CSI HIGHLIGHT OF THE YEAR award:
Valvar

Background/supporting information: The native leaflets trapped between the valve frame and Anchor Rings creates a seal against PVL. Additionally, this attachment allows for a low radial force implant designed for a very low need for pacemaker and the Anchor Rings will self-align the implant to the native commissure alignment for optimal hemodynamics designed to prevent HALT and promote long-term durability. The low frame height and cut-outs in the frame allow for the treatment of coronary arteries as low as 1 mm and easy access to coronary arteries post-implant. Because of these features, the J-Valve has also been utilized for Valve-in Valve successfully where other TAVR devices would be at very high risk for coronary occlusion.

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Background/supporting information: By combining catheter-based technologies that directly address the annulus, leaflets, and chordae tendinae of the mitral valve, these pioneers have successfully treated over 30 patients with advanced beating heart technologies and have shared their learnings with the cardiac surgery and cardiology communities of physicians across the globe.

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Background/supporting information: LuX-Valve`s innovative designs: Valve disc can attach on the autologous valve to prevent perivalvular leakage. Non-radical force anchor system includes two graspers and an interventricular anchorage.

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Background/supporting information: The Leaflex™ device is intended to address the unmet need for an effective, durable, non-implant-based treatment for patients with calcific aortic stenosis (AS). It may be used for the following indications:

1. As a destination therapy in patients where TAVR is less suitable, such as elderly and frail patients   and those with limited functional capacity or life expectancy; 

2. As a bridge procedure in patients who are scheduled to undergo TAVR, SAVR or non-cardiac surgery; 

3. For delaying valve implantation, and avoiding a later valve-in-valve procedure in younger patients; 

4. For facilitating TAVR and improving its results in patients with heavy aortic root calcification or bicuspid aortic valve morphology (better stent frame expansion leading to longer durability, reduced paravalvular leak (PVL) and low PM rates).

The Leaflex™ offers valve repair technology rather than prosthesis implantation, avoiding potential short- and long-term valve implantation related complications, such as prosthetic valve endocarditis, PVL, and structural valve deterioration. In addition, the Leaflex™ procedure has the ability to be repeated at a later stage if TAVR remains undesirable, eliminating the need for bioprosthesis implantation. Finally, the relative cost-effectiveness of this procedure is an important advantage compared to TAVR in the current cost constrained environment. 

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Background/supporting information: In detailed measurements of scatter radiation around the x-ray table (using a US DOE anthropomorphic phantom) we found that, without shielding, 69% of the scatter x-radiation dose received by personnel comes from below the tabletop.  Positions near the head of the table results in the largest x-ray doses to personnel.  The nurse who stands 1.5 meters from the table receives a higher radiation dose than the assistant next to the operator.

The EggNest system markedly reduced personnel radiation exposure around the x-ray table.  Compared to standard shielding in the PA projection, the EggNest reduced personnel dose by an average of 91%.  In the angulated projections, x-ray dose to personnel was reduced by 87-94% (compared to standard shielding).  The dose to the nurse 1.5 M from the table was reduced by 94%.  Total room scatter radiation (averaging all angiographic angles and positions around the table) was reduced by an average of 92%.

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Background/supporting information: Apart from the previously mentioned benefit regarding one-year combined death and stroke, the following important data regarding postoperative morbidity, quality of life and valve performance are important:

• The 30-day combined rate of death or stroke was lower after TAVI compared with surgical valve replacement (1.0% vs. 3.3%, p=0.01)
• The 30-day stroke rate was lower after TAVI compared with surgical valve replacement (0.6% vs. 2.4%, p=0.02)
• The one-year death or disabling stroke rate was lower after TAVI compared with surgical valve replacement (1.0% vs. 2.9%, HR 0.34 95% CI 0.12-0.97)
• The rate of 30-day post-procedural/postoperative atrial fibrillation was seven times higher in patients after surgical valve replacement compared to TAVI (5% vs. 40%, p<0.001)
• The re-hospitalization rate was lower in the TAVI group compared to the surgical group (one-year: 7.3% vs. 11.0%, 95% CI, 0.42-1.00)
• The length of index hospitalization was lower after TAVI compared with surgical valve replacement (median 3.0 days vs. 7.0 days, p<0.001)
• Patients achieved a better functional capacity faster after TAVI compared with surgical valve replacement (less patients at 30 days in NYHA functional class II, III or IV, higher increase in 6-minute walking distance at 30 days after TAVI)
• The effective orifice areas were similar comparing TAVI to surgical valve replacement (at one year 1.7 cm2 after TAVI vs. 1.8 cm2 after surgical valve replacement)
• There was no difference in the percentage of patients with greater than mild paravalvar regurgitation between TAVI and surgical valve replacement (0.6% vs. 0.5%)

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Background/supporting information: It is estimated that 165,000 low risk patients suffer from severe aortic stenosis per year in the U.S., Western Europe and Japan. If left untreated, it can cause heart failure in as little as two years. Currently, symptomatic low risk patients with stenotic aortic valves are required to undergo open heart surgery. TAVI is a less invasive alternative to open heart surgery. TAVI is not currently indicated for low risk patients. The Evolut Low Risk trial will be a key element in the assessment of indication expansion to this patient category.

Low Risk Trial

• Like many other randomized TAVI trials conducted to date, the Evolut Low Risk Trial used a non-inferiority analysis to compare TAVI to surgery. The intent of the trial’s primary endpoints was to show non-inferiority to SAVR in low risk patients.
• The Evolut TAVI system had lower mean aortic valve gradients (8.6 mm Hg vs. 11.2 mm Hg) and larger EOAs (effective orifice area) (2.3 for TAVI vs. 2.0 for SAVR) at 12 months. Along with meeting the primary endpoint, the results also achieved EOA and mean gradient (hemodynamic) superiority for TAVI at 12 months and KCCQ (return to quality of life) scores from baseline superiority for TAVI at 30 days.
• Rates of the prespecified 30 day safety composite of all-cause mortality, disabling stroke, life-threatening bleeding, major vascular complications or acute kidney injury were significantly lower for TAVI as compared to SAVR (5.3 percent for TAVI versus 10.7 percent for SAVR), as were the rates of the composite primary endpoint of all-cause mortality or disabling stroke at 30 days (0.8 percent for TAVI versus 2.6 percent for SAVR), although the pacemaker rate was greater in the TAVI treatment arm.

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