First uses of HAART 300 rings for aortic valve repair in Poland – 4 case studies

Introduction

The surgical techniques used for aortic valve repair are constantly improving [1]. Based on the concept of functional aortic annulus (FAA) proposed by El-Khoury (2009), most of the recent innovations focused on the stabilization of the atrioventricular junction (AVJ) [2, 3].
From Cabrol’s subcommissural annuloplasty, through Lansac’s external band and David’s partial external band, to Schäfers’s suture annuloplasty, the goal was to achieve the optimal stabilization of the atrioventricular junction.
Still, none of the methods mentioned above restored the natural, elliptical shape of the aortic ostium.
The use of an internal geometric annuloplasty ring (HAART), proposed by Rankin in 2011, not only restores the appropriate dimensions of the AVJ, but also stabilizes it and, most importantly, reconfigures the aortic ostium to its optimal, elliptical shape [4].
The construction of the HAART ring was based on mathematical calculations obtained by analyzing human aortic valves (both harvested from cadavers and observed intravitally with contrast-enhanced computed tomography) [5, 6] (Fig. 1).
The HAART rings are available as HAART 300, for tricuspid aortic valve repair, and HAART 200, for bicuspid valves (Fig. 2).
Moreover, the HAART 200 ring reconfigures the location of the commissures of an insufficient bicuspid aortic valve to the 50/50 position, which significantly facilitates cusp correction and, as a result, comprehensive valve repair [7].
The titanium stent of the ring is coated with Dacron fabric, while the number of “posts” (angled 10 degrees outwards to ease implantation) depends on the number of commissures – two for the bicuspid valve and three for the tricuspid valve.

Aim

The aim of the study is to present the patient qualification criteria, surgical treatment, as well as short- and medium-term postoperative results of the first 4 HAART 300 ring implantations conducted in Poland for aortic valve repair.

Material and methods

The patients selected for the first 3 aortic valve repair procedures with the use of HAART 300 rings suffered from tricuspid aortic valve insufficiency and ascending aortic aneurysm (type IA insufficiency – 2 patients) and aneurysm of the sinuses of Valsalva – Marfan syndrome (type IB insufficiency – 1 patient).
The fourth patient qualified for aortic valve reconstruction with use of the HAART 300 ring exhibited right coronary cusp (RCC) prolapse without dilation of the ascending aorta (type II insufficiency).
The selection of properly sized rings for aortic valve repair was possible thanks to the HAART 301 measurement set with 19, 21, 23, and 25-mm spherical “sizers” (AVJ size after reconstruction depends on the size of the implanted ring).
The abovementioned spherical “sizers” of the HAART 301 set were consecutively placed in the sinuses of Valsalva to measure the length of the free edges of individual aortic cusps (length – L).
An appropriate size of the HAART 300 ring was selected for implantation based on the desired size of the ring after reconstruction (diameter – D), which should be D = L/1.5 [13].
All presented patients underwent preoperative measurements of the gH (geometric height) of aortic cusps, which exceeded 18 mm, enabling effective valve repair.
The method of implantation consists in placing 3 Cabrol’s sutures under the commissures (through the ring), while the remaining sutures are placed around the ring once it is brought below the native aortic cusps.
Monofilament Prolene 4-0 RB-1 sutures are used for the implantation. After exiting under the aortic cusps, they are tied inside the sinuses of Valsalva in such a way that the knots do not interfere with the movement of the cusps [8, 9].
In patients with ascending aortic aneurysms, supracoronary implantation of an ascending aortic prosthesis was performed after the implantation of the HAART 300 ring. In the patient with Marfan syndrome, Yacoub’s remodeling was performed using a prosthesis with artificial sinuses of Valsalva.
The diameters of the implanted prostheses were 5–7 mm larger than the size of the implanted rings (in accordance with the principles of remodeling and reimplantation techniques used in aortic valve insufficiency) [14].
The stabilization and reconfiguration of AVJ achieved with previous implantation of an internal HAART 300 ring facilitates the implantation of vascular prostheses in the areas of the aortic bulb and the ascending aorta as well as the reconstruction of aortic cusps.

Results

All patients undergoing repair of insufficient aortic valves with the use of HAART 300 rings exhibited good immediate, short-, and medium-term repair outcomes.
Intraoperative assessment was based on eH (effective height) measurements of the reconstructed cusps, which were between 10 and 11 mm for 3 of the presented patients and 12 mm for the patient with Marfan syndrome.
Immediate assessment was based on TEE examination in the operating theater, while short-term assessment – on TTE on the 6th postoperative day.
Medium-term assessment 3, 6, and 12 months after the surgical treatment was based on 3D TTE examination [10, 11].
In TTE there was a correlation between the size of AVJ and the size of the implanted ring.
In 1 patient, echocardiographic examination revealed residual valve regurgitation after the reconstruction; in the remaining 3, TTE showed minor aortic valve insufficiency.
Follow-up 3D TTE conducted 3, 6, and 12 months after the surgery confirmed the stability of the repair and residual/minor gradient through the implanted rings (without any hemodynamic significance) [12].
Below we present the results of echocardiographic examinations: preoperative (top image) and postoperative with an implanted HAART 300 ring (bottom image) of the described 4 patients; all examination results are presented in Table I.

Patient 1

Patient 1, female, age 68. Ascending aortic aneurysm (diameter: 56 mm). Moderate central aortic insufficiency (grade 2), type IA. NYHA II, CCS 1, EF 57%, coronarography: no lesions. Surgical procedure (first implantation of a HAART 300 ring in Poland – 28.06.2016). AVP HAART 300 (ring 19) plus supracoronary AoAsc graft (Jotec 26 mm). Cardiopulmonary bypass – 210 min. Aortic cross-clamping time – 153 min. Crystalloid cardioplegia (Custodiol). Follow-up TEE in the operating theater – after reconstruction – residual/minor central AI (grade 0/1). Intraoperative and postoperative course uneventful. Discharged home on the 7th postoperative day. Follow-up TTE after 3, 6, and 12 months after surgical treatment – residual/minor central AI – stable image. Good medium-term result of valve repair (Fig. 3).

Patient 2

Patient 2, male, age 24. Marfan syndrome. Aortic bulb aneurysm (diameter: 51 mm). Moderate central aortic insufficiency (grade 2), type IB. NYHA I, CCS 1, EF 54%. Surgical procedure – AVP HAART 300 (ring 23) plus remodeling with Yacoub’s method (prosthesis with sinuses of Valsalva – Vascutek Terumo 28 mm).
Cardiopulmonary bypass – 261 min. Aortic cross-clamping time – 209 min. Crystalloid cardioplegia (Custo-diol). Additional myocardial protection with hypothermic left heart jacket (HLHJ). Follow-up TEE in the operating theater – after reconstruction – residual/minor central AI (grade 0/1). Intraoperative course uneventful. Discharged home on the 9th postoperative day. Late pericardial drainage due to fluid accumulation in postoperative course (2 weeks after surgery). Follow-up TTE after 3, 6, and 12 months after surgical treatment – residual/minor central AI – stable image. Good medium-term result of valve repair (Fig. 4).

Patient 3

Patient 3, male, age 58. Ascending aortic aneurysm (diameter: 58 mm). Moderate central aortic insufficiency (grade 2), type IA. NYHA II, CCS 1, EF 62%, coronarography: no lesions. Surgical procedure – AVP HAART 300 (ring 21) plus supracoronary AoAsc graft (Jotec 28 mm).
Cardiopulmonary bypass – 120 min. Aortic cross-clamping time – 81 min. Crystalloid cardioplegia (Custodiol). Follow-up TEE in the operating theater – after reconstruction – residual insufficiency (grade 0). Intraoperative and postoperative course uneventful. Discharged home on the 6th postoperative day. Follow-up TTE after 3, 6, and 12 months after surgical treatment – residual insufficiency, stable image. Good medium-term result of valve repair (Fig. 5).

Patient 4

Patient 4, male, age 51. Moderate tricuspid aortic valve insufficiency (grade 3), type II. Right coronary cusp prolapsed. NYHA II, CCS 1, EF 50%, coronarography: no lesions. Surgical procedure – AVP HAART 300 (ring 21) plus RCC plication (2x Prolene 6-0).
Cardiopulmonary bypass – 137 min. Aortic cross-clamp-ing time – 114 min. Crystalloid cardioplegia (Custodiol). Follow-up TTE in the operating theater – moderate/minor AI – jet towards AML (grade 0/1). Intraoperative and postoperative course uneventful. Discharged home on the 6th postoperative day. Follow-up TTE after 3, 6, and 6 months after surgical treatment – moderate/minor cen-tral AI – jet towards AML (grade 0/1). Good medium-term result of valve repair, but, due to residual RCC prolapse, the patient requires more frequent echocardiographic follow-up examinations (Fig. 6).

Conclusions

The presented method for aortic valve repair successfully restores the size of the atrioventricular junction (AVJ) to the physiological norm calculated for a given patient (established with the use of the HAART 301 measurement set). Implantation of a HAART 300 ring enabled the reconfiguration of the aortic ostium from round and dilated back to physiological – elliptical. The HAART 300 rings, thanks to their construction (rigid rings), permanently stabilize the atrioventricular junction (AVJ) and, as a result, facilitate the reconstruction of insufficient aortic valves, including the plication of cusps in cases of prolapse.

Disclosure

Professor J. S. Rankin is a consultant for BioStable. Others authors report no conflict of interest.

References

1. Boodhwani M, El Khoury G. Aortic valve repair: indications and outcomes”. Curr Cardiol Rep 2014; 16: 490.
2. El Khoury G, Glineur D, Rubay J, Verhelst R, d’Udekem d’Acoz Y, Poncelet A, Astarci P, Noirhomme P, Van Dyck M. Functional classification of aortic root/valve abnormalities and their correlation with ethiologies and surgical procedures. Curr Opin Cardiol 2005; 20: 115-121.
3. Boodhwani M, de Kerchove L, Glineur D, Poncelet A, Rubay J, Astarci P, Verhelst R, Noirhomme P, El-Khoury G. Repair-oriented classification of aortic insufficiency: impact on surgical techniques and clinical outcomes. J Thorac Cardiovasc Surg 2009; 137: 286-294.
4. Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg 2016; 49: 987-993.
5. Crooke PS, Beavan LA, Griffin CD, Mazzitelli D, Rankin JS. Design characteristics of a three-dimensional geometric aortic valve annuloplasty ring. Innovations (Phila) 2013; 8: 364-370.
6. Crooke PS, Beavan LA, Griffin CD, Mazzitelli D, Rankin JS. A geometric model of the normal human aortic root and design of a fully anatomic aortic root graft. Innovations (Phila) 2015; 10: 57-62.
7. Mazzitelli D, Pfeifer S, Rankin JS,Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A regulated trial of bicuspid aortic valve repair supported by geometric ring annuloplasty. Ann Thorac Surg 2015; 99: 2010-2016.
8. Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Krane M, Crooke PS, Cohn WE, Opitz A, Schreiber C, Lange R. Early results after implantation of a new geometric annuloplasty ring for aortic valve repair. Ann Thorac Surg 2013; 95: 94-97.
9. Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg 2014; 45: 426-430.
10. le Polain de Waroux JB, Pouleur AC, Goffinet C, Vancraeynest D, Van Dyck M, Robert A, Gerber BL, Pasquet A, El Khoury G, Vanoverschelde JL. Functional anatomy of aortic regurgitation: accuracy, prediction of surgical reparability, and outcome implications of transesophageal echocardiography. Circulation 2007; 116 (11 Suppl): 1264-1269.
11. Van Dyck MJ, Watremez C, Boodhwani M, Vanoverschelde JL, El Khoury G. Transesophageal echocardiographic evaluation during aortic valve repair surgery. Anesth Analg 2010; 111: 59-70.
12. Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg 2014; 148: 168-175.
13. Jasiński MJ, Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Weber A, Friedrich I, Glauber M, Pfeifer S, Micelli A, Klokocownik T, Juściński JH, Wei LM, Badh-war V. Leaflet dimensions as a guide to remodeling annuloplasty during aortic valve repair. Submitted for publication 2017.
14. Rankin JS, Fischlein T. Geometric ring annuloplasty for aortic valve repair during aortic aneurysm surgery: 2-year clinical trial results. Submitted for publication 2017.