Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina PectorisA Prospective, Open-Label, Multicenter, Safety Feasibility First-in-Man Study
Shmuel Banai, MD*,1,*,
Shmuel Ben Muvhar ,1,
Keyur H. Parikh, MD ,
Aharon Medina, MD ,
Horst Sievert, MD||,
Ashok Seth, MD¶,
Jonathan Tsehori, MD*,
Yoav Paz, MD*,
Ami Sheinfeld, MD# and
Gad Keren, MD*,1
* Cardiology Department, Tel Aviv Medical Center, Tel Aviv, Israel
Neovasc Medical, Inc., Or Yehuda, Israel
The Heart Care Clinic/SAL Hospital, Ahmedabad, India
Bikur Cholim Hospital, Jerusalem, Israel
|| Cardio Vascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany
¶ Max Devki Devi Heart and Vascular Institute, New Delhi, India
# Sheba Medical Center, Ramat Gan, Israel.
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Figure 2 Implantation of the Coronary Sinus Reducer Stent in Human Coronary Sinus
(A) Contrast-filled inflated balloon at the time of implantation of the Reducer stent in human coronary sinus. (B) Retrograde angiography of the coronary sinus after implantation of the Reducer.
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Figure 3 Cardiac Computed Tomographic Angiography of Human Hearts After Implantation of the Coronary Sinus Reducer Stent
(A) Three-dimensional reconstruction of the posterior aspect of the heart. The Reducer stent implanted at the proximal segment of the coronary sinus is clearly seen. (B, C) Longitudinal section of the coronary sinus. The proximal and distal diameters of the Reducer perfectly match the funnel-shaped coronary sinus.
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Figure 4 Angina Score (CCS) Before and 3 and 6 Months After Implantation of the Reducer
(A) Individual patients’ angina scores are presented at baseline and at 3 and 6 months after implantation. The Canadian Cardiovascular Society (CCS) class improved in 12 of the 14 patients 6 months after implantation and remained constant for 2 patients (p < 0.0001, n = 14). (B) The average angina score for the group, before implantation of the Reducer and 3 and 6 months later (n = 14).
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Figure 5 Exercise-Induced ST-Segment Depression Before and 6 Months After Implantation
Transient ST-segment depression was present during the baseline stress test in 9 patients. At 6-month follow-up, ST-segment depression was lower in 6 patients and was no longer present in 2 of the 6. For ST-segment depression, the average for the 9 patients was 2.00 mm at baseline and 1.22 mm at follow-up (p = 0.047).
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Figure 6 Stress Dobutamine Echocardiography Results at Baseline and 6 Months After Reducer Implantation
The score of all 18 segments of stress dobutamine echocardiography images were summed and compared at baseline (0 months) and at 6 months after Reducer implantation. The individual patients’ data are presented. For the group (n = 13), the mean score was lower at 6 months (average at baseline 25.08, average at 6 months 21.08, difference = 4.00; p = 0.004).
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