© 2014 Wiley Periodicals, Inc.
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An Alternative for Surgical Management of Calcific Aortic Valve Stenosis: Sutureless Valve Implants Hector I. Michelena, M.D.,* Robert E. Michler, M.D.,y Maurice Enriquez-Sarano, M.D.,* Hartzell V. Schaff, M.D.,z and Rakesh M. Suri, M.D., D.Phil.z *Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota; yDepartment of Cardiovascular & Thoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York; and zDivision of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota ABSTRACT Patients who are candidates for surgical valve replacement (AVR) may benefit from diminished length of cardiopulmonary bypass time. Sutureless valve technology for AVR may facilitate the performance of the operation through smaller incisions, and more expeditiously due to the ability to anchor traditional bovine pericardial prostheses without the need for sutures. We report the first successful US implants of the Sorin PERCEVAL valve as part of the FDA IDE trial. doi: 10.1111/jocs.12333 (J Card Surg 2014;29:490–493) Recent innovations in aortic valve prosthesis design, minimally invasive surgical techniques, and the advent of transcatheter aortic valve replacement (TAVR) have provided new therapeutic options for patients with severe calcific aortic valve stenosis (AS). There is concern whether debris embolization and stroke risks are elevated following TAVR.1 It is thus uncertain whether TAVR will be an equally acceptable option for lower-risk patients who have excellent outcomes following traditional AVR. In addition, the incidence of post-TAVR perivalvular leaks (PVLs) is higher than conventional AVR and associated with increased mortality.2 Patients who are candidates for conventional surgical AVR may potentially benefit from shortened cardiopulmonary-bypass time. Sutureless valve technology for surgical AVR may facilitate the operation through smaller incisions, in a more expeditious manner owing to the ability to anchor a pericardial prosthesis without the need for sutures. These potential benefits become more attractive if the incidence of postoperative PVL is minimal. We report the first eight implants of
Conflict of interest: R.M.S.: Principle Investigator Sorin PERCEVAL Trial, research support from Edwards, Sorin, and St. Jude, Site PI Edwards PARTNER II Trial, Clinical Screening Committee Abbott COAPT Trial, Steering Committee St. Jude, PORTICO Trial. Address for correspondence: Rakesh M. Suri, M.D., D.Phil., Division of Cardiovascular Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. Fax: 507-255-8674; e-mail: suri.rakesh@ mayo.edu
the PERCEVAL S sutureless valve (Sorin group, Arvada, CO, USA) in the United States at two centers (Mayo Clinic and Montefiore Medical Center/Albert Einstein College of Medicine) as part of the US Food and Drug Administration Investigational Device Exemption (FDA IDE) Trial.
METHODS The PERCEVAL S valve (Fig. 1, panel D) is a bovine pericardium bioprosthesis assembled on a self-expanding Nitinol stent, designed for sutureless implantation.3 The stent has two cylindrical ring elements (figure, panel D, a. and d.) and two sets of struts (figure, panel D, b.), and its ability to apply moderate radial force to the implant site allows firm anchoring, avoiding PVL. Video 1 demonstrates the surgical procedure: A limited sternotomy or minithoracotomy is followed by a small aortotomy with native aortic valve and calcific debris excision, and subsequent sizing of the annulus. The appropriately sized valve is then mounted and collapsed onto the holder (figure, panel E). Three temporary sutures are used to guide the valve into the annulus. These sutures are subsequently removed. Once the valve has been completely deployed, the inflow ring is balloon dilated at 4 atm for 30 seconds. Following verification of complete contact between the inflow ring and the annulus, with appropriate sinus strut position (figure, panel F), the aortotomy is closed. Postbypass transesophageal echocardiogram verifies
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Figure 1. Intraoperative transesophageal echocardiogram (A, B, C, G, H, I) and PERCEVAL S valve (D) surgical implantation (E, F). (A) Prebypass long-axis view in early systole shows annular measurement; 20 to 21 mm. (B) Prebypass diastolic long-axis view with sinuses (31 mm) and STJ (25 mm) measurements. (C) Prebypass diastolic long-axis view with STJ height (25 mm) measured from annulus to STJ. (D) PERCEVAL S sutureless valve: a, outflow ring for STJ; b, sinusoidal strut for anchoring to Valsalva sinuses (short arrow) and straight commissural strut to support the valve (long arrow); c, bovine valve cusps; d, inflow ring to fit aortic annulus. (E) Collapsed PERCEVAL S valve mounted on holder. Note that cusps are not crimped and are freely mobile. Inflow ring is below and outflow ring is above. (F) Deployed PERCEVAL S valve as viewed from the supero-anterior position. The expanded valve is seen in place with the sinusoidal strut (arrow) conforming to the contour of the sinus of Valsalva. (G) Postbypass long-axis view shows a wellseated valve with wide cusp systolic excursion. Anterior and posterior aspects of the outflow ring at STJ are shown (arrows). See Video 2. (H) Postbypass short-axis view shows wide systolic excursion of cusps. (I) Postbypass diastolic short-axis color-flow frame shows no perivalvular regurgitation and normal coronary diastolic flow (blue). See Video 3. STJ, sinotubular junction; LA, left atrium; LV, left ventricle; Ao, aorta; LM, left main coronary artery; RCA, right coronary artery.
appropriate inflow and outflow ring seating and full systolic cusp excursion, and color flow Doppler is used to rule out the presence of PVL under physiologic conditions (figure, panels G, H, and I, Videos 2 and 3). The Institutional Review Board at participating institutions approved the trial. The PERCEVAL FDA IDE trial is a prospective, nonrandomized, multicenter US clinical trial designed to evaluate the safety and survival rates for the sutureless valve as compared to appropriate historical controls (http://clinicaltrials.gov/ct2/show/NCT01368666). Eligible patients are adults with severe AS, annular size between 19 and 25 mm, and sinotubular junction-to-
annulus ratio
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An Alternative for Surgical Management of Calcific Aortic Valve Stenosis: Sutureless Valve Implants Hector I. Michelena, M.D.,* Robert E. Michler, M.D.,y Maurice Enriquez-Sarano, M.D.,* Hartzell V. Schaff, M.D.,z and Rakesh M. Suri, M.D., D.Phil.z *Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota; yDepartment of Cardiovascular & Thoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York; and zDivision of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota ABSTRACT Patients who are candidates for surgical valve replacement (AVR) may benefit from diminished length of cardiopulmonary bypass time. Sutureless valve technology for AVR may facilitate the performance of the operation through smaller incisions, and more expeditiously due to the ability to anchor traditional bovine pericardial prostheses without the need for sutures. We report the first successful US implants of the Sorin PERCEVAL valve as part of the FDA IDE trial. doi: 10.1111/jocs.12333 (J Card Surg 2014;29:490–493) Recent innovations in aortic valve prosthesis design, minimally invasive surgical techniques, and the advent of transcatheter aortic valve replacement (TAVR) have provided new therapeutic options for patients with severe calcific aortic valve stenosis (AS). There is concern whether debris embolization and stroke risks are elevated following TAVR.1 It is thus uncertain whether TAVR will be an equally acceptable option for lower-risk patients who have excellent outcomes following traditional AVR. In addition, the incidence of post-TAVR perivalvular leaks (PVLs) is higher than conventional AVR and associated with increased mortality.2 Patients who are candidates for conventional surgical AVR may potentially benefit from shortened cardiopulmonary-bypass time. Sutureless valve technology for surgical AVR may facilitate the operation through smaller incisions, in a more expeditious manner owing to the ability to anchor a pericardial prosthesis without the need for sutures. These potential benefits become more attractive if the incidence of postoperative PVL is minimal. We report the first eight implants of
Conflict of interest: R.M.S.: Principle Investigator Sorin PERCEVAL Trial, research support from Edwards, Sorin, and St. Jude, Site PI Edwards PARTNER II Trial, Clinical Screening Committee Abbott COAPT Trial, Steering Committee St. Jude, PORTICO Trial. Address for correspondence: Rakesh M. Suri, M.D., D.Phil., Division of Cardiovascular Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. Fax: 507-255-8674; e-mail: suri.rakesh@ mayo.edu
the PERCEVAL S sutureless valve (Sorin group, Arvada, CO, USA) in the United States at two centers (Mayo Clinic and Montefiore Medical Center/Albert Einstein College of Medicine) as part of the US Food and Drug Administration Investigational Device Exemption (FDA IDE) Trial.
METHODS The PERCEVAL S valve (Fig. 1, panel D) is a bovine pericardium bioprosthesis assembled on a self-expanding Nitinol stent, designed for sutureless implantation.3 The stent has two cylindrical ring elements (figure, panel D, a. and d.) and two sets of struts (figure, panel D, b.), and its ability to apply moderate radial force to the implant site allows firm anchoring, avoiding PVL. Video 1 demonstrates the surgical procedure: A limited sternotomy or minithoracotomy is followed by a small aortotomy with native aortic valve and calcific debris excision, and subsequent sizing of the annulus. The appropriately sized valve is then mounted and collapsed onto the holder (figure, panel E). Three temporary sutures are used to guide the valve into the annulus. These sutures are subsequently removed. Once the valve has been completely deployed, the inflow ring is balloon dilated at 4 atm for 30 seconds. Following verification of complete contact between the inflow ring and the annulus, with appropriate sinus strut position (figure, panel F), the aortotomy is closed. Postbypass transesophageal echocardiogram verifies
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Figure 1. Intraoperative transesophageal echocardiogram (A, B, C, G, H, I) and PERCEVAL S valve (D) surgical implantation (E, F). (A) Prebypass long-axis view in early systole shows annular measurement; 20 to 21 mm. (B) Prebypass diastolic long-axis view with sinuses (31 mm) and STJ (25 mm) measurements. (C) Prebypass diastolic long-axis view with STJ height (25 mm) measured from annulus to STJ. (D) PERCEVAL S sutureless valve: a, outflow ring for STJ; b, sinusoidal strut for anchoring to Valsalva sinuses (short arrow) and straight commissural strut to support the valve (long arrow); c, bovine valve cusps; d, inflow ring to fit aortic annulus. (E) Collapsed PERCEVAL S valve mounted on holder. Note that cusps are not crimped and are freely mobile. Inflow ring is below and outflow ring is above. (F) Deployed PERCEVAL S valve as viewed from the supero-anterior position. The expanded valve is seen in place with the sinusoidal strut (arrow) conforming to the contour of the sinus of Valsalva. (G) Postbypass long-axis view shows a wellseated valve with wide cusp systolic excursion. Anterior and posterior aspects of the outflow ring at STJ are shown (arrows). See Video 2. (H) Postbypass short-axis view shows wide systolic excursion of cusps. (I) Postbypass diastolic short-axis color-flow frame shows no perivalvular regurgitation and normal coronary diastolic flow (blue). See Video 3. STJ, sinotubular junction; LA, left atrium; LV, left ventricle; Ao, aorta; LM, left main coronary artery; RCA, right coronary artery.
appropriate inflow and outflow ring seating and full systolic cusp excursion, and color flow Doppler is used to rule out the presence of PVL under physiologic conditions (figure, panels G, H, and I, Videos 2 and 3). The Institutional Review Board at participating institutions approved the trial. The PERCEVAL FDA IDE trial is a prospective, nonrandomized, multicenter US clinical trial designed to evaluate the safety and survival rates for the sutureless valve as compared to appropriate historical controls (http://clinicaltrials.gov/ct2/show/NCT01368666). Eligible patients are adults with severe AS, annular size between 19 and 25 mm, and sinotubular junction-to-
annulus ratio
