International Journal of Cardiology 171 (2014) e113–e116
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Partial clip detachment and posterior mitral leaflet perforation after mitraclip implantation Rodolfo Citro ⁎, Cesare Baldi, Generoso Mastrogiovanni, Angelo Silverio, Eduardo Bossone, Pietro Giudice, Federico Piscione, Giuseppe Di Benedetto Heart Department, University Hospital “San Giovanni di Dio e Ruggi d'Aragona”, Salerno, Italy
a r t i c l e
i n f o
Article history: Received 27 October 2013 Accepted 17 December 2013 Available online 27 December 2013 Keywords: Mitral regurgitation Mitraclip complications Three-dimensional echocardiography
Dear Editor, A 64-year-old woman with a history of essential hypertension, left ventricular systolic dysfunction, chronic obstructive pulmonary disease, and recurrent flash pulmonary edema despite adequate pharmacological therapy was admitted to our hospital for acute decompensated heart failure. Transthoracic echocardiography (TTE) showed a reduced left ventricular ejection fraction (36%), severe mitral regurgitation (MR) (effective regurgitant orifice area of 33 mm2 in mesosystole) and elevated pulmonary artery systolic pressure (55 mmHg). The patient was treated with high-dose intravenous furosemide and non-invasive ventilation. After improvement of her clinical condition, conventional two-dimensional transesophageal echocardiography (TEE) and coronary angiography were planned to establish the etiology of cardiomyopathy and MR, to localize the origin of the regurgitant jet and to assess mitral valve (MV) anatomy. TEE with midesophageal intercommissural (at 60°) and left ventricular outflow tract (at 120°) views revealed a central jet involving the A2-P2 scallops due to symmetric leaflet tethering. The vena contracta was estimated to be 7 mm, and no additional regurgitant jets were visualized. Several parameters that need to be measured for planning MitraClip (MC) (Abbott Vascular, Menlo Park, CA, USA) implantation were also calculated, including tenting area, coaptation depth (11 mm), coaptation length (3.1 mm) and the distance from the fossa ovalis to leaflet coaptation (48 mm). In addition, an estimate ⁎ Corresponding author at: University Hospital “San Giovanni di Dio e Ruggi d'Aragona”, Heart Tower room 810, Largo Città di Ippocrate, Salerno 84131, Italy. Tel.: + 39 089 673377; +39 3473570880(mobile). E-mail address: [email protected] (R. Citro). 0167-5273/$ – see front matter © 2013 Elsevier Ireland. Ltd All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.12.040
of MV area (5.27 cm2) was obtained from the transgastric view. No significant coronary stenosis was observed on coronary angiography. The patient was judged to have severe functional MR by the local “heart team”, including a clinical and interventional cardiologist, an echocardiographer and a cardiac surgeon, and was considered to be amenable to percutaneous treatment because of high surgical risk and patient's preference. After successful transseptal puncture, a MC device was implanted with standard technique under conventional TEE monitoring. The leaflets were grasped by the clip with residual moderate regurgitation. However, given the relatively high transmitral gradient (5.6 mmHg) and the risk for worsening stenosis, a second clip was not implanted. Two months later the patient was readmitted for fatigue and reduced effort tolerance with clinical signs of heart failure. TTE showed recurrence of severe MR due to single leaflet clip attachment to the anterior mitral leaflet (see movies 1 and 2). TEE confirmed partial clip detachment. Additionally, color flow mapping revealed a flow convergence area on the posterior mitral leaflet (Fig. 1), suggesting leaflet perforation that was confirmed by real-time three-dimensional (3D) acquisition (General ElectricVivid E9; GE Vingmed ultrasound —Horten, Norway. Fig. 2; see also movies 3 and 4). Surgical MV replacement was proposed but the patient refused. Moderate to severe MR is a common finding in patients with congestive heart failure, occurring approximately in one third of cases [1]. According to guideline criteria [2], MV surgery is considered the standard treatment for patients with severe MR. However, almost half of patients with heart failure and severe MR are at high risk and are denied surgery because of coexisting comorbidities, advanced left ventricular systolic dysfunction, or old age [3]. MC implantation has rapidly emerged as an alternative treatment option for patients with severe MR who are not amenable to MV surgery. The Endovascular Valve Edge-to-Edge Repair Study (EVEREST I) was the first clinical trial to enroll predominantly patients with degenerative MR, and demonstrated that MC implantation is safe and feasible, with a significant reduction in MR grade (b2 +) observed in 74% of cases [4]. At long-term follow-up, 90.1% of patients were free from death and 76.3% were free from MV surgery; clip detachment was reported in 9% of cases [4]. Of the 32 patients enrolled in the EVEREST II trial undergoing post-clip MV surgery, in 10 cases the indication was partial clip detachment detected procedurally, at discharge, at 30 days and 12 months of follow-up in 3, 1, 5 and 1 patients, respectively [5]. Surgical MV repair or replacement was required in 8 and 2 patients, respectively, but the overall rate of 5% in
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R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
Fig. 1. Upper panels: transesophageal echocardiography (orthogonal view) showing single leaflet attachment of the MitraClip on the anterior mitral leaflet (see dotted arrows). Lower panels: color flow mapping in the same section as the upper panels. A flow convergence area (see solid arrow) can be appreciated in correspondence of the perforation of the posterior mitral leaflet. AML = anterior mitral leaflet; LA = left atrium; and LV = left ventricle.
the EVEREST II trial represents early experience with the novel MC device [6]. Preliminary data from EVEREST II REALISM indicate an even lower rate of single leaflet attachment, probably related to the higher level of procedure experience by individual operators [7]. Rudolph et al. reported clip detachment in 2 of 96 patients as a periprocedural complication that was remedied by placing an additional clip [8]. Recently, Maisano et al. published the one-year follow-up results of the ACCESS-EU prospective multicenter nonrandomized post-approval study that confirmed the efficacy of the procedure in high-risk elderly patients mainly affected by functional MR [9]. Single leaflet MC attachment was reported in 4.8% of cases despite no device embolization.
Braun et al. reported 4 cases of single leaflet device attachment in 47 patients undergoing two-dimensional TEE intraprocedural monitoring and none in 40 patients monitored with 3D TEE [10]. The authors stressed the value of the additional use of 3D acquisition to conventional biplane TEE approach to avoid the occurrence of this complication. Intraprocedural assessment of device attachment prior to clip release is crucial for achieving both a good immediate goal (i.e., reduced regurgitant volume) and durability of device anchoring. Partial MC detachment is usually due to asymmetric grasping or inadequate leaflet capture within the clip [11]. It is likely that in our case the use of conventional imaging did not allow us to assess clip anchoring adequately. As already emphasized by other authors, 3D TEE has the peculiar ability
R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
e115
Fig. 2. Real-time three-dimensional echocardiographic reconstruction of the mitral valve showing the cleft of the posterior mitral leaflet (see arrows) in systole (upper panel) and diastole (lower panel). AML = anterior mitral leaflet; and PML = posterior mitral leaflet.
to simultaneously display different sections in orthogonal planes (multiplane modality) before volume acquisition. This enables a more accurate assessment of the amount of valvular tissue for each leaflet secured within the clip arms and grippers, thus ensuring proper grasping and symmetric leaflet capture. It is also worth noting that the physiological changes in mitral annular geometry during the cardiac cycle result in a constant stretching and whip effect of the mitral leaflets captured between the clip arms leading to perforation [12]. As previously demonstrated, partial MC detachment is a rare but possible complication, especially during the first months as the physiological healing response to clip implantation occurs about 6 months after the procedure [13]. Given the likelihood of partial
detachment within the first few months after MC implantation, close echocardiographic follow-up should be recommended during hospitalization and after discharge. In addition, our case demonstrates that 3D TEE may also prove useful in the follow-up of patients who develop complications. Besides partial device detachment, 3D TEE documented the perforation of the mitral leaflet that came off the clip. Of note, this peculiar complication has never been reported previously. Clip detachment is usually repaired with the implant of a second clip (if detected intraprocedurally) or surgically. The detection of MC detachment and the assessment of the integrity of the MV apparatus in the early follow-up are of utmost importance in order to consider the possibility of removing a clip not yet covered
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R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
by a fibrous cap [13] and to plan surgical MV repair rather than replacement. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.ijcard.2013.12.040. References [1] Trichon BH, Felker GM, Shaw LK, Cabell CH, O'Connor CM. Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol 2003;91:538–43. [2] Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451–96. [3] Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 2007;28:1358–65. [4] Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 2005;46:2134–40. [5] Argenziano M, Skipper E, Heimansohn D, et al; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg 2010;89:72–80.
[6] Mauri L, Foster E, Glower DD, et al; EVEREST II Investigators. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013;62:317–28. [7] Kar S, Lim S, Feldman T. EVEREST II Realism: a continued access study to evaluate the safety and effectiveness of the MitraClip device: demographics and procedural outcomes. [abstract] Catheter Cardiovasc Interv 2011;77(Suppl. 6):146. [8] Rudolph V, Knap M, Franzen O, et al. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol 2011;58:2190–5. [9] Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 2013;62:1052–61. [10] Braun D, Orban M, Michalk F, et al. Three-dimensional transoesophageal echocardiography for the assessment of clip attachment to the leaflets in percutaneous edgeto-edge repair of the mitral valve. EuroIntervention 2013;8:1379–87. [11] Maisano F. The devil is in the details: further steps towards surgical standards with Mitral Clip management? EuroIntervention 2013;8:1349–51. [12] Nielsen SL, Timek TA, Lai DT, et al. Edge-to-edge mitral repair: tension on the approximating suture and leaflet deformation during acute ischemic mitral regurgitation in the ovine heart. Circulation 2001;104(12 Suppl. 1):I29–35. [13] Ladich E, Michaels MB, Jones RM, et al; EVEREST Investigators. Pathological healing response of explanted MitraClip devices. Circulation 2011;123:1418–27.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Partial clip detachment and posterior mitral leaflet perforation after mitraclip implantation Rodolfo Citro ⁎, Cesare Baldi, Generoso Mastrogiovanni, Angelo Silverio, Eduardo Bossone, Pietro Giudice, Federico Piscione, Giuseppe Di Benedetto Heart Department, University Hospital “San Giovanni di Dio e Ruggi d'Aragona”, Salerno, Italy
a r t i c l e
i n f o
Article history: Received 27 October 2013 Accepted 17 December 2013 Available online 27 December 2013 Keywords: Mitral regurgitation Mitraclip complications Three-dimensional echocardiography
Dear Editor, A 64-year-old woman with a history of essential hypertension, left ventricular systolic dysfunction, chronic obstructive pulmonary disease, and recurrent flash pulmonary edema despite adequate pharmacological therapy was admitted to our hospital for acute decompensated heart failure. Transthoracic echocardiography (TTE) showed a reduced left ventricular ejection fraction (36%), severe mitral regurgitation (MR) (effective regurgitant orifice area of 33 mm2 in mesosystole) and elevated pulmonary artery systolic pressure (55 mmHg). The patient was treated with high-dose intravenous furosemide and non-invasive ventilation. After improvement of her clinical condition, conventional two-dimensional transesophageal echocardiography (TEE) and coronary angiography were planned to establish the etiology of cardiomyopathy and MR, to localize the origin of the regurgitant jet and to assess mitral valve (MV) anatomy. TEE with midesophageal intercommissural (at 60°) and left ventricular outflow tract (at 120°) views revealed a central jet involving the A2-P2 scallops due to symmetric leaflet tethering. The vena contracta was estimated to be 7 mm, and no additional regurgitant jets were visualized. Several parameters that need to be measured for planning MitraClip (MC) (Abbott Vascular, Menlo Park, CA, USA) implantation were also calculated, including tenting area, coaptation depth (11 mm), coaptation length (3.1 mm) and the distance from the fossa ovalis to leaflet coaptation (48 mm). In addition, an estimate ⁎ Corresponding author at: University Hospital “San Giovanni di Dio e Ruggi d'Aragona”, Heart Tower room 810, Largo Città di Ippocrate, Salerno 84131, Italy. Tel.: + 39 089 673377; +39 3473570880(mobile). E-mail address: [email protected] (R. Citro). 0167-5273/$ – see front matter © 2013 Elsevier Ireland. Ltd All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.12.040
of MV area (5.27 cm2) was obtained from the transgastric view. No significant coronary stenosis was observed on coronary angiography. The patient was judged to have severe functional MR by the local “heart team”, including a clinical and interventional cardiologist, an echocardiographer and a cardiac surgeon, and was considered to be amenable to percutaneous treatment because of high surgical risk and patient's preference. After successful transseptal puncture, a MC device was implanted with standard technique under conventional TEE monitoring. The leaflets were grasped by the clip with residual moderate regurgitation. However, given the relatively high transmitral gradient (5.6 mmHg) and the risk for worsening stenosis, a second clip was not implanted. Two months later the patient was readmitted for fatigue and reduced effort tolerance with clinical signs of heart failure. TTE showed recurrence of severe MR due to single leaflet clip attachment to the anterior mitral leaflet (see movies 1 and 2). TEE confirmed partial clip detachment. Additionally, color flow mapping revealed a flow convergence area on the posterior mitral leaflet (Fig. 1), suggesting leaflet perforation that was confirmed by real-time three-dimensional (3D) acquisition (General ElectricVivid E9; GE Vingmed ultrasound —Horten, Norway. Fig. 2; see also movies 3 and 4). Surgical MV replacement was proposed but the patient refused. Moderate to severe MR is a common finding in patients with congestive heart failure, occurring approximately in one third of cases [1]. According to guideline criteria [2], MV surgery is considered the standard treatment for patients with severe MR. However, almost half of patients with heart failure and severe MR are at high risk and are denied surgery because of coexisting comorbidities, advanced left ventricular systolic dysfunction, or old age [3]. MC implantation has rapidly emerged as an alternative treatment option for patients with severe MR who are not amenable to MV surgery. The Endovascular Valve Edge-to-Edge Repair Study (EVEREST I) was the first clinical trial to enroll predominantly patients with degenerative MR, and demonstrated that MC implantation is safe and feasible, with a significant reduction in MR grade (b2 +) observed in 74% of cases [4]. At long-term follow-up, 90.1% of patients were free from death and 76.3% were free from MV surgery; clip detachment was reported in 9% of cases [4]. Of the 32 patients enrolled in the EVEREST II trial undergoing post-clip MV surgery, in 10 cases the indication was partial clip detachment detected procedurally, at discharge, at 30 days and 12 months of follow-up in 3, 1, 5 and 1 patients, respectively [5]. Surgical MV repair or replacement was required in 8 and 2 patients, respectively, but the overall rate of 5% in
e114
R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
Fig. 1. Upper panels: transesophageal echocardiography (orthogonal view) showing single leaflet attachment of the MitraClip on the anterior mitral leaflet (see dotted arrows). Lower panels: color flow mapping in the same section as the upper panels. A flow convergence area (see solid arrow) can be appreciated in correspondence of the perforation of the posterior mitral leaflet. AML = anterior mitral leaflet; LA = left atrium; and LV = left ventricle.
the EVEREST II trial represents early experience with the novel MC device [6]. Preliminary data from EVEREST II REALISM indicate an even lower rate of single leaflet attachment, probably related to the higher level of procedure experience by individual operators [7]. Rudolph et al. reported clip detachment in 2 of 96 patients as a periprocedural complication that was remedied by placing an additional clip [8]. Recently, Maisano et al. published the one-year follow-up results of the ACCESS-EU prospective multicenter nonrandomized post-approval study that confirmed the efficacy of the procedure in high-risk elderly patients mainly affected by functional MR [9]. Single leaflet MC attachment was reported in 4.8% of cases despite no device embolization.
Braun et al. reported 4 cases of single leaflet device attachment in 47 patients undergoing two-dimensional TEE intraprocedural monitoring and none in 40 patients monitored with 3D TEE [10]. The authors stressed the value of the additional use of 3D acquisition to conventional biplane TEE approach to avoid the occurrence of this complication. Intraprocedural assessment of device attachment prior to clip release is crucial for achieving both a good immediate goal (i.e., reduced regurgitant volume) and durability of device anchoring. Partial MC detachment is usually due to asymmetric grasping or inadequate leaflet capture within the clip [11]. It is likely that in our case the use of conventional imaging did not allow us to assess clip anchoring adequately. As already emphasized by other authors, 3D TEE has the peculiar ability
R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
e115
Fig. 2. Real-time three-dimensional echocardiographic reconstruction of the mitral valve showing the cleft of the posterior mitral leaflet (see arrows) in systole (upper panel) and diastole (lower panel). AML = anterior mitral leaflet; and PML = posterior mitral leaflet.
to simultaneously display different sections in orthogonal planes (multiplane modality) before volume acquisition. This enables a more accurate assessment of the amount of valvular tissue for each leaflet secured within the clip arms and grippers, thus ensuring proper grasping and symmetric leaflet capture. It is also worth noting that the physiological changes in mitral annular geometry during the cardiac cycle result in a constant stretching and whip effect of the mitral leaflets captured between the clip arms leading to perforation [12]. As previously demonstrated, partial MC detachment is a rare but possible complication, especially during the first months as the physiological healing response to clip implantation occurs about 6 months after the procedure [13]. Given the likelihood of partial
detachment within the first few months after MC implantation, close echocardiographic follow-up should be recommended during hospitalization and after discharge. In addition, our case demonstrates that 3D TEE may also prove useful in the follow-up of patients who develop complications. Besides partial device detachment, 3D TEE documented the perforation of the mitral leaflet that came off the clip. Of note, this peculiar complication has never been reported previously. Clip detachment is usually repaired with the implant of a second clip (if detected intraprocedurally) or surgically. The detection of MC detachment and the assessment of the integrity of the MV apparatus in the early follow-up are of utmost importance in order to consider the possibility of removing a clip not yet covered
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R. Citro et al. / International Journal of Cardiology 171 (2014) e113–e116
by a fibrous cap [13] and to plan surgical MV repair rather than replacement. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.ijcard.2013.12.040. References [1] Trichon BH, Felker GM, Shaw LK, Cabell CH, O'Connor CM. Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol 2003;91:538–43. [2] Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451–96. [3] Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 2007;28:1358–65. [4] Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 2005;46:2134–40. [5] Argenziano M, Skipper E, Heimansohn D, et al; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg 2010;89:72–80.
[6] Mauri L, Foster E, Glower DD, et al; EVEREST II Investigators. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013;62:317–28. [7] Kar S, Lim S, Feldman T. EVEREST II Realism: a continued access study to evaluate the safety and effectiveness of the MitraClip device: demographics and procedural outcomes. [abstract] Catheter Cardiovasc Interv 2011;77(Suppl. 6):146. [8] Rudolph V, Knap M, Franzen O, et al. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol 2011;58:2190–5. [9] Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 2013;62:1052–61. [10] Braun D, Orban M, Michalk F, et al. Three-dimensional transoesophageal echocardiography for the assessment of clip attachment to the leaflets in percutaneous edgeto-edge repair of the mitral valve. EuroIntervention 2013;8:1379–87. [11] Maisano F. The devil is in the details: further steps towards surgical standards with Mitral Clip management? EuroIntervention 2013;8:1349–51. [12] Nielsen SL, Timek TA, Lai DT, et al. Edge-to-edge mitral repair: tension on the approximating suture and leaflet deformation during acute ischemic mitral regurgitation in the ovine heart. Circulation 2001;104(12 Suppl. 1):I29–35. [13] Ladich E, Michaels MB, Jones RM, et al; EVEREST Investigators. Pathological healing response of explanted MitraClip devices. Circulation 2011;123:1418–27.
