SURGICAL TECHNIQUE___________________________________________________________

An Alternative for SurgicalManagement of Calcific Aortic ValveStenosis: Sutureless Valve ImplantsHector I. Michelena, M.D.,* Robert E. Michler, M.D.,yMaurice Enriquez-Sarano, M.D.,* Hartzell V. Schaff, M.D.,z andRakesh 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 diminishedlength of cardiopulmonary bypass time. Sutureless valve technology for AVRmay facilitate the performanceof the operation through smaller incisions, and more expeditiously due to the ability to anchor traditionalbovine pericardial prostheses without the need for sutures. We report the first successful US implants of theSorin 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 adventof transcatheter aortic valve replacement (TAVR) haveprovided new therapeutic options for patients withsevere calcific aortic valve stenosis (AS). There isconcern whether debris embolization and stroke risksare elevated following TAVR.1 It is thus uncertainwhether TAVR will be an equally acceptable option forlower-risk patients who have excellent outcomesfollowing traditional AVR. In addition, the incidence ofpost-TAVR perivalvular leaks (PVLs) is higher thanconventional AVR and associated with increasedmortality.2 Patients who are candidates for convention-al surgical AVR may potentially benefit from shortenedcardiopulmonary-bypass time. Sutureless valve tech-nology for surgical AVR may facilitate the operationthrough smaller incisions, in amore expeditiousmannerowing to the ability to anchor a pericardial prosthesiswithout the need for sutures. These potential benefitsbecome more attractive if the incidence of postopera-tive PVL isminimal.We report the first eight implants of

the PERCEVAL S sutureless valve (Sorin group, Arvada,CO, USA) in the United States at two centers (MayoClinic and Montefiore Medical Center/Albert EinsteinCollege of Medicine) as part of the US Food and DrugAdministration Investigational Device Exemption (FDAIDE) Trial.

METHODS

The PERCEVAL S valve (Fig. 1, panel D) is a bovinepericardium bioprosthesis assembled on a self-expand-ing 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, panelD, b.), and its ability to applymoderate radial force to theimplant site allows firm anchoring, avoiding PVL. Video1 demonstrates the surgical procedure: A limitedsternotomy or minithoracotomy is followed by a smallaortotomy with native aortic valve and calcific debrisexcision, and subsequent sizing of the annulus. Theappropriately sized valve is thenmounted and collapsedonto the holder (figure, panel E). Three temporarysutures are used to guide the valve into the annulus.These sutures are subsequently removed. Once thevalve has been completely deployed, the inflow ring isballoon dilated at 4 atm for 30 seconds. Followingverification of complete contact between the inflowring and the annulus, with appropriate sinus strutposition (figure, panel F), the aortotomy is closed. Post-bypass transesophageal echocardiogram verifies

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

490 © 2014 Wiley Periodicals, Inc.

appropriate inflow and outflow ring seating and fullsystolic cusp excursion, and color flow Doppler is usedto rule out the presence of PVL under physiologicconditions (figure, panels G, H, and I, Videos 2 and 3).The Institutional Review Board at participating institu-tions approved the trial.

The PERCEVAL FDA IDE trial is a prospective, non-randomized, multicenter US clinical trial designed toevaluate the safety and survival rates for the suturelessvalve as compared to appropriate historical controls(http://clinicaltrials.gov/ct2/show/NCT01368666). Eligi-ble patients are adults with severe AS, annular sizebetween 19 and 25mm, and sinotubular junction-to-

annulus ratio <1.3 as determined by echocardiography(figure, panels A and B). Allowable concomitantprocedures include coronary bypass grafting, left atrialappendage ligation, and septal myectomy.

RESULTS

The table details the first eight US patients whohave undergone the procedure. Ages ranged from 72to 91 years (mean 82� 6 years) with STS scoresvarying between low and upper-intermediate surgicalrisk (mean STS mortality 5�2%). Overall bypasstime was 72� 38minutes for the entire group, and

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 21mm. (B) Prebypass diastolic long-axis view withsinuses (31mm) and STJ (25mm) measurements. (C) Prebypass diastolic long-axis view with STJ height (25mm) measured fromannulus to STJ. (D) PERCEVAL S sutureless valve: a, outflow ring for STJ; b, sinusoidal strut for anchoring to Valsalva sinuses (shortarrow) 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 andoutflow ring is above. (F) Deployed PERCEVAL S valve as viewed from the supero-anterior position. The expanded valve is seen inplacewith the sinusoidal strut (arrow) conforming to the contour of the sinus of Valsalva. (G) Postbypass long-axis view shows awell-seated valve with wide cusp systolic excursion. Anterior and posterior aspects of the outflow ring at STJ are shown (arrows). SeeVideo 2. (H) Postbypass short-axis view shows wide systolic excursion of cusps. (I) Postbypass diastolic short-axis color-flow frameshows 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.

J CARD SURG MICHELENA, ET AL. 4912014;29:490–493 FIRST SUTURELESS US

58�16minutes for the six patients undergoing AVRwithout CABG. Hospital length of stay was 9� 4 days.There were no perioperative strokes or deaths and noPVL on postbypass or predischarge echocardiography(Table 1). There were no cases of patient-prosthesismismatch (aortic valve index of 0.94�0.2 cm2/m2). At30 days, there were no strokes or deaths, and noreadmissions. There were three instances of perioper-ative pacemaker placement due to high-degree atrio-ventricular block.

DISCUSSION

This report details initial PERCEVAL S implants in theUnited States, treating severe AS in low-to-upperintermediate risk patients. The absence of majorsurgical complications, identifiable reductions in by-pass/cross-clamp times, and complete abrogation ofPVL are potentially appealing features of this noveltherapeutic modality for severe calcific AS.

Since the first implant in humans in 2007 thePERCEVAL sutureless heart valve has been investigat-ed in four clinical trials. The PERCEVAL Pilot trial(V10601) enrolled 30 patients in three European centersand five-year follow-up is pending. The PERCEVAL

Pivotal trial (V10801) included 150 patients in nineEuropean centers, and the results will be reportedwhen three-year follow-up is obtained. The CAVALIERtrial (TPS001) enrolled 658 patients in 25 Europeancenters and will report follow-up at five years. Thecurrent FDA IDE Trial (TPS002) study was designed toenroll 300 patients at 12 US centers and follow-up willbe performed to five years. The PERCEVAL valvereceived CE mark approval in 2011 and is available inmore than 30 countries worldwide, with a total of morethan 5,000 implants and over 200 active centers.

It should be noted that preliminary data presented inthis report are derived only from the first two centersimplanting the PERCEVAL valve in the United States. Itis too early to derive learning points from thispreliminary experience. Although bicuspid valve pathol-ogy is not contraindicated, implantation of the valve inthis patient population is not recommended early in theindividual surgical experience. If further diminution incross-clamp and bypass times occurs following mas-tery of the learning curve, sutureless valve technologycould potentially convey benefit in high-risk patients orthosewhere aminimally invasive incision is utilized. Theability to fully ascertain the risk of pacemaker implanta-tion following the analysis of trial data will permit

TABLE 1First Eight US PERCEVAL S Implants

Variable MAYO1 MAYO2 MAYO3 MAYO4 MAYO5 MMC1 MMC2 MMC3

PreoperativeSex Female Male Male Female Female Female Male MaleAge, years 82 72 91 82 88 79 81 78Body mass index 38 32 29 36 23 29 25 21STS mortality, % 3 2 9 4 8 5 5 5STS morbi-mortality, % 18 12 38 24 28 24 27 26Creatinine, mg% 1.1 1.0 1.4 0.8 0.9 0.8 1.4 1.1Ejection fraction, % 70 58 71 65 73 60 65 36Annulus, mm 21 25 22 22 22 22 21 22Sinotubular junction, mm 25 31 27 27 25 23 23 26AV mean gradient, mmHg 60 42 48 41 90 32 28 72AV area, cm2 0.85 0.95 0.81 0.82 0.47 0.57 0.42 0.32Aortic regurgitation Trivial Trivial No No Mild Mild Mild Moderate

PerioperativePERCEVAL S size Medium Large Large Large Medium Small Large LargeOther procedure No No LAA exclusion CABGx2 No No CABGx3 NoCross-clamp time, min 48 57 42 58 21 45 133 48Bypass time, min 55 66 56 68 28 71 159 69Reoperation for bleeding No No No No No No Yes� NoInfection No No No No No No No NoRenal failure No No No No No No No NoLength of stay, days 6 4 9 7 5 16 15 9Pacemaker placement No No Yes No No Yes Yes NoStroke No No No No No No No NoDeath No No No No No No No No

Predischarge echocardiogramEjection fraction 65 60 68 70 58 60 65 45AV mean gradient, mmHg 22 16 9 14 17 19 9 10AV area, cm2 1.4 1.8 2.5 2.0 1.6 1.5 1.6 1.2AV area index, cm2/m2 0.69 0.78 1.3 1.1 0.99 0.92 0.96 0.79Aortic regurgitation No Trivial No No Trivial No No NoPerivalvular regurgitation No No No No No No No No

�Platelet dysfunction.LAA, left atrial appendage; CABG, coronary artery bypass surgery; MAYO, Mayo Clinic Rochester; MMC, Montefiore MedicalCenter; AV, aortic valve.

492 MICHELENA, ET AL. J CARD SURGFIRST SUTURELESS US 2014;29:490–493

comparison to surgical and transcatheter approaches.Complete analysis of the FDA IDE Trial studying safetyand success rates will be essential before furtherconclusions can be drawn.

REFERENCES

1. Daneault B, Kirtane AJ, Kodali SK, et al: Stroke associated

with surgical and transcatheter treatment of aortic steno-

sis: A comprehensive review. J Am Coll Cardiol 2011;

58:2143–2150.

2. Kodali SK, Williams MR, Smith CR, et al: Two-year

outcomes after transcatheter or surgical aortic-valve

replacement. N Engl J Med 2012;366:1686–1695.

3. Folliguet TA, Laborde F, Zannis K, et al: Sutureless perceval

aortic valve replacement: Results of twoEuropean centers.

Ann Thorac Surg 2012;93(5):1483–1488.

SUPPORTING INFORMATION

Additional supporting information may be found in theonline version of this article at the publisher’s website.

Video S1. Intraoperative video demonstrating debride-ment of native aortic valve, followed by sizing, guide-suture placement, valve deployment, inspection, andaortotomy closure.Video S2. Postbypass intraoperative-echocardiogramlong-axis view demonstrates a well-seated biopros-thesis with ample systolic cusp excursion. See figure,panel G.Video S3. Postbypass intraoperative-echocardiogramshort-axis view with color flow Doppler demonstratesno evidence of valvular or perivalvular leak with clearevidence of diastolic coronary flow. See figure, panel I.

J CARD SURG MICHELENA, ET AL. 4932014;29:490–493 FIRST SUTURELESS US