Archived Comments for:
A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial
The coronary sinus reducer in patients with refractory angina pectoris
Yoav Paz, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Israel
14 January 2015
Jolic Ur EM et al. erroneously compare the Neovasc coronary sinus reducer (CSR) to the Beck procedure, which has almost nothing in common with the Neovasc CSR. Actually this statement can be concluded by reading references 6-10 in Jolic Ur EM et al. study protocol.[1] In the 1940s, Dr Claude Beck described two types of coronary sinus (CS) interventions.[2-4] The Beck I procedure consisted of 4 components: 1) external surgical narrowing of the CS; 2) abrading both the epicardium and inner pericardium (some kind of neurectomy procedure that was used for the treatment of refractory angina pectoris in those days); 3) spilling of powdered asbestos and 5% aqueous trichloracetic acid on the epicardium; 4) placing mediastinal fat over the treated epicardium. The Beck II procedure consisted of 2 components in 2 separate sessions: 1) vascular graft implantation between the descending aorta and the CS, and 2) operative external constriction of the CS ostium 2-3 weeks later. Both procedures needed thoracotomy and have very little in common with the Neovasc CSR.
The main idea behind the Neovasc CSR was developed by Dr. Amihay Shinfeld and Dr. Yoav Paz that initiated an unusual, novel approach in the mid-1990s to support the ischemic myocardium.[5-12] Their suggestion was to limit the coronary blood outflow in cases where the coronary blood input is impaired and can't be repaired, in other words to rebuild retrograde coronary pressure that would be attenuated by the atherosclerotic disease by catheterization of the coronary veins instead of the atherosclerotic coronary arteries, and to reduce the CS diameter instead of expanding the narrowed coronary artery, and thus they called their approach ``the upside-down" strategy.
In a preliminary non-ischemic pig model, Dr. Shinfeld and Dr. Paz succeeded in increasing the mean CS pressure from 7.0 to 24.6 mmHg (P =0.011) after CSR deployment. Macroscopic and histologic investigations of the treated hearts in this model revealed that 8 to 12 weeks of coronary sinus narrowing produced macroscopic epicardial and intra-myocardial new blood vessels -neovascularization. Histopathlogic analysis described these findings as follows: significant proliferation of small to medium-sized vessels, containing smooth muscle representing coronary collaterals. This was evident in almost all specimens, representing various myocardial anatomical areas, including specimens from the anterior and mid-posterior wall. The most significant proliferation was evident in the peri-coronary sinus specimens, including both anterior and posterior specimens. According to these unpredicted neovascularization findings the developers created the name "Neovasc" for this novel CSR device.
References:
1. Jolic Ur EM, Banai S, Henry TD et al. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials 2013;14:46.
2. Edmunds LH. Cardiac Surgery in the Adults. In: Techniques of Myocardial Revascularization. New York: McGraw-Hill, 1997:482.
3. Beck C. The coronary operation. Am Heart 1941;J 22:539.
4. Beck C, Stanton E, Batinchok W, et al. Revascularization of heart by graft of systemic artery. JAMA 1948;137:436.
5. Paz Y. A new cardiopulmonary resuscitation method. Am J Emerg Med 2008;26(3):374-5.
6. Mohl W, Mina S, Milansinovic D, et al. Coronary sinus reducer stent. J Thorac Cardiovasc Surg 2008;136(5):1390.
7. Paz Y, Shinfeld A. Mild increase in coronary sinus pressure with coronary sinus reducer stent for treatment of refractory angina. Nat Clin Pract Cardiovascular Med 2009;6(3):E3.
8. Paz Y, Shinfeld A. More on treatment for refractory angina. Minn Med 2009;92(9):6.
9. Paz Y, Shinfeld A. Coronary sinus reducer stent. Heart 2010;96:312-3.
10. Paz Y, Shinfeld A. The coronary sinus reducer stent for the treatment of chronic refractory angina pectoris. Rev Esp Acrdiol 2011;64(7):628.
11. Paz Y, Shinfeld A. Coronary sinus intervention for the treatment of refractory angina pectoris. Vasc Health Risk Manag 2011;7:135-6.
12. Paz Y, Shinfeld A. The Coronary Sinus Reducer Stent for the Treatment of Chronic Angina Pectoris. Pain Pract 2011;11(6):582.
Competing interests
Dr. Yoav Paz and Dr. Amihay Shinfeld are the inventors of the Neovasc Coronary Sinus Reducer Stent. Currently none have any commercial or other association with the company whose product is the subject of the comment or with a company that manufactures comparable products.
Trials
The coronary sinus reducer in patients with refractory angina pectoris
14 January 2015
Jolic Ur EM et al. erroneously compare the Neovasc coronary sinus reducer (CSR) to the Beck procedure, which has almost nothing in common with the Neovasc CSR. Actually this statement can be concluded by reading references 6-10 in Jolic Ur EM et al. study protocol.[1] In the 1940s, Dr Claude Beck described two types of coronary sinus (CS) interventions.[2-4] The Beck I procedure consisted of 4 components: 1) external surgical narrowing of the CS; 2) abrading both the epicardium and inner pericardium (some kind of neurectomy procedure that was used for the treatment of refractory angina pectoris in those days); 3) spilling of powdered asbestos and 5% aqueous trichloracetic acid on the epicardium; 4) placing mediastinal fat over the treated epicardium. The Beck II procedure consisted of 2 components in 2 separate sessions: 1) vascular graft implantation between the descending aorta and the CS, and 2) operative external constriction of the CS ostium 2-3 weeks later. Both procedures needed thoracotomy and have very little in common with the Neovasc CSR.
The main idea behind the Neovasc CSR was developed by Dr. Amihay Shinfeld and Dr. Yoav Paz that initiated an unusual, novel approach in the mid-1990s to support the ischemic myocardium.[5-12] Their suggestion was to limit the coronary blood outflow in cases where the coronary blood input is impaired and can't be repaired, in other words to rebuild retrograde coronary pressure that would be attenuated by the atherosclerotic disease by catheterization of the coronary veins instead of the atherosclerotic coronary arteries, and to reduce the CS diameter instead of expanding the narrowed coronary artery, and thus they called their approach ``the upside-down" strategy.
In a preliminary non-ischemic pig model, Dr. Shinfeld and Dr. Paz succeeded in increasing the mean CS pressure from 7.0 to 24.6 mmHg (P =0.011) after CSR deployment. Macroscopic and histologic investigations of the treated hearts in this model revealed that 8 to 12 weeks of coronary sinus narrowing produced macroscopic epicardial and intra-myocardial new blood vessels -neovascularization. Histopathlogic analysis described these findings as follows: significant proliferation of small to medium-sized vessels, containing smooth muscle representing coronary collaterals. This was evident in almost all specimens, representing various myocardial anatomical areas, including specimens from the anterior and mid-posterior wall. The most significant proliferation was evident in the peri-coronary sinus specimens, including both anterior and posterior specimens. According to these unpredicted neovascularization findings the developers created the name "Neovasc" for this novel CSR device.
References:
1. Jolic Ur EM, Banai S, Henry TD et al. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials 2013;14:46.
2. Edmunds LH. Cardiac Surgery in the Adults. In: Techniques of Myocardial Revascularization. New York: McGraw-Hill, 1997:482.
3. Beck C. The coronary operation. Am Heart 1941;J 22:539.
4. Beck C, Stanton E, Batinchok W, et al. Revascularization of heart by graft of systemic artery. JAMA 1948;137:436.
5. Paz Y. A new cardiopulmonary resuscitation method. Am J Emerg Med 2008;26(3):374-5.
6. Mohl W, Mina S, Milansinovic D, et al. Coronary sinus reducer stent. J Thorac Cardiovasc Surg 2008;136(5):1390.
7. Paz Y, Shinfeld A. Mild increase in coronary sinus pressure with coronary sinus reducer stent for treatment of refractory angina. Nat Clin Pract Cardiovascular Med 2009;6(3):E3.
8. Paz Y, Shinfeld A. More on treatment for refractory angina. Minn Med 2009;92(9):6.
9. Paz Y, Shinfeld A. Coronary sinus reducer stent. Heart 2010;96:312-3.
10. Paz Y, Shinfeld A. The coronary sinus reducer stent for the treatment of chronic refractory angina pectoris. Rev Esp Acrdiol 2011;64(7):628.
11. Paz Y, Shinfeld A. Coronary sinus intervention for the treatment of refractory angina pectoris. Vasc Health Risk Manag 2011;7:135-6.
12. Paz Y, Shinfeld A. The Coronary Sinus Reducer Stent for the Treatment of Chronic Angina Pectoris. Pain Pract 2011;11(6):582.
Competing interests
Dr. Yoav Paz and Dr. Amihay Shinfeld are the inventors of the Neovasc Coronary Sinus Reducer Stent. Currently none have any commercial or other association with the company whose product is the subject of the comment or with a company that manufactures comparable products.