AVR with Sutureless Valves State of the Art

Transcription

1 AVR with Sutureless Valves State of the Art T. Fischlein Department of Cardiac Surgery, Cardiovascular Center Klinikum Nürnberg Paracelsus Medical University Nuremberg, Germany

2 Disclosures Consultant and Proctor for LivaNova Consultant and Proctor for BioStable

3 Features & Benefits Sutureless (Perceval) UNIQUE COLLAPSIBLE DESIGN Thanks to dedicated accessories, the valve diameter can be reduced prior to implantation, increasing visibility. PRECISE POSITIONING Three guiding sutures are used to position the valve in the aortic root. Thanks to this and to the enhanced visibility, precise positioning becomes easier and reproducible. TRULY UNIQUE SUTURELESS VALVE Self-expands in place (no need to knot sutures), reducing operation time and trauma.

4 Perceval advantages thanks to the Collapsibility feature The unique Perceval properties allow to: Reduce the trauma of the operation (smaller incisions, fast and easy positioning, no sutures, reduced ischemic time for the patient, reduced aortic root manipulation) Positioning the valve in a precise, safe, reproducible and controlled way Improving visualization and facilitate even MICS procedures, REDO cases, implantation in small annuli, calcified annuli, obese patients 4

5 Indications & Contraindications (Sutureless) Patients sensitive to cross clamp time Patients with Multiple Risk factors Diabetic patients Patients with low EF AVR + CABGs Old patients WHO CAN BENEFIT THE MOST FROM PERCEVAL? Technically Challenging procedures or at risk of PPM Re-Do Small annuli Calcified aortic roots Obese Patients Patients who need a less traumatic Procedure Patients who need a faster recovery

6 Sutureless Consensus paper key recommendations from an international panel Key recommendations regarding PATIENTS INDICATIONS: Sutureless = alternative to stented valves in patients requiring biological aortic valve replacement Sutureless can be more beneficial in challenging cases redo cases delicate aortic wall conditions as calcified root, prior implantation of aortic homograft or stentless Sutureless valves are the first choice in case of concomitant procedures (including multiple valves) or small annulus to reduce XCT

7 Key Recommendations Sutureless when? Use of sutureless and rapid deployment valves together with minimally invasive approaches in patients requiring biological valve replacement and not serving as candidates for TAVI Use of sutureless and rapid deployment valves are recommend in order to reduce extracorporeal circulation and aortic cross-clamp time Oversizing with sutureless valves is not beneficial and can have negative impact Use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement Take respect to necessary, brief learning curves for both sutureless and minimally invasive programs 7

8 Indications & Contraindications WHAT ARE THE MAIN CONTRAINDICATIONS - Sutureless Aneurysmal dilation or dissection of the ascending aortic wall Congenital bicuspid aortic valve (Sievers 0) Anatomical characteristics indicating an enlargement of aortic root (e.g. if the ratio of the sinotubular junction Ø and the annulus Ø is larger than 1.3) Endocarditis?

9 Reported PM Implantation Valve Traditional sutured Pacemaker rate (Early) 3.0%-11.8% Mean:7.0%, Author Matthews et al 2011[2] The incidence of PPM implantation following traditional AVR reported in literature can vary from 3.0% to 11.8% (mean 7.0%) [2]. Traditional sutured (Partner II intermediate risk population) 6.9% Leon et al [3] All the risk factors shown in the previous slide may contribute to the variability among centers [3]. Perceval (cavalier trial) 11.8% (Overall) Data on file Perceval (cavalier trial) 9.6% (as a result of AV block III) Fischlein et al 2015 [4] Sutureless, Rapid deployment valves have shown, on average, a slightly higher PM rate compared to traditional valves. Perceval Intuity (Transform) 6 % (as a result of AV block III in patients with no preop cond disorders) 14 % (overall) 11.9% (isolated only) Shrestha et al [5] Barnhart et al 2016 [6] 9

10 Indications (Sutureless) Patients undergoing combined procedures with CABG Published Experience 243 patients with combined procedures Shortening the aortic clamp time and ECC time may help to reduce mortality and morbidity during concomitant procedures Perceval Sutureless proved to be an excellent solution for patients requiring concomitant procedures

11 Indications Patients with small annuli Published Experience

12 Indications Patients with calcified aortic roots Published Experience Elderly Patients: - Lower operative mortality - Lower incidence of sepsis - Lower wound complications - Shorter hospital stay - Faster rehabilitation and discharge

13 Minimal invasive AVR - Right anterior Minithoracotomy (RAT)

14 Redo-OP: after CABG e.g. for AVR Re-op Patients: J Thorac Dis Nov;5(Suppl 6):S669-S672 - Less bleeding - Fewer transfusions Less trauma

15 Perceval is retrievable Stent features and properties PERCEVAL Edwards Intuity Elite Valve retrieval Perceval can be easily retrieved. Perceval retrieval has shown to be feasible and safe for the patient without damaging the aortic root. In case of malpositioning Intuity can be difficult to remove. 15

16 Complications, Management - Repositioning X Movement in a Redo AVR Case

17 Sutureless (Perceval) is the MICS enabler Mini-sternotomy Right Anterior Thoracotomy

18 - Full Sternotomy (Standard) - Mini Sternotomy (Upper Sternotomy), 3 rd or 4 th ICS right (J-Sternotomy) or left or transverse - Right anterior Mini Thoracotomy (RAT), 2 nd or 3 rd ICS Mini Sternotomy RAT

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20 MIS with conventional aortic valves PROs Reduced Surgical Trauma Decreased Blood Loss Lower Mortality Lower Analgesic Lower ICU Stay Reduced Intubation Time Faster Recovery Less Pain Better Cosmetic Results CONs Technically More Complex Higher Learning Curve Higher X-Clamp Time Higher ECC Time

21 Indications & Contraindications: Published Experience

22 The Sutureless Solution The concept of a sutureless prosthesis has been developed with the aim of: simplifying the surgical technique reducing the implantation time Resektion der AK Taschen, Entkalkung facilitates MICS procedures enables concomitant procedures providing a curative solution, removing the native diseased aortic valve (in contrast to TAVI) Improving clinical outcome Resektion der AK Taschen, Entkalkung AKE

23 Undisputed reduction of XCT in all comparative studies Sutureless (Perceval) vs traditional valves Average XCT saving of 40% (=29 minutes, min 14 max 49) Comparative studies Perceval vs conventional AVR D Onofrio 2013 Dalen 2015 Gilmanov 2014 approach Perceval approach: Full sternotomy, hemisternotomy, RAT vs traditional valve in full sternotomy Perceval in MICS vs Perimount in full sternotomy Isolated/ RAT XCT Perceval XCT trad valves P value Time saving < % < % < % Muneretto 2015 Isolated/all approaches = % Santarpino 2013 Isolated/MICS < % Cross Clamp time savings (%) Shrestha 2013 Perceval in MICS 72% vs conventional in MICS 4.3% < % 23

24 Perceval and Stented valves: a propensity-matched score analysis Traditional Sutured Perceval ICU stay (Days) 2.8 Transfusion (Blood units) 2.5 Ventilation (Hours) Source: Better Short-Term Outcome by Using Sutureless Valves: A Propensity-Matched Score Analysis Pollari et al., Ann Thorac. Surgery 2014 Aug;98 (2): 611-6

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26 Perceval Sutureless Valve Haemodynamic Performance Perceval shows excellent hemodynamic performance with stable gradients over time, which has been reported in various publications The results of the largest cohort can be found in the paper European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients Shrestha et al. Eur J Cardiothorac Surg Mar 6. 26

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28 Perceval vs. TAVI More Cost Effective in Gray Zone Patients The costs associated to the 2 procedures are similar when the cost of the device was excluded (p = 0.217). When included, the sutureless approach resulted a cost saving ( 22,451 vs 33,877, p <0.001). In conclusion, the patients in the gray zone record a satisfying clinical outcome after sutureless surgery and TAVI. Patients in the sutureless group endure more hospital complications, but TAVI entails a higher follow-up mortality. On the costs aspects, TAVI technologies are more expensive, and it reflects on higher overall hospital costs. Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis Santarpino et al The American Journal of Cardiology, 2015

29 Perceval vs TAVI Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis Santarpino et al The American Journal of Cardiology, 2015

30 Sutureless vs. TAVI Sutureless vs TAVI with para-valvular insufficiency Sutureless vs TAVI without para-valvular insufficiency PVL after TAVI Months Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis Santarpino et al; The American Journal of Cardiology, 2015

31 Perceval vs TAVR vs Stented valves a propensity-matched score analysis Propensity matched study: 204 vs 204 vs 204 patients Outcomes: Perceval showed lower rates than TAVR and savr of postop complications at 30 days Perceval showed higher survival rates and freedom from MACCE at 24 months

32 Summary Sutureless allows: Time reduction shorter cross-clamp, CPB and operation time Better outcome shorter intubation time, ICU and hospital stay; less need of transfusions; even in combination with minimal invasive access surgery Cost reduction proven throughout different experiences As a consequence of this positive economic profile and the relevant increased use of the sutureless technology, some insurances have granted additional and more favorable reimbursement levels to sutureless prostheses compared to traditional valves Are we still going to implant traditional tissue valves in the future?

33 PERceval Sutureless Implant Vs STandard - Aortic Valve Replacement First Randomized trial to compare Perceval and standard AVR CT-Scan for surgical planning Low to medium risk patients High number of Mini-sternotomy approach Results will have an impact not only on Perceval but also on standard AVR and could influence future guidelines First large Randomized Trial in Valve Surgery in the last 30 years 33

34 Advantages of Sutureless Prostheses AVR with Sutureless Prostheses Is safe, fast and easy, requiring a short learning curve Shows excellent outcome and patient satisfaction Has the potential to shorten aortic XCT significantly Perceval: Results show advantages for: Small aortic roots Calcified roots Redo and Combined Procedures (AVR+ CABG, septal myectomy, Afib)

35 Conclusions AVR with Sutureless Valves Sutureless aortic valve replacement: A valuable option to reduce trauma of operation in everyday surgery and facilitates fast recovery Is a major step forward for MIC - AVR A cost saving solution, which helps reducing hospital resource consumption (reduced ICU and Hospital stay) Closes the gap between conventional and catheter based (TAVI) aortic valve implantation Sutureless technology = future for AVR

36 Thank you!

37 Cardiac Surgery vs. Cardiology Minimal invasive WHY? David vs. Goliath Small Society AVR Conventional with CPB, Big sternotomy Offer patients: Minimal invasive new technologies; Have to change attitude, Improve results and Increase our power Big Society AVR TAVI Real minimal invasive technique, Beating heart, Offer patients: Small puncture in the groin or full sternotomy Gate Keeper

38 VIV in Perceval Sutureless Valve The ViV procedure with Perceval is feasible and some published experiences report successful results with SapienXT, CoreValve and Evolut-R: 1. Sapien 3 (23mm) transfemorally deployed in a Perceval size S. Durand et al. Canadian Journal of Cardiology, Sapien XT (23 mm) transfemorally deployed in a Perceval size M. Di Eusanio et al.- Ann Cardiothorac Surg CoreValve transfemorally deployed in a Perceval. Bullesfeld et al. Presented at LondonPCR 2014 as live case 4. Sapien XT (23mm) transapically deployed in a. Fujitaa B. et al.- Interactive CardioVascular and Thoracic Surgery Corevalve and Evolute-R deployed in Perceval. Amabile et al. - The Journal of Thoracic and Cardiovascular Surgery 2016 Perceval Hemodynamics OUS IM A 38

39 Aortic Valve Replacement Sutureless (Perveval) Cardiac Surgery - Klinikum Nürnberg