, at least at the initial stages of the disease. However, since the root is a mechanical problem, it cannot be corrected with pharmaceutical treatments alone.

Surgical treatment of functional mitral insufficiency is usually attempted only when surgery is required for another reason (such as bypass operation). The risk of such operation is usually high.

Surgical treatment of degenerative mitral insufficiency on the other hand, is the gold standard. Mitral valve repair instead of replacement is always desirable and in most cases it can be achieved successfully as a low risk operation.

MitraClip: Device for transcatheter correction of mitral insufficiency
The MitraClip device (Abbott Vascular) is based on the deployment of a clip in the mitral valve via a catheter inserted through the groin vein. This method mimics a surgical technique of treating mitral insufficiency (called the Alfieri technique) that transforms the single hole of the valve into a double-hole passage by suturing the edges of the two valve curtains. MitraClip achieves the same result by clipping the curtains but without open heart surgery.

The MitraClip method has been proved to significantly and sustainably reduce the valve leaking and to significantly improve patient symptoms and quality of life similarly to surgery, However, MitraClip achieves this with a lower risk, less invasive procedure and with faster recovery.

The MitraClip system has 3 parts:

  • The telescopic guiding catheter
  • The clip delivery system
  • The MitraClip

The procedure is performed without sternotomy and without extracorporeal circulation (bypass) since the clip is inserted via the groin vein under general anesthesia. The patient is mobilized the following day and returns to his normal activities within a few days.

MitraClip is the first transcatheter system for mitral valve repair received the CE mark since 2008. More than 7000 patients have undergone the MitraClip procedure to date (March 2012). This procedure was introduced in Greece in October 2011 by our THV department at Hygeia Hospital and implantations have been performed regularly since.

Potential MitraClip indications
MitraClip can significantly reduce or even eliminate valve insufficiency in the following cases:

  • Significant functional mitral valve insufficiency requiring treatment (in the absence of need for other heart surgery)
  • Degenerative mitral valve insufficiency due to prolapse of the middle cusps in high surgical risk patients

The anatomical criteria for MitraClip therapy suitability are assessed with transthoracic and transesophageal echocardiography.

The HYGEIA Hospital Transcatheter Heart Valve Department is an official global training center for the Evolut R valve by Medtronic, the Sapien 3 valve by Edwards and the Portico valve by Abbott, while its medical staff are trainers for the placement of valves produced by Edwards, Medtronic and Abbott, as well as the Mitraclip system.

Annual conferences are organized on the latest developments in transcatheter heart valve therapies.

The 6th Transcatheter Heart Valve Therapy Conference will take place at Hilton Hotel, Athens, on May 12-13, 2017. Find out more.

 

 

5th Conference of Transcatheter Heart Valve Therapies

4th Conference on Structural Heart Disease Trancatheter Therapy & Pre-conference Seminar for Resident & New Cardiologists

3rd Conference on Transcatheter Heart Valve Therapies

2nd Conference on Transcatheter Cardiac Valve

1st Conference on Percutaneous Treatment of Cardiac Valves

9, Eryrthrou Stavrou - Opposite Hygeia Hospital
Office 1 
1st Floor 

Τelephone
+30 210 686 7310-7311

Medical Team