Catheterization and Cardiovascular Interventions 87:993–995 (2016)
Transfemoral Aortic Valve Implantation in Pure Native Aortic Valve Insufficiency Using the Repositionable and Retrievable Lotus Valve € hrle,* MD, Christoph Rodewald, MD, and Wolfgang Rottbauer, MD Jochen Wo Transfemoral aortic valve implantation (TAVI) for the treatment of pure native aortic insufficiency is not routine clinical practice. Absent cusp calcification, missing landmarks in combination with no perfect valve control during release with first-generation TAVI devices resulted in a high rate for need of a second valve or relevant residual aortic insufficiency. We report the first case with a native pure aortic valve insufficiency at high surgical risk successfully treated by implantation of the repositionable and completely retrievable Lotus valve, resulting in a well-controlled and safe procedure with no residual aortic insufficiency. VC 2015 Wiley Periodicals, Inc. Key words: AVD—aortic valve disease; TVI—transcatheter valve implantation; AVDP— aortic valve disease; percutaneous intervention
INTRODUCTION
There is very limited experience with transfemoral aortic valve implantation (TAVI) for the treatment of patients with pure native aortic valve insufficiency (NAVI). The absence of cusp calcification in combination with the limited control during the release of firstgeneration TAVI devices resulted in a frequent need of a second valve, surgical conversion despite the increased perioperative risk and a substantial rate of relevant residual aortic insufficiency in the largest multicenter experience including 42 patients [1]. Although with TAVI mortality rate was significantly lower compared to surgical valve replacement in high-risk patients with severe aortic stenosis [2], the treatment of NAVI patients remained a surgical domain even in high-risk patients. However, in such patients, the use of a modern second-generation TAVI device may be a future option. We report for the first time the use of the second-generation Lotus valve for the treatment of a NAVI patient at high surgical risk. The mechanically deployed Lotus valve consists of a nitinol frame in combination with an Adpative SealTM technology. This sealing feature is located at the proximal frame placed in the left ventricular outflow tract (LVOT) and minimizes the risk of postprocedural aortic insufficiency. There are three key features allowing safe use of this valve type for the treatment of patients with NAVI. First, there is an early valve-operating function which eliminates a hemodynamic instability during the implantation of the Lotus valve and which eliminates the need for rapid pacing during valve positioning. Second, owing to the dedicated release mechaC 2015 Wiley Periodicals, Inc. V
nism, the valve can be repositioned and also completely retrieved if operators are unsatisfied with the position or with the stability of anchoring in the noncalcified annulus of patients with NAVI. Third, the valve is released after complete mechanically deployment being in its final configuration and final position.
CASE REPORT
This first NAVI patient treated with the Lotus valve was a 78-year-old woman with severe aortic insufficiency suffering from dyspnea NYHA class III. The risk of surgical valve replacement was significantly increased owing to severe pulmonary disease, history of stroke and a history of repetitive gastrointestinal bleedings with anticoagulation owing to atrial fibrillation. The patient underwent cardiac catheterization, transthoracic, and transesophageal echocardiography Additional Supporting Information may be found in the online version of this article. Department of Internal Medicine II, University of Ulm, Ulm, Germany Conflict of interest: Nothing to report. *Correspondence to: Jochen W€ohrle, Department of Internal Medicine II, University of Ulm, Ulm, Germany. E-mail [email protected] Received 6 April 2015; Revision accepted 19 May 2015 DOI: 10.1002/ccd.26062 Published online 23 June 2015 in Wiley Online Library (wileyonlinelibrary.com)
994
€ hrle et al. Wo
Fig. 1. Preprocedural aortography with 40-mL contrast, demonstrating severe aortic insufficiency. The missing calcification of the aortic cusps should be noted.
and multislice computer tomography (CT; Philips Brilliance i-CT 256; Philips, The Netherlands). The measurements were carried out with a dedicated software (3mensio 7.0 software, Pie Medical Imaging, Maastricht, The Netherlands) [3]. In the annulus, the perimeter derived mean diameter was 25.3 mm, area derived mean diameter 25.2 mm, and the area 499 mm2. The measurements in LVOT (distal to annulus, 4 mm) showed a perimeter derived mean diameter of 23.8 mm, area derived mean diameter of 23.4 mm, and an area of 430 mm2. Distance from the annulus to the ostium of right coronary artery was 20 mm and to the ostium of the left coronary artery 18 mm. CT scan and echocardiography demonstrated no calcification of the aortic cusps as well as no calcification in the LVOT. Based on the CT measurements, we decided to implant a 27-mm Lotus valve (Boston Scientific, Marlborough, MA), allowing an oversizing of absolute 1.5 mm in relation to the perimeter-derived diameter of the annulus. Oversizing was 15% in relation to annulus area. The procedure was performed in a hybrid catheterization laboratory with local anesthesia and fluoroscopic guidance. A pigtail catheter in the noncoronary cusp was used as landmark during valve implantation. Preprocedural aortography demonstrated severe aortic insufficiency (Fig. 1, Supporting Information Movie 1). A small Safari wire (Boston Scientific, Marlborough, MA) was inserted via a Pigtail catheter in the left ventricle. The valve was positioned in the annulus in an identical way as for the treatment of aortic valve stenosis. Owing to the missing calcification and missing anatomical landmarks, the first position was too deep in
Fig. 2. Postprocedural aortography with 40-mL contrast, demonstrating an optimal position of the 27-mm Lotus valve without residual aortic insufficiency.
the LVOT. After repositioning, the Lotus valve was in the correct position demonstrating no residual aortic insufficiency by aortography. The compression of the valve frame and stability tests by pushing of the guidewire and pulling on the delivery catheter demonstrated a good anchoring of the valve prior to final release. Final result demonstrated a perfect position without any residual aortic insufficiency (Fig. 2, Supporting Information Movie 2). DISCUSSION
Implantation of the repositionable Lotus valve has been limited to patients with severe aortic stenosis. In Reprise I and II studies, there was no need for a second valve and the Lotus valve was in all cases in the correct position [4,5]. We now demonstrate that this mechanically deployed valve is a future treatment option in patients with NAVI at high risk for surgical valve replacement. During the implantation procedure, the radial strength of the frame allows the valve to reach the final diameter by mechanical deployment. The early valve operation and the controlled release do not require rapid pacing. Repositioning of the valve can be easily performed by rotating the control knob as described elsewhere [6]. In case the valve is not sufficiently anchored, it can be completely retrieved translating TAVI for patients with NAVI in a safe and controlled procedure without the observed high risk of valve embolization or relevant residual aortic insufficiency seen with first-generation devices [1]. Patients with severe aortic stenosis or insufficiency without valve replacement have a poor prognosis [7–10]. Although TAVI in patients with high surgical risk with severe aortic stenosis is a well-proven
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Repositionable Lotus Valve for Pure NAVI
treatment [2,4,5,9–13], there is very limited experience with TAVI in patients with NAVI owing to missing cusp calcification, resulting in a difficult positioning, limited anchoring, and missing landmarks. With the controlled and repositionable Lotus valve, those patients have the option for an alternative and safe treatment. Furthermore, with first-generation TAVI devices such as the CoreValve prosthesis rapid pacing with 150–180 beats/min was required to improve valve stability and to reduce the risk of valve dislocation. In the largest multicenter experience with 42 patients with NAVI, the use of CoreValve resulted in a 19% need for a second valve for the treatment of residual aortic insufficiency. In all of these nine patients, there was no valve calcification documented [1] similar to our case. Furthermore, final result in nine patients was a moderate aortic insufficiency, resulting in a Valve Academic Research Consortium (VARC-II) [14] defined procedural success rate of only 74%.
4.
5.
6.
7.
8.
9.
CONCLUSIONS
In conclusion, in selected patients with severe native pure aortic valve insufficiency and high surgical risk, the implantation of the repositionable and completely retrievable Lotus valve is a safe and controlled procedure, resulting in no residual aortic insufficiency.
10.
11.
12.
REFERENCES 1. Roy DA, Schaefer, U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol 2013;61:1577–1584. 2. Adams DH, Popma, JJ, Reardon MJ, et al. Transcatheter aorticvalve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–1798. 3. Stortecky S, Heg D, Gloekler S, Wenaweser P, Windecker S, Buellesfeld L. Accuracy and reproducibility of aortic annulus sizing using a dedicated three-dimensional computed tomogra-
13.
14.
995
phy reconstruction tool in patients evaluated for transcatheter aortic valve replacement. EuroIntervention 2014;10:339–346. Meredith IT, Worthley, SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention 2014;9:1264–1270. Meredith Am IT, Walters, DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-Day primary endpoint results from the REPRISE II study. J Am Coll Cardiol 2014;64:1339–1348. Meredith IT, Hood KL, Haratani N, Allocco DJ, Dawkins KD. Boston Scientific Lotus Valve. EuroIntervention 2012;8:Q70– Q74. Dujardin KS, Enriquez-Sarano M, Schaff HV, Bailey KR, Seward JB, Tajik AJ. Mortality and morbidity of aortic regurgitation in clinical practice. A long term follow up study. Circulation 1999;99:1851–1857. Tarasoutchi F, Grinberg, M, Ramires JA, et al. Ten-year laboratory follow up after application of a symptom-based therapeutic strategy to patients with severe chronic aortic regurgitation of predominant rheumatic etiology. J Am Coll Cardiol 2003;41: 1316–1324. Leon MB, Smith, CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607. Makkar RR, Fontana, GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696–1704. Smith CR, Leon, MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 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. Mack MJ, Leon MB, Smith CR, et al. 5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet 2015; S0140-6736(15)60308-7. Kappetein AP, Head, SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438–1454.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Transfemoral Aortic Valve Implantation in Pure Native Aortic Valve Insufficiency Using the Repositionable and Retrievable Lotus Valve € hrle,* MD, Christoph Rodewald, MD, and Wolfgang Rottbauer, MD Jochen Wo Transfemoral aortic valve implantation (TAVI) for the treatment of pure native aortic insufficiency is not routine clinical practice. Absent cusp calcification, missing landmarks in combination with no perfect valve control during release with first-generation TAVI devices resulted in a high rate for need of a second valve or relevant residual aortic insufficiency. We report the first case with a native pure aortic valve insufficiency at high surgical risk successfully treated by implantation of the repositionable and completely retrievable Lotus valve, resulting in a well-controlled and safe procedure with no residual aortic insufficiency. VC 2015 Wiley Periodicals, Inc. Key words: AVD—aortic valve disease; TVI—transcatheter valve implantation; AVDP— aortic valve disease; percutaneous intervention
INTRODUCTION
There is very limited experience with transfemoral aortic valve implantation (TAVI) for the treatment of patients with pure native aortic valve insufficiency (NAVI). The absence of cusp calcification in combination with the limited control during the release of firstgeneration TAVI devices resulted in a frequent need of a second valve, surgical conversion despite the increased perioperative risk and a substantial rate of relevant residual aortic insufficiency in the largest multicenter experience including 42 patients [1]. Although with TAVI mortality rate was significantly lower compared to surgical valve replacement in high-risk patients with severe aortic stenosis [2], the treatment of NAVI patients remained a surgical domain even in high-risk patients. However, in such patients, the use of a modern second-generation TAVI device may be a future option. We report for the first time the use of the second-generation Lotus valve for the treatment of a NAVI patient at high surgical risk. The mechanically deployed Lotus valve consists of a nitinol frame in combination with an Adpative SealTM technology. This sealing feature is located at the proximal frame placed in the left ventricular outflow tract (LVOT) and minimizes the risk of postprocedural aortic insufficiency. There are three key features allowing safe use of this valve type for the treatment of patients with NAVI. First, there is an early valve-operating function which eliminates a hemodynamic instability during the implantation of the Lotus valve and which eliminates the need for rapid pacing during valve positioning. Second, owing to the dedicated release mechaC 2015 Wiley Periodicals, Inc. V
nism, the valve can be repositioned and also completely retrieved if operators are unsatisfied with the position or with the stability of anchoring in the noncalcified annulus of patients with NAVI. Third, the valve is released after complete mechanically deployment being in its final configuration and final position.
CASE REPORT
This first NAVI patient treated with the Lotus valve was a 78-year-old woman with severe aortic insufficiency suffering from dyspnea NYHA class III. The risk of surgical valve replacement was significantly increased owing to severe pulmonary disease, history of stroke and a history of repetitive gastrointestinal bleedings with anticoagulation owing to atrial fibrillation. The patient underwent cardiac catheterization, transthoracic, and transesophageal echocardiography Additional Supporting Information may be found in the online version of this article. Department of Internal Medicine II, University of Ulm, Ulm, Germany Conflict of interest: Nothing to report. *Correspondence to: Jochen W€ohrle, Department of Internal Medicine II, University of Ulm, Ulm, Germany. E-mail [email protected] Received 6 April 2015; Revision accepted 19 May 2015 DOI: 10.1002/ccd.26062 Published online 23 June 2015 in Wiley Online Library (wileyonlinelibrary.com)
994
€ hrle et al. Wo
Fig. 1. Preprocedural aortography with 40-mL contrast, demonstrating severe aortic insufficiency. The missing calcification of the aortic cusps should be noted.
and multislice computer tomography (CT; Philips Brilliance i-CT 256; Philips, The Netherlands). The measurements were carried out with a dedicated software (3mensio 7.0 software, Pie Medical Imaging, Maastricht, The Netherlands) [3]. In the annulus, the perimeter derived mean diameter was 25.3 mm, area derived mean diameter 25.2 mm, and the area 499 mm2. The measurements in LVOT (distal to annulus, 4 mm) showed a perimeter derived mean diameter of 23.8 mm, area derived mean diameter of 23.4 mm, and an area of 430 mm2. Distance from the annulus to the ostium of right coronary artery was 20 mm and to the ostium of the left coronary artery 18 mm. CT scan and echocardiography demonstrated no calcification of the aortic cusps as well as no calcification in the LVOT. Based on the CT measurements, we decided to implant a 27-mm Lotus valve (Boston Scientific, Marlborough, MA), allowing an oversizing of absolute 1.5 mm in relation to the perimeter-derived diameter of the annulus. Oversizing was 15% in relation to annulus area. The procedure was performed in a hybrid catheterization laboratory with local anesthesia and fluoroscopic guidance. A pigtail catheter in the noncoronary cusp was used as landmark during valve implantation. Preprocedural aortography demonstrated severe aortic insufficiency (Fig. 1, Supporting Information Movie 1). A small Safari wire (Boston Scientific, Marlborough, MA) was inserted via a Pigtail catheter in the left ventricle. The valve was positioned in the annulus in an identical way as for the treatment of aortic valve stenosis. Owing to the missing calcification and missing anatomical landmarks, the first position was too deep in
Fig. 2. Postprocedural aortography with 40-mL contrast, demonstrating an optimal position of the 27-mm Lotus valve without residual aortic insufficiency.
the LVOT. After repositioning, the Lotus valve was in the correct position demonstrating no residual aortic insufficiency by aortography. The compression of the valve frame and stability tests by pushing of the guidewire and pulling on the delivery catheter demonstrated a good anchoring of the valve prior to final release. Final result demonstrated a perfect position without any residual aortic insufficiency (Fig. 2, Supporting Information Movie 2). DISCUSSION
Implantation of the repositionable Lotus valve has been limited to patients with severe aortic stenosis. In Reprise I and II studies, there was no need for a second valve and the Lotus valve was in all cases in the correct position [4,5]. We now demonstrate that this mechanically deployed valve is a future treatment option in patients with NAVI at high risk for surgical valve replacement. During the implantation procedure, the radial strength of the frame allows the valve to reach the final diameter by mechanical deployment. The early valve operation and the controlled release do not require rapid pacing. Repositioning of the valve can be easily performed by rotating the control knob as described elsewhere [6]. In case the valve is not sufficiently anchored, it can be completely retrieved translating TAVI for patients with NAVI in a safe and controlled procedure without the observed high risk of valve embolization or relevant residual aortic insufficiency seen with first-generation devices [1]. Patients with severe aortic stenosis or insufficiency without valve replacement have a poor prognosis [7–10]. Although TAVI in patients with high surgical risk with severe aortic stenosis is a well-proven
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Repositionable Lotus Valve for Pure NAVI
treatment [2,4,5,9–13], there is very limited experience with TAVI in patients with NAVI owing to missing cusp calcification, resulting in a difficult positioning, limited anchoring, and missing landmarks. With the controlled and repositionable Lotus valve, those patients have the option for an alternative and safe treatment. Furthermore, with first-generation TAVI devices such as the CoreValve prosthesis rapid pacing with 150–180 beats/min was required to improve valve stability and to reduce the risk of valve dislocation. In the largest multicenter experience with 42 patients with NAVI, the use of CoreValve resulted in a 19% need for a second valve for the treatment of residual aortic insufficiency. In all of these nine patients, there was no valve calcification documented [1] similar to our case. Furthermore, final result in nine patients was a moderate aortic insufficiency, resulting in a Valve Academic Research Consortium (VARC-II) [14] defined procedural success rate of only 74%.
4.
5.
6.
7.
8.
9.
CONCLUSIONS
In conclusion, in selected patients with severe native pure aortic valve insufficiency and high surgical risk, the implantation of the repositionable and completely retrievable Lotus valve is a safe and controlled procedure, resulting in no residual aortic insufficiency.
10.
11.
12.
REFERENCES 1. Roy DA, Schaefer, U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol 2013;61:1577–1584. 2. Adams DH, Popma, JJ, Reardon MJ, et al. Transcatheter aorticvalve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–1798. 3. Stortecky S, Heg D, Gloekler S, Wenaweser P, Windecker S, Buellesfeld L. Accuracy and reproducibility of aortic annulus sizing using a dedicated three-dimensional computed tomogra-
13.
14.
995
phy reconstruction tool in patients evaluated for transcatheter aortic valve replacement. EuroIntervention 2014;10:339–346. Meredith IT, Worthley, SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention 2014;9:1264–1270. Meredith Am IT, Walters, DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-Day primary endpoint results from the REPRISE II study. J Am Coll Cardiol 2014;64:1339–1348. Meredith IT, Hood KL, Haratani N, Allocco DJ, Dawkins KD. Boston Scientific Lotus Valve. EuroIntervention 2012;8:Q70– Q74. Dujardin KS, Enriquez-Sarano M, Schaff HV, Bailey KR, Seward JB, Tajik AJ. Mortality and morbidity of aortic regurgitation in clinical practice. A long term follow up study. Circulation 1999;99:1851–1857. Tarasoutchi F, Grinberg, M, Ramires JA, et al. Ten-year laboratory follow up after application of a symptom-based therapeutic strategy to patients with severe chronic aortic regurgitation of predominant rheumatic etiology. J Am Coll Cardiol 2003;41: 1316–1324. Leon MB, Smith, CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607. Makkar RR, Fontana, GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696–1704. Smith CR, Leon, MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 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. Mack MJ, Leon MB, Smith CR, et al. 5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet 2015; S0140-6736(15)60308-7. Kappetein AP, Head, SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438–1454.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
