Martin Haensig, MD, David Michael Holzhey, MD, PhD, Michael Andrew Borger, MD, PhD, Axel Linke, MD, PhD, Joerg Seeburger, MD, PhD, Sven Lehmann, MD, PhD, Gerhard Schuler, MD, PhD, and Friedrich-Wilhelm Mohr, MD, PhD Department of Cardiac Surgery and Department of Cardiology, Heart Center of the University of Leipzig, Leipzig, Germany
Background. Concomitant mitral regurgitation (MR) is frequently present before the performance of transapical aortic valve implantation (TA-AVI). Our aim was to study the impact of MR on outcome and the effect of TA-AVI on MR using the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA). Methods. A total of 439 patients aged 81.5 ± 6.4 years, 64.0% of whom were women, underwent TA-AVI between February 2006 and August 2011. The mean logistic EuroSCORE was 29.7% ± 15.7% and the mean Society of Thoracic Surgeons (STS) score was 11.4% ± 7.6%. Outcome was assessed in patients with absent (9.8%), mild or trivial (58.5%), moderate (29.7%), and severe (2.0%) MR by pre- and postoperative echocardiography. Results. Patients with moderate/severe MR versus mild or trivial MR had an increased in-hospital mortality (adjusted hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.79-8.84; p [ 0.001) but a comparable 4-year survival (adjusted HR, 1.29; 95% CI, 0.47-3.49;
p [ 0.623). During postoperative echocardiographic examination, there was an overall improvement in mitral incompetence (absent in 23.6%, mild in 58.6%, moderate in 17.8%, and severe in none). Independent multivariate variables associated with improved MR were MR greater than 1D (odds ratio [OR], 7.73; p < 0.001), the presence of functional MR (OR, 3.66; p [ 0.011), left ventricular ejection fraction (LVEF) of 60% or more (OR, 3.28; p [ 0.002), and a mean transaortic gradient (OR, 1.03; p [ 0.005). Conclusions. Moderate/severe MR before TA-AVI is associated with an increased early, but a comparable late, mortality. We observed an overall improved mitral valve performance, possibly resulting from reducing both subvalvular traction and closure forces acting on the mitral valve.
C
impact on outcome. Changes in ventricular function may be reversible, and significant MR may improve after TA-AVI alone [2]. The issue of how to address MR during TA-AVI currently remains uncertain, because only limited data are available to support clinical decision making [3]. Thus, the aim of this study was to investigate the impact of MR on outcome and the effect of TA-AVI on MR using the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA).
oncomitant mitral regurgitation (MR) is frequently present before the performance of transapical aortic valve implantation (TA-AVI). Compared with patients undergoing conventional aortic valve replacement (AVR), candidates for transcatheter-based interventions often present with older age, additional comorbidities, and severe valvular calcification [1]. The risk of problems with severe MR postoperatively needs to be considered if leaving concomitant MR unrepaired. The heart team therefore must often decide which operation to recommend [2]. It is therefore important to distinguish whether MR is likely secondary to aortic stenosis or left ventricular (LV) dysfunction or caused by structural abnormalities of the mitral valve. The relief of aortic stenosis lowers LV systolic pressure [2]. Furthermore, postprocedural reverse remodeling observed after TA-AVI may have a further Accepted for publication Nov 11, 2013. Presented at the Forty-ninth Annual Meeting of The Society of Thoracic Surgeons, Los Angeles, CA, Jan 26–30, 2013. Address correspondence to Dr Haensig, Department of Cardiac Surgery, Heart Center of the University Leipzig, Struempellstr. 39, 04289 Leipzig, Germany; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:1247–54) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods Study Design All patients undergoing TA-AVI with an Edwards SAPIEN valve at the Leipzig Heart Center between February 2006 and August 2011 (n ¼ 439) were analyzed. Data was drawn from a prospective database and analyzed retrospectively. Mean age was 81.5 6.4 years and mean Society of Thoracic Surgeons (STS) score was 11.4% 7.6%. Overall, 64.0% of participants were women. Preoperative characteristics of the patients are presented in Table 1. 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2013.11.025
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Ann Thorac Surg 2014;97:1247–54
Table 1. Baseline Characteristics of Patients With Mild, Moderate, or Severe MR Patients ADULT CARDIAC
Mild or Trivial MR (n ¼ 300)
Moderate MR (n ¼ 130)
Severe MR (n ¼ 9)
p Value
81.0 6.6 191 63.7 163.7 8.6 1.80 0.21 255 (85.0%) 0.6 0.2 133 (44.3) 45 (15.0) 56.9 12.9 49 (16.3) 169 (56.3) 52 (17.3) 22 (7.3) 36 (12.0) 99 (33.0) 44 (14.7) 130 (43.3) 30 (10.0) 91.5 34.2 28.1 15.0 10.5 7.0
82.3 5.9 84 65.6 162.4 8.7 1.75 0.19 105 (82.0%) 0.6 0.2 56 (43.8) 27 (20.8) 51.4 13.6 29 (22.7) 74 (57.8) 18 (14.1) 10 (7.7) 18 (13.8) 54 (41.5) 21 (16.4) 57 (44.5) 14 (10.9) 92.9 31.0 34.4 17.7 13.6 8.7
82.0 4.8 5 55.6 162.0 13.4 1.70 0.18 9 (100.0%) 0.6 0.3 6 (66.7) 3 (33.3) 52.3 14.8 1 (11.1) 5 (55.6) 3 (33.3) 1 (11.1) 2 (22.2) 6 (66.7) 4 (44.4) 2 (22.2) 1 (11.1) 74.0 23.4 33.3 10.6 15.2 14.0
0.04 0.83 0.37 0.21 0.31 0.21 0.45 0.14 60 mm Hg, n (%) Porcelain aorta, n (%) Atrial enlargement, n (%) (f > 52 mL, m > 58 mL) Atrial fibrillation, n (%) Diabetes, n (%) Chronic renal insufficiency, creatinine > 2 mg/dL, n (%) FEV1, % of normal Logistic EuroSCORE, % STS score, %
EuroSCORE ¼ European System for Cardiac Operative Risk Evaluation; f ¼ female; male; NYHA ¼ New York Heart Association; STS ¼ Society of Thoracic Surgeons.
Primary end points were the prevalence of concomitant MR and changes over time in MR severity. The secondary end points were postprocedural outcome and survival, as well as independent variables associated with improved MR. Clinical inclusion criteria were age older than 75 years, New York Heart Association (NYHA) functional class II or higher, written informed consent, and comorbidities leading to a logistic EuroSCORE of 15% or higher. By standard protocol, all patients underwent transthoracic and transesophageal echocardiography. Echocardiographic inclusion criteria were severe degenerative aortic valve stenosis indicated by an aortic valve area 1.0 cm2 or less or a jet velocity greater than 4 m/s or a mean gradient greater than 40 mm Hg, or a combination of these factors. Every patient underwent transesophageal and transthoracic echocardiography by an experienced echocardiographer before the procedure and before discharge, as well as at yearly intervals according to the guidelines of the American Society of Echocardiography [4]. MR severity was graded as none or trivial, mild, moderate, or severe according to the American College of Cardiology, the American Heart Association, and the European Society of Cardiology recommendations and classified as predominantly functional or structural MR according to its etiology lesion as well as the dysfunction [5]. LV ejection fraction (LVEF) was calculated using the biplane Simpson’s method. Pulmonary hypertension was defined as a pulmonary artery systolic pressure greater than 60 mm Hg, as estimated by Doppler echocardiography or
FEV1 ¼ forced expiratory volume in 1 second;
m ¼
measured by cardiac catheterization [6]. Porcelain aorta was defined as an extensive circumferential calcification of the thoracic aorta, as assessed by computed tomography or fluoroscopy, or both [6].
Transcatheter Aortic Valve All treatment options, including conventional surgical procedures, were discussed in an interdisciplinary heart team conference. All patients received the Edwards SAPIEN Transcatheter Heart Valve or SAPIEN XT (Edwards Lifesciences) composed of a pericardial xenograft fixed within a stainless steel or cobalt chrome balloon-expandable stent (Table 1). Patients with an aortic annulus diameter of 19 to 22 mm received a 23-mm Edwards SAPIEN, and patients with an aortic annulus diameter between 22 and 24 mm received a 26-mm prosthesis. The 29-mm Edwards SAPIEN has been officially available since January 2011 and was used for patients with an aortic annulus diameter between 24 and 27 mm.
Implantation Technique All procedures were performed using general anesthesia in a fully equipped hybrid operating room. Before skin incision, a femoral “safety net” was established with a venous guidewire and a 6F arterial sheath to ensure femoral access in case of emergency cannulation for cardiopulmonary bypass. TA-AVI was performed as previously described in detail [7].
HAENSIG ET AL IMPROVED MITRAL VALVE PERFORMANCE AFTER TAAVI
Statistical Analysis
(absent in 23.6%, mild in 58.6%, moderate in 17.8%, and severe in none) (Fig 1). Postoperative echocardiographic follow-up was complete in 382 patients (87%). Moderate MR improved in 79 patients (60.8%), remained moderate in 51 patients (39.2%), and worsened to severe in none. At 1 year, moderate MR had improved in 52.3% of patients, remained moderate in 18.5% of patients, and worsened to severe in 2.3% of patients; 26.9% of patients had died. In patients with severe MR at baseline, MR improved in 77.8% of patients and remained severe in none. At 1 year, preoperative severe MR had improved in 22.2% of patients and was severe in 33.3% of patients; 44.5% of patients had died. With regard to NYHA functional class, at 4-year followup patients had generally improved, with only 29.2% of patients in class III and 8.3% of patients in class IV (Fig 2).
All statistical analyses were performed using SPSS, version 16.0 (SPSS, Inc, Chicago, IL). Continuous variables are expressed as mean standard deviation for nearly Gaussian distributed variables and otherwise median values (interquartile range). Categorical data are given as proportions. Continuous variables were analyzed by a 2-tailed Student’s t test or by a MannWhitney U test for nonnormally distributed variables. Univariate and stepwise multivariate logistic regression analysis of variables associated with improved MR were examined (stepwise forward procedure). Those variables that had a probability value of less than or equal to 0.05 by univariate analysis were included in the multivariate model, and corresponding ORs and 95% CIs were determined. Long-term survival was depicted by KaplanMeier curves. To adjust for possible confounders, factors disbalanced between the groups were included as covariables into a multivariate Cox regression model. A p value of less than 0.05 was considered statistically significant.
Results A total of 439 patients were analyzed. Valves implanted were the Cribier-Edwards in 134 (30.5%) patients, the Edwards SAPIEN in 189 (43.1%) patients, and the SAPIEN XT in 116 (26.4%) patients. At baseline, MR was absent in 43 patients (9.8%), mild or trivial in 257 (58.5%) patients, moderate in 130 (29.7%) patients, and severe in 9 (2.0%) patients. As shown in Table 1, moderate or severe MR was associated with increasing age, lower LVEF, atrial enlargement, atrial fibrillation, and a higher STS risk score.
Changes Over Time in MR Severity During postoperative echocardiographic examination, there was an overall improvement in mitral incompetence
Procedural Outcome and Survival MR was an important risk factor of peri- and postoperative outcome, as shown in a higher rate of conversion to open aortic valve replacement (AVR), valve-in-valve implantation, as well as less off-pump procedures (Table 2). Mortality in patients with mild or trivial, moderate, and severe MR at baseline was 7.7%, 13.1%, and 22.2% at 30 days, respectively. Patients with moderate/severe MR versus mild or trivial MR had an increased in-hospital mortality (adjusted HR, 3.98; 95% CI, 1.79-8.84; p ¼ 0.001) but a comparable 4-year survival (adjusted HR, 1.29; 95% CI, 0.47-3.49; p ¼ 0.623) (Fig 3).
Variables Associated With Improved MR Univariate analysis also revealed a trend toward prediction of improved MR for patients with a central regurgitation jet of the mitral valve (OR, 4.52; p ¼ 0.001), aortic stenosis as the cause of MR (OR, 2.95; p < 0.001), Carpentier type IIIb class (OR, 1.92; p ¼ 0.004), and a LV posterior wall dimension of 16 mm or larger (OR, 1.85; p ¼ 0.015). Fig 1. Degree of mitral regurgitation (MR) after transapical aortic valve implantation (TA-AVI) and follow-up in patients with MR at baseline.
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Fig 2. New York Heart Association (NYHA) functional class at baseline and follow-up in patients with mitral regurgitation (MR) after transapical aortic valve implantation (TA-AVI). ADULT CARDIAC
Of all preoperative and intraoperative factors analyzed, only MR greater than 1þ (OR, 7.73; p < 0.001), the presence of functional MR (OR, 3.66; p ¼ 0.011), LVEF of 60% or greater (OR, 3.28; p ¼ 0.002), and a mean transaortic gradient (OR, 1.03; p ¼ 0.005) could be identified as independent variables associated with improved MR by stepwise multivariate regression (Table 3). In contrast, concomitant atrial enlargement and atrial fibrillation failed to predict improved MR.
Comment Transcatheter aortic valve implantation has become a standard of care for high-risk patients with severe aortic stenosis [8, 9]. Significant improvements in 1-year
survival and quality of life have been reported [10]. Recent technical refinements, including reduced sheath sizes and novel second-generation devices, have resulted in acceptable short- and mid-term results [11, 12]. The data presented herein confirm an overall improved mitral valve performance after TA-AVI. With regard to the impact of MR on outcomes after TA-AVI, 30-day mortality was significantly increased in patients with severe MR in the Canadian registry (16.8% versus 7.0%; p ¼ 0.049) [6]. The Italian CoreValve Registry reported that severe MR was present in 13.2% of patients who died at follow-up but in only 4.9% of those who survived [13]. Our data herein once again confirm that concomitant MR of more than 1þ was an important risk factor of peri- and postoperative outcome in TA-AVI [2].
Table 2. Perioperative Data Patients Off-pump procedure, n (%) Procedural time, min Valve implantation, Edwards SAPIEN 23 mm, n (%) 26 mm, n (%) 29 mm, n (%) Mean aortic gradient, mm Hg Aortic valve orifice area, cm2 Conversion to open AVR, n (%) Implantation of a second Edwards SAPIEN, n (%) Coronary intervention, n (%) Disabling stroke (mRS score 2 at 90 d)a, n (%) New pacemaker implantation, n (%) a
Mild or Trivial MR (n ¼ 300) 288 (96.0) 85.8 42.6
According to the Valve Academic Research Consortium-2 guidelines.
mRS ¼ modified Rankin scale.
85 (28.3) 202 (67.3) 13 (4.3) 6.8 4.1 1.3 0.6 5 (1.7) 15 (5.0) 9 (3.0) 6 (1.7) 36 (12.0)
Moderate MR (n ¼ 130)
Severe MR (n ¼ 9)
p Value
111 (85.4) 92.0 47.0
7 (77.8) 115.0 80.4
1þ Functional MR LVEF 60% P meanaortic LVPWd 16 mm Central jet Carpentier type IIIb Aortic stenosis cause of MR
OR (95% CI) 6.81 3.18 1.50 1.02 1.85 4.52 1.92 2.95
(3.95-11.74) (2.01-5.05) (0.95-2.35) (1.01-1.03) (1.13-3.04) (1.88-10.85) (1.23-3.00) (1.80-4.83)
Multivariate p Value
Background. Concomitant mitral regurgitation (MR) is frequently present before the performance of transapical aortic valve implantation (TA-AVI). Our aim was to study the impact of MR on outcome and the effect of TA-AVI on MR using the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA). Methods. A total of 439 patients aged 81.5 ± 6.4 years, 64.0% of whom were women, underwent TA-AVI between February 2006 and August 2011. The mean logistic EuroSCORE was 29.7% ± 15.7% and the mean Society of Thoracic Surgeons (STS) score was 11.4% ± 7.6%. Outcome was assessed in patients with absent (9.8%), mild or trivial (58.5%), moderate (29.7%), and severe (2.0%) MR by pre- and postoperative echocardiography. Results. Patients with moderate/severe MR versus mild or trivial MR had an increased in-hospital mortality (adjusted hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.79-8.84; p [ 0.001) but a comparable 4-year survival (adjusted HR, 1.29; 95% CI, 0.47-3.49;
p [ 0.623). During postoperative echocardiographic examination, there was an overall improvement in mitral incompetence (absent in 23.6%, mild in 58.6%, moderate in 17.8%, and severe in none). Independent multivariate variables associated with improved MR were MR greater than 1D (odds ratio [OR], 7.73; p < 0.001), the presence of functional MR (OR, 3.66; p [ 0.011), left ventricular ejection fraction (LVEF) of 60% or more (OR, 3.28; p [ 0.002), and a mean transaortic gradient (OR, 1.03; p [ 0.005). Conclusions. Moderate/severe MR before TA-AVI is associated with an increased early, but a comparable late, mortality. We observed an overall improved mitral valve performance, possibly resulting from reducing both subvalvular traction and closure forces acting on the mitral valve.
C
impact on outcome. Changes in ventricular function may be reversible, and significant MR may improve after TA-AVI alone [2]. The issue of how to address MR during TA-AVI currently remains uncertain, because only limited data are available to support clinical decision making [3]. Thus, the aim of this study was to investigate the impact of MR on outcome and the effect of TA-AVI on MR using the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA).
oncomitant mitral regurgitation (MR) is frequently present before the performance of transapical aortic valve implantation (TA-AVI). Compared with patients undergoing conventional aortic valve replacement (AVR), candidates for transcatheter-based interventions often present with older age, additional comorbidities, and severe valvular calcification [1]. The risk of problems with severe MR postoperatively needs to be considered if leaving concomitant MR unrepaired. The heart team therefore must often decide which operation to recommend [2]. It is therefore important to distinguish whether MR is likely secondary to aortic stenosis or left ventricular (LV) dysfunction or caused by structural abnormalities of the mitral valve. The relief of aortic stenosis lowers LV systolic pressure [2]. Furthermore, postprocedural reverse remodeling observed after TA-AVI may have a further Accepted for publication Nov 11, 2013. Presented at the Forty-ninth Annual Meeting of The Society of Thoracic Surgeons, Los Angeles, CA, Jan 26–30, 2013. Address correspondence to Dr Haensig, Department of Cardiac Surgery, Heart Center of the University Leipzig, Struempellstr. 39, 04289 Leipzig, Germany; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:1247–54) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods Study Design All patients undergoing TA-AVI with an Edwards SAPIEN valve at the Leipzig Heart Center between February 2006 and August 2011 (n ¼ 439) were analyzed. Data was drawn from a prospective database and analyzed retrospectively. Mean age was 81.5 6.4 years and mean Society of Thoracic Surgeons (STS) score was 11.4% 7.6%. Overall, 64.0% of participants were women. Preoperative characteristics of the patients are presented in Table 1. 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2013.11.025
ADULT CARDIAC
Improved Mitral Valve Performance After Transapical Aortic Valve Implantation
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HAENSIG ET AL IMPROVED MITRAL VALVE PERFORMANCE AFTER TAAVI
Ann Thorac Surg 2014;97:1247–54
Table 1. Baseline Characteristics of Patients With Mild, Moderate, or Severe MR Patients ADULT CARDIAC
Mild or Trivial MR (n ¼ 300)
Moderate MR (n ¼ 130)
Severe MR (n ¼ 9)
p Value
81.0 6.6 191 63.7 163.7 8.6 1.80 0.21 255 (85.0%) 0.6 0.2 133 (44.3) 45 (15.0) 56.9 12.9 49 (16.3) 169 (56.3) 52 (17.3) 22 (7.3) 36 (12.0) 99 (33.0) 44 (14.7) 130 (43.3) 30 (10.0) 91.5 34.2 28.1 15.0 10.5 7.0
82.3 5.9 84 65.6 162.4 8.7 1.75 0.19 105 (82.0%) 0.6 0.2 56 (43.8) 27 (20.8) 51.4 13.6 29 (22.7) 74 (57.8) 18 (14.1) 10 (7.7) 18 (13.8) 54 (41.5) 21 (16.4) 57 (44.5) 14 (10.9) 92.9 31.0 34.4 17.7 13.6 8.7
82.0 4.8 5 55.6 162.0 13.4 1.70 0.18 9 (100.0%) 0.6 0.3 6 (66.7) 3 (33.3) 52.3 14.8 1 (11.1) 5 (55.6) 3 (33.3) 1 (11.1) 2 (22.2) 6 (66.7) 4 (44.4) 2 (22.2) 1 (11.1) 74.0 23.4 33.3 10.6 15.2 14.0
0.04 0.83 0.37 0.21 0.31 0.21 0.45 0.14 60 mm Hg, n (%) Porcelain aorta, n (%) Atrial enlargement, n (%) (f > 52 mL, m > 58 mL) Atrial fibrillation, n (%) Diabetes, n (%) Chronic renal insufficiency, creatinine > 2 mg/dL, n (%) FEV1, % of normal Logistic EuroSCORE, % STS score, %
EuroSCORE ¼ European System for Cardiac Operative Risk Evaluation; f ¼ female; male; NYHA ¼ New York Heart Association; STS ¼ Society of Thoracic Surgeons.
Primary end points were the prevalence of concomitant MR and changes over time in MR severity. The secondary end points were postprocedural outcome and survival, as well as independent variables associated with improved MR. Clinical inclusion criteria were age older than 75 years, New York Heart Association (NYHA) functional class II or higher, written informed consent, and comorbidities leading to a logistic EuroSCORE of 15% or higher. By standard protocol, all patients underwent transthoracic and transesophageal echocardiography. Echocardiographic inclusion criteria were severe degenerative aortic valve stenosis indicated by an aortic valve area 1.0 cm2 or less or a jet velocity greater than 4 m/s or a mean gradient greater than 40 mm Hg, or a combination of these factors. Every patient underwent transesophageal and transthoracic echocardiography by an experienced echocardiographer before the procedure and before discharge, as well as at yearly intervals according to the guidelines of the American Society of Echocardiography [4]. MR severity was graded as none or trivial, mild, moderate, or severe according to the American College of Cardiology, the American Heart Association, and the European Society of Cardiology recommendations and classified as predominantly functional or structural MR according to its etiology lesion as well as the dysfunction [5]. LV ejection fraction (LVEF) was calculated using the biplane Simpson’s method. Pulmonary hypertension was defined as a pulmonary artery systolic pressure greater than 60 mm Hg, as estimated by Doppler echocardiography or
FEV1 ¼ forced expiratory volume in 1 second;
m ¼
measured by cardiac catheterization [6]. Porcelain aorta was defined as an extensive circumferential calcification of the thoracic aorta, as assessed by computed tomography or fluoroscopy, or both [6].
Transcatheter Aortic Valve All treatment options, including conventional surgical procedures, were discussed in an interdisciplinary heart team conference. All patients received the Edwards SAPIEN Transcatheter Heart Valve or SAPIEN XT (Edwards Lifesciences) composed of a pericardial xenograft fixed within a stainless steel or cobalt chrome balloon-expandable stent (Table 1). Patients with an aortic annulus diameter of 19 to 22 mm received a 23-mm Edwards SAPIEN, and patients with an aortic annulus diameter between 22 and 24 mm received a 26-mm prosthesis. The 29-mm Edwards SAPIEN has been officially available since January 2011 and was used for patients with an aortic annulus diameter between 24 and 27 mm.
Implantation Technique All procedures were performed using general anesthesia in a fully equipped hybrid operating room. Before skin incision, a femoral “safety net” was established with a venous guidewire and a 6F arterial sheath to ensure femoral access in case of emergency cannulation for cardiopulmonary bypass. TA-AVI was performed as previously described in detail [7].
HAENSIG ET AL IMPROVED MITRAL VALVE PERFORMANCE AFTER TAAVI
Statistical Analysis
(absent in 23.6%, mild in 58.6%, moderate in 17.8%, and severe in none) (Fig 1). Postoperative echocardiographic follow-up was complete in 382 patients (87%). Moderate MR improved in 79 patients (60.8%), remained moderate in 51 patients (39.2%), and worsened to severe in none. At 1 year, moderate MR had improved in 52.3% of patients, remained moderate in 18.5% of patients, and worsened to severe in 2.3% of patients; 26.9% of patients had died. In patients with severe MR at baseline, MR improved in 77.8% of patients and remained severe in none. At 1 year, preoperative severe MR had improved in 22.2% of patients and was severe in 33.3% of patients; 44.5% of patients had died. With regard to NYHA functional class, at 4-year followup patients had generally improved, with only 29.2% of patients in class III and 8.3% of patients in class IV (Fig 2).
All statistical analyses were performed using SPSS, version 16.0 (SPSS, Inc, Chicago, IL). Continuous variables are expressed as mean standard deviation for nearly Gaussian distributed variables and otherwise median values (interquartile range). Categorical data are given as proportions. Continuous variables were analyzed by a 2-tailed Student’s t test or by a MannWhitney U test for nonnormally distributed variables. Univariate and stepwise multivariate logistic regression analysis of variables associated with improved MR were examined (stepwise forward procedure). Those variables that had a probability value of less than or equal to 0.05 by univariate analysis were included in the multivariate model, and corresponding ORs and 95% CIs were determined. Long-term survival was depicted by KaplanMeier curves. To adjust for possible confounders, factors disbalanced between the groups were included as covariables into a multivariate Cox regression model. A p value of less than 0.05 was considered statistically significant.
Results A total of 439 patients were analyzed. Valves implanted were the Cribier-Edwards in 134 (30.5%) patients, the Edwards SAPIEN in 189 (43.1%) patients, and the SAPIEN XT in 116 (26.4%) patients. At baseline, MR was absent in 43 patients (9.8%), mild or trivial in 257 (58.5%) patients, moderate in 130 (29.7%) patients, and severe in 9 (2.0%) patients. As shown in Table 1, moderate or severe MR was associated with increasing age, lower LVEF, atrial enlargement, atrial fibrillation, and a higher STS risk score.
Changes Over Time in MR Severity During postoperative echocardiographic examination, there was an overall improvement in mitral incompetence
Procedural Outcome and Survival MR was an important risk factor of peri- and postoperative outcome, as shown in a higher rate of conversion to open aortic valve replacement (AVR), valve-in-valve implantation, as well as less off-pump procedures (Table 2). Mortality in patients with mild or trivial, moderate, and severe MR at baseline was 7.7%, 13.1%, and 22.2% at 30 days, respectively. Patients with moderate/severe MR versus mild or trivial MR had an increased in-hospital mortality (adjusted HR, 3.98; 95% CI, 1.79-8.84; p ¼ 0.001) but a comparable 4-year survival (adjusted HR, 1.29; 95% CI, 0.47-3.49; p ¼ 0.623) (Fig 3).
Variables Associated With Improved MR Univariate analysis also revealed a trend toward prediction of improved MR for patients with a central regurgitation jet of the mitral valve (OR, 4.52; p ¼ 0.001), aortic stenosis as the cause of MR (OR, 2.95; p < 0.001), Carpentier type IIIb class (OR, 1.92; p ¼ 0.004), and a LV posterior wall dimension of 16 mm or larger (OR, 1.85; p ¼ 0.015). Fig 1. Degree of mitral regurgitation (MR) after transapical aortic valve implantation (TA-AVI) and follow-up in patients with MR at baseline.
ADULT CARDIAC
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HAENSIG ET AL IMPROVED MITRAL VALVE PERFORMANCE AFTER TAAVI
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Fig 2. New York Heart Association (NYHA) functional class at baseline and follow-up in patients with mitral regurgitation (MR) after transapical aortic valve implantation (TA-AVI). ADULT CARDIAC
Of all preoperative and intraoperative factors analyzed, only MR greater than 1þ (OR, 7.73; p < 0.001), the presence of functional MR (OR, 3.66; p ¼ 0.011), LVEF of 60% or greater (OR, 3.28; p ¼ 0.002), and a mean transaortic gradient (OR, 1.03; p ¼ 0.005) could be identified as independent variables associated with improved MR by stepwise multivariate regression (Table 3). In contrast, concomitant atrial enlargement and atrial fibrillation failed to predict improved MR.
Comment Transcatheter aortic valve implantation has become a standard of care for high-risk patients with severe aortic stenosis [8, 9]. Significant improvements in 1-year
survival and quality of life have been reported [10]. Recent technical refinements, including reduced sheath sizes and novel second-generation devices, have resulted in acceptable short- and mid-term results [11, 12]. The data presented herein confirm an overall improved mitral valve performance after TA-AVI. With regard to the impact of MR on outcomes after TA-AVI, 30-day mortality was significantly increased in patients with severe MR in the Canadian registry (16.8% versus 7.0%; p ¼ 0.049) [6]. The Italian CoreValve Registry reported that severe MR was present in 13.2% of patients who died at follow-up but in only 4.9% of those who survived [13]. Our data herein once again confirm that concomitant MR of more than 1þ was an important risk factor of peri- and postoperative outcome in TA-AVI [2].
Table 2. Perioperative Data Patients Off-pump procedure, n (%) Procedural time, min Valve implantation, Edwards SAPIEN 23 mm, n (%) 26 mm, n (%) 29 mm, n (%) Mean aortic gradient, mm Hg Aortic valve orifice area, cm2 Conversion to open AVR, n (%) Implantation of a second Edwards SAPIEN, n (%) Coronary intervention, n (%) Disabling stroke (mRS score 2 at 90 d)a, n (%) New pacemaker implantation, n (%) a
Mild or Trivial MR (n ¼ 300) 288 (96.0) 85.8 42.6
According to the Valve Academic Research Consortium-2 guidelines.
mRS ¼ modified Rankin scale.
85 (28.3) 202 (67.3) 13 (4.3) 6.8 4.1 1.3 0.6 5 (1.7) 15 (5.0) 9 (3.0) 6 (1.7) 36 (12.0)
Moderate MR (n ¼ 130)
Severe MR (n ¼ 9)
p Value
111 (85.4) 92.0 47.0
7 (77.8) 115.0 80.4
1þ Functional MR LVEF 60% P meanaortic LVPWd 16 mm Central jet Carpentier type IIIb Aortic stenosis cause of MR
OR (95% CI) 6.81 3.18 1.50 1.02 1.85 4.52 1.92 2.95
(3.95-11.74) (2.01-5.05) (0.95-2.35) (1.01-1.03) (1.13-3.04) (1.88-10.85) (1.23-3.00) (1.80-4.83)
Multivariate p Value
