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c 2012 Wiley Periodicals, Inc. 1 SURGICAL TECHNIQUES Transcatheter Aortic Valve Implantation Using the Slow Balloon Inflation Technique: Making Balloon-Expandable Valves Partially Repositionable Michael Mok, M.B.B.S., F.R.A.C.P., Eric Dumont, M.D., Daniel Doyle, M.D., and Josep Rod ´ es-Cabau, M.D. Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada ABSTRACT In transcatheter aortic valve implantation procedures using balloon-expandable valves, the valve is deployed by rapid balloon inflation within a short period of rapid ventricular pacing. This system and de- ployment technique is generally considered to be nonrepositionable. We illustrate with two cases (transapi- cal and transfemoral) the possibility to partially reposition the valve during its deployment if a slow balloon inflation technique were employed—a technique that may minimize the risk of valve mal-positioning and its attendant complications. doi: 10.1111/j.1540-8191.2012.01492.x (J Card Surg 2012; ∗∗ :1-3) Valve malpositioning and/or embolization are among the most concerning complications associated with transcatheter aortic valve implantation (TAVI). 1 The possibility of complete or partial valve reposition- ing might play an important role in avoiding such complications. Although partial valve repositioning is possible with the use of self-expandable valves, balloon-expandable valves are deployed by balloon inflation within a short period of rapid pacing and are considered nonrepositionable. This report illustrates with two cases the possibility to reposition a balloon- expandable valve during its deployment with the use of a slow balloon inflation technique. Case #1 A 91-year-old female was admitted to the hospital with pulmonary edema. Echocardiography revealed a mean aortic valve gradient, valve area, and LVEF Conflict of interest: Dr. Dumont is a consultant for Edwards Life- sciences. Dr. Josep Rod ´ es-Cabau is a consultant for Edwards Life- sciences and St-Jude Medical. The other authors acknowledge no conflict of interest in the submission. Address for correspondence: Josep Rod ´ es-Cabau, M.D., Quebec Heart & Lung Institute, Laval University, 2725 chemin Ste-Foy, G1V 4G5 Quebec City, Quebec, Canada. Fax: +418-6564544; e-mail: [email protected] of 41 mmHg, 0.52 cm 2 , and 45%, respectively. STS score was 6.9%, and the patient was considered a candidate for TAVI because of her advanced age and frailty. A transfemoral 23-mm Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, CA, USA) implantation was planned. Procedural details about transfemoral TAVI have been previously reported. 1 Valve implantation was performed by balloon inflation under rapid pacing (200 bpm) using a slow balloon inflation technique under continuous fluoroscopy (Fig. 1). Displacement of the valve system toward the aorta was observed at the commencement of balloon inflation/valve deployment (Fig. 1A, B). Balloon inflation was stopped while rapid pacing continued and the position of the pigtail catheter in the sinus of Valsalva was maintained. This allowed the repositioning of the transcatheter valve, initially toward the left ventricle (Fig. 1C) and thereafter with a final withdrawal of the valve system towards the aorta (Fig. 1D) to the optimal position before complete balloon inflation and valve deployment (Fig. 1E). Time to full balloon expansion was 9.0 seconds. Image of the valve prosthesis after implantation is shown in Figure 1F. The postoperative period was uneventful and the patient was discharged from the hospital five days after the procedure. Echocardiography showed a residual aortic gradient of 6 mmHg and trivial paravalvular aortic regurgitation. The patient was in NYHA functional class I at 6-month follow-up.

Transcatheter Aortic Valve Implantation Using the Slow Balloon Inflation Technique: Making Balloon-Expandable Valves Partially Repositionable

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Page 1: Transcatheter Aortic Valve Implantation Using the Slow Balloon Inflation Technique: Making Balloon-Expandable Valves Partially Repositionable

c© 2012 Wiley Periodicals, Inc. 1

SURGICAL TECHNIQUES

Transcatheter Aortic ValveImplantation Using the Slow BalloonInflation Technique: MakingBalloon-Expandable Valves PartiallyRepositionableMichael Mok, M.B.B.S., F.R.A.C.P., Eric Dumont, M.D., Daniel Doyle, M.D.,

and Josep Rodes-Cabau, M.D.

Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada

ABSTRACT In transcatheter aortic valve implantation procedures using balloon-expandable valves, the valve

is deployed by rapid balloon inflation within a short period of rapid ventricular pacing. This system and de-

ployment technique is generally considered to be nonrepositionable. We illustrate with two cases (transapi-

cal and transfemoral) the possibility to partially reposition the valve during its deployment if a slow balloon

inflation technique were employed—a technique that may minimize the risk of valve mal-positioning and

its attendant complications. doi: 10.1111/j.1540-8191.2012.01492.x (J Card Surg 2012;∗∗:1-3)

Valve malpositioning and/or embolization are amongthe most concerning complications associated withtranscatheter aortic valve implantation (TAVI).1 Thepossibility of complete or partial valve reposition-ing might play an important role in avoiding suchcomplications. Although partial valve repositioningis possible with the use of self-expandable valves,balloon-expandable valves are deployed by ballooninflation within a short period of rapid pacing and areconsidered nonrepositionable. This report illustrateswith two cases the possibility to reposition a balloon-expandable valve during its deployment with the useof a slow balloon inflation technique.

Case #1

A 91-year-old female was admitted to the hospitalwith pulmonary edema. Echocardiography revealeda mean aortic valve gradient, valve area, and LVEF

Conflict of interest: Dr. Dumont is a consultant for Edwards Life-sciences. Dr. Josep Rodes-Cabau is a consultant for Edwards Life-sciences and St-Jude Medical. The other authors acknowledge noconflict of interest in the submission.

Address for correspondence: Josep Rodes-Cabau, M.D., QuebecHeart & Lung Institute, Laval University, 2725 chemin Ste-Foy, G1V4G5 Quebec City, Quebec, Canada. Fax: +418-6564544; e-mail:[email protected]

of 41 mmHg, 0.52 cm2, and 45%, respectively. STSscore was 6.9%, and the patient was considereda candidate for TAVI because of her advanced ageand frailty. A transfemoral 23-mm Edwards SAPIENXT valve (Edwards Lifesciences, Irvine, CA, USA)implantation was planned. Procedural details abouttransfemoral TAVI have been previously reported.1

Valve implantation was performed by balloon inflationunder rapid pacing (200 bpm) using a slow ballooninflation technique under continuous fluoroscopy(Fig. 1). Displacement of the valve system toward theaorta was observed at the commencement of ballooninflation/valve deployment (Fig. 1A, B). Balloon inflationwas stopped while rapid pacing continued and theposition of the pigtail catheter in the sinus of Valsalvawas maintained. This allowed the repositioning of thetranscatheter valve, initially toward the left ventricle(Fig. 1C) and thereafter with a final withdrawal of thevalve system towards the aorta (Fig. 1D) to the optimalposition before complete balloon inflation and valvedeployment (Fig. 1E). Time to full balloon expansionwas 9.0 seconds. Image of the valve prosthesis afterimplantation is shown in Figure 1F. The postoperativeperiod was uneventful and the patient was dischargedfrom the hospital five days after the procedure.Echocardiography showed a residual aortic gradientof 6 mmHg and trivial paravalvular aortic regurgitation.The patient was in NYHA functional class I at 6-monthfollow-up.

Page 2: Transcatheter Aortic Valve Implantation Using the Slow Balloon Inflation Technique: Making Balloon-Expandable Valves Partially Repositionable

2 MOK, ET AL.REPOSITIONING OF BALLOON-EXPANDABLE VALVES

J CARD SURG2012;**:1-3

Figure 1. Slow balloon inflation technique and repositioning of a balloon-expandable aortic valve implanted via transfemoral ap-proach. (A) Aortic angiography for initial valve positioning. White asterisks indicate the level of the aortic annulus. The transcathetervalve is positioned about half ventricular/half aortic with respect to the aortic annulus. (B) Commencement of balloon inflation metwith aortic displacement of the valve-balloon system. The pigtail catheter is maintained in the sinus of Valsalva during the firstpart of valve deployment to optimize valve positioning. (C) First repositioning of the transcatheter valve by pushing the deliverysystem toward the left ventricle while the valve prosthesis is partially expanded. (D) Second repositioning of the transcathetervalve by pulling back the delivery catheter while the valve prosthesis is partially deployed.(E) Final valve deployment by full balloonexpansion. (F) Aortography immediately after valve implantation showing the correct position of the transcatheter valve and theabsence of aortic regurgitation.

Figure 2. Slow balloon inflation technique and repositioning of a balloon-expandable aortic valve implanted via transapical approach.(A) Aortic angiography for initial valve positioning. Black arrow indicates the aortic end of the transcatheter Edwards SAPIEN valve.White arrow indicates the annulus of the Mitroflow surgical bioprosthesis. The transcatheter valve is positioned about halfaortic/half ventricular with respect to the annulus of the surgical bioprosthesis. (B) Initial balloon inflation and valve deploymentof the transcatheter valve. (C) Aortic displacement of the transcatheter valve during balloon inflation. (D) Repositioning of thetranscatheter valve by pulling back the delivery system toward the left ventricle while the valve prosthesis is partially expanded.(E) Final transcatheter valve deployment by full balloon expansion. (F) Aortography immediately after valve implantation showingthe correct position of the transcatheter valve and the absence of residual aortic regurgitation.

Case #2

A 67-year-old man presented with dyspnea NYHAclass III seven years after aortic valve replacement(Mitroflow 25-mm, Sorin Group, Milano, Italy) andreplacement of the ascending aortic arch for Type A

aortic dissection. Echocardiography showed severeintraprosthetic aortic valve regurgitation and a LVEF of45%. He also had severe chronic renal failure and hisSTS score was 6.1%. The patient was considered acandidate for a “valve-in-valve” TAVI, and a transapicalapproach was selected due to the small diameter of

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J CARD SURG2012;**:1-3

MOK, ET AL.REPOSITIONING OF BALLOON-EXPANDABLE VALVES

3

his femoral arteries. Details about the transapical TAVIprocedure have been previously reported.1 A 23-mmEdwards SAPIEN valve was selected for implantationusing a slow balloon inflation technique under rapidpacing (Fig. 2). There was an initial aortic displace-ment of the valve system at the commencement ofballoon inflation/valve deployment (Fig. 2B). Ballooninflation was paused; the delivery catheter systemwas retracted toward the left ventricle (Fig. 2C) tothe optimal position within the surgical bioprosthesis(Fig. 2D), followed with valve deployment by full bal-loon expansion (Fig. 2E). Time to full balloon expansionwas 7.1 seconds. Final position of the transcathetervalve is shown in Figure 2F. The postoperative periodwas uneventful and the patient was discharged fromthe hospital 7 days after the procedure. Echocardio-graphy showed absence of aortic regurgitation with amean residual gradient of 5 mmHg. The patient wasin NYHA functional class I at 3-month follow up.

DISCUSSION

These two cases illustrate that TAVI using a slowballoon inflation technique is feasible and allows thesafe repositioning of a balloon-expandable valve, both

via the transapical and transfemoral approaches. Aor-tic or ventricular displacement of the transcathetervalve/balloon system is occasionally encountered dur-ing balloon inflation/valve deployment despite rapidventricular pacing and this might lead to valve prosthe-sis malpositioning or embolization.2,3 Although it is dif-ficult to provide an exact balloon inflation speed, slowballoon inflation can be defined as balloon inflation slowenough to allow a pause or stop before full balloon ex-pansion. We believe that a slow inflation-deploymentof the stent-valve system provides an opportunity tooptimize valve positioning and thus potentially reducethe incidence of such complications.

REFERENCES

1. Rodes-Cabau J: Transcatheter aortic valve implanta-tion: Current and future approaches. Nat Rev Cardiol2011;9:15-29.

2. Ali AMA, Altwegg L, Horlick EM, et al: Preventionand management of transcatheter balloon-expandableaortic valve malposition. Catheter Cardiovasc Interv2008;72:573-578.

3. Masson JB, Kovac J, Schuler G, et al: Transcatheter aorticvalve implantation: Review of the nature, management,and avoidance of procedural complications. JACC Cardio-vasc Interv 2009;2:811-820.