Jacques Métras

Patient-prosthesis mismatch can be predicted at the time of operation

BACKGROUND Patient-prosthesis mismatch is a frequent cause of high postoperative gradients in normally functioning prostheses. The objective of this study was to determine whether mismatch can be predicted at the time of operation. METHODS Indices used to predict mismatch were valve size, indexed internal geometric area, and projected indexed effective orifice area (EOA) calculated at the time of operation, and results were compared with indexed EOA and mean gradients measured by Doppler echocardiography after operation in 396 patients. RESULTS The sensitivity and specificity of these indices to detect mismatch, defined as a postoperative indexed EOA of 0.85 cm2/m2 or less, were respectively: 35% and 84% for valve size, 46% and 85% for indexed internal geometric area, and 73% and 80% for projected indexed EOA. Projected indexed EOA also correlated best with resting (r = 0.67) and exercise (r = 0.77) postoperative gradients. CONCLUSIONS The projected indexed EOA calculated at the time of operation accurately predicts mismatch as well as resting and exercise postoperative gradients, whereas valve size and indexed internal geometric area cannot be used for this purpose.

Long-term impact of diabetes and its comorbidities in patients undergoing isolated primary coronary artery bypass graft surgery.

Background— The objective of this study was to identify the impact of diabetes and related comorbidities, namely chronic renal failure, peripheral vascular disease, and low ejection fraction (<35%), on long-term survival of patients undergoing coronary artery bypass graft surgery. Methods and Results— A unicenter study was conducted on 9125 survivors of isolated coronary artery bypass graft surgery between 1992 and 2002. There were 6581 nondiabetic patients and 2544 diabetics, including 1809 patients with noninsulin-dependent diabetes mellitus and 735 patients with insulin-dependent diabetes mellitus. Cardiac-specific survival at 5 and 10 years was lower in insulin-dependent diabetes mellitus compared with both nondiabetic mellitus patients and patients with noninsulin-dependent diabetes mellitus (P<0.0001). However, freedom from cardiac-related death was similar for patients with noninsulin-dependent diabetes mellitus and nondiabetes mellitus patients up to 6 years (P=0 0.08) after surgery and was significantly lower thereafter (P=0.004). Cardiac-specific survival after coronary artery bypass graft surgery in patients with one or more comorbidities was comparable (P=0.4) for both nondiabetes mellitus patients and patients with noninsulin-dependent diabetes mellitus, but was significantly lower for those requiring insulin therapy (P<0.0001). Noninsulin-dependent diabetes mellitus was not an independent predictor of long-term cardiac death (hazard ratio: 1.09, P=0.41); however, insulin-dependent diabetes mellitus, chronic renal failure, peripheral vascular disease, and low ejection fraction were all independent risk factors for late cardiac death (all P<0.0001). The impact of comorbidities on the long-term risk of cardiac death was similar for the 3 groups. Conclusions— Noninsulin-dependent diabetes is not an independent predictor of late cardiac death after coronary artery bypass graft surgery, because cardiac-related survival is similar to that of nondiabetic patients for 6 years after surgery. In diabetic and nondiabetic patients, cardiac survival is adversely affected by the need for insulin therapy and/or the presence and number of comorbidities such as chronic renal failure, peripheral vascular disease, and low ejection fraction.

Permanent pacemaker implantation following isolated aortic valve replacement in a large cohort of elderly patients with severe aortic stenosis

Objectives To assess the incidence of conduction disturbances leading to permanent pacemaker implantation (PPI) following isolated aortic valve replacement (AVR) in a large cohort of elderly patients with severe symptomatic aortic stenosis, and to determine the predictive factors and prognostic value of PPI following AVR in such patients. Methods A total of 780 consecutive elderly patients (age 77±4 years, logistic EuroSCORE 10.4±8.5%, STS score 3.5±1.5%) with severe aortic stenosis and no previous pacemaker were analysed. Main outcome measures The incidence, clinical indications, timing and predictive factors of PPI within 30 days after AVR and their prognostic value were evaluated. Results Baseline ECG showed the presence of conduction abnormalities in 37.1% of the patients. Twenty-five patients (3.2%) needed PPI during the index hospitalisation due to the occurrence of complete atrioventricular block (2.6%) or severe bradycardia (0.6%). The presence of preprocedural left bundle branch block (OR 4.65, 95% CI 1.62 to 13.36, p=0.004) or right bundle branch block (OR 4.21, 95% CI 1.47 to 12.03, p=0.007) predicted the need for PPI after AVR. The need for PPI was associated with a longer hospital stay (p<0.0001). Thirty-day mortality rates were similar between patients with and without PPI (4% vs 3.2%, p=0.56). Survival rate at 5-year follow-up was 75%, with no differences between patients with and without PPI (p=0.12). Conclusions The need for PPI following isolated AVR in elderly patients with severe symptomatic aortic stenosis was low. Pre-existing bundle branch block predicted the need for PPI. PPI determined a longer hospital stay, but had no effect on acute and long-term mortality.

Does moderate mitral regurgitation impact early or mid-term clinical outcome in patients undergoing isolated aortic valve replacement for aortic stenosis?

OBJECTIVE The early and mid-term impact of functional mitral regurgitation (MR) in patients undergoing isolated aortic valve replacement (AVR) for aortic stenosis remains unresolved. METHOD Through our institutional databank, using a case-match study, we identified 58 patients with MR grades 0-1 and 58 patients with MR grades 2-3 (patients matched for sex, age, ejection fraction (EF), NYHA, diabetes, and CVA). Data were collected prospectively (mean duration of follow-up: 3.2 +/- 2.4 years). RESULTS Perioperative morbidity (re-operation for bleeding, low cardiac output, CVA, renal failure) was comparable among groups. Difference in mortality between the two groups was non-significant (7.0 vs. 3.5%, P = 0.67 in groups MR 2-3 vs. 0-1, respectively). At early echocardiographic follow-up, 7/58 patients (12.1%) within group MR grades 0-1 increased their MR to grades 2-3; among which only two remained with MR grades 2-3 at mid-term follow-up. Within MR group 2-3, 18/58 (31.0%) remained with MR grades 2-3 among which 7/18 (38.9%) decreased of at least one grade at follow-up. Eight year actuarial survival was comparable in both groups: MR grades 0-1 = 60.9% vs. MR grades 2-3 = 55.0%; P = 0.1. Actuarial survival of patients with MR grades 2-3 postoperatively was similar to patients with MR grades 0-1 (MR grades 0-1 = 59.0%, MR grades 2-3 = 58.9%, P = NS). CONCLUSIONS Presence of preoperative moderate functional MR (grades 2-3) in patients undergoing isolated AVR for aortic stenosis regresses in the majority of patients postoperatively and has no significant impact on perioperative morbidity or mortality, nor mid-term survival. Thus, moderate functional MR should be treated conservatively in the majority of patients especially in the elderly subjected to isolated AVR for aortic stenosis.

Medtronic Mosaic porcine bioprosthesis: Satisfactory early clinical performance

BACKGROUND The Medtronic (Minneapolis, MN) Mosaic porcine bioprosthesis is an investigational prosthesis which incorporates zero-pressure fixation, aortic root predilation, low profile stent, and alpha oleic acid antimineralization treatment. METHODS From September 1994 to August 1996, 289 patients (mean age 70 years, range, 28 to 88 years) had 227 (78.5%) aortic valve replacements and 62 (21.5%) mitral valve replacements. Concomitant procedures were performed in 61.2% (139) of aortic valve replacements and 54.8% (34) of mitral valve replacements. Of the aortic valve replacement group 70 (30.8%) were in the 61 to 70 age group and 134 (59.0%) were 71 years or older. Of the mitral valve replacements, 23 (37.1%) were 61 to 70 years and 30 (48.4%) 71 years or older. RESULTS The early mortality, overall, was 4.2% (12 of 289); for aortic valve replacement it was 4.0% (9) and for mitral valve replacement it was 4.8% (3). The late mortality for aortic valve replacement was 2.6% per patient-year (3 events, 1.3% of total) and for mitral valve replacement it was 3.3% per patient-year (one event, 1.6% of total). The reoperative rate for aortic valve replacement was 3.0% per patient-year (4), while there were no mitral valve replacement reoperations. The freedom from major thromboembolism was 97.3%+/-1.6% for aortic valve replacement and 94.7%+/-3.0% for mitral valve replacement at 1 to 1.5 years. The freedom from reoperation was 96.7%+/-1.7% for aortic valve replacement; there was no reoperation for mitral valve replacement. There were no cases of structural valve deterioration. In the aortic position the mean systolic gradient was low, approximately 11 mm Hg, across all sizes (range 8 to 12 mm Hg at 3 months and 10 to 13 mm Hg at 12 months). In the mitral position the mean diastolic gradient was approximately 5 mm Hg (range, 2 to 6 mm Hg) for all sizes 25 to 31 mm at the early and 1 year follow-up echocardiographic assessment. CONCLUSIONS The early clinical performance and in vivo hemodynamics are encouraging.

Long-Term Clinical and Echocardiographic Follow-Up of the Freestyle Stentless Aortic Bioprosthesis

Background— Stentless aortic bioprostheses were designed to provide enhanced hemodynamic performance and potentially greater longevity. The present report describes the outcomes of patients with the Freestyle stentless bioprosthesis followed for ⩽18 years. Methods and Results— Between 1993 and 2011, 430 patients underwent primary aortic valve replacement with a Freestyle bioprosthesis in the subcoronary position. Mean age was 68.2±8.2 years. All of the clinical and echocardiographic data were collected prospectively. Mean overall follow-up was 9.1±4.4 years and was complete in all of the patients. In-hospital mortality was 3.5% (n=15). Overall, 10- and 15-year survival were 60.7% and 35.0%, respectively. Fifty-one patients required reoperation during follow-up, including 27 for structural valve deterioration (SVD). Overall, freedom from reoperation was 91.0% and 75.0% at 10 and 15 years, whereas freedom from reoperation for SVD was 95.9% and 82.3%, respectively. At 10 and 15 years, freedom from reoperation for SVD was 94.0% and 62.6% for patients <60 years of age and 96.3% and 88.4% for patients ≥60 years of age (P=0.002). The median time to explant for SVD was 10.7 years. SVD presented mostly as acute, severe aortic insufficiency attributed to leaflet tear (77.8%). The independent risk factors for reoperation for SVD were age <60 years (P=0.001) and dyslipidemia (P=0.02). Conclusions— Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients >60 years of age. Severe aortic insufficiency with leaflet tear is the major mode of SVD leading to reoperation in these patients.

Medtronic Mosaic porcine bioprosthesis: Assessment of 12-year performance

BACKGROUND The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers. METHODS From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR). Concomitant coronary artery bypass grafting was performed with aortic valve replacement (45.4%) and mitral valve replacement (43.5%). Mean follow-ups were 7.5 years for aortic position and 7.3 years for mitral position. RESULTS Early mortalities were 2.8% for AVR and 3.0% for MVR. Late mortalities were 4.2%/patient-year for AVR and 5.1%/patient-year for MVR. Overall 12-year survivals were 55.8% ± 3.7% for AVR and 43.9% ± 7.4% for MVR. Twelve-year freedoms from valve-related mortality were 87.1% ± 3.1% for AVR and 82.5% ± 7.7% for MVR. Twelve-year freedoms from reoperation were 84.0% ± 3.3% for AVR and 82.5% ± 7.5% for MVR. Freedoms from structural valve deterioration (SVD) by explant reoperation at 12 years for AVR were 93.3% ± 2.6% for patients at least 60 years old and 75.9% ± 9.3% for patients younger than 60 years. Freedoms from SVD by explant reoperation at 10 years for MVR were 95.3% ± 7.8% for patients at least 70 years old and 84.0% ± 9.3% for patients younger than 70 years. Hemodynamic performance data at 1 year for AVR (sizes 21-27 mm) were mean systolic gradient range 13.7 ± 4.8 to 10.3 ± 3.2 mm Hg and effective orifice area range 1.5 ± 0.3 to 2.5 ± 0.4 cm(2). For MVR (sizes 25-31 mm), data were mean diastolic gradient range 6.7 ± 1.7 to 3.7 ± 0.9 mm Hg and effective orifice area range 1.9 ± 0.3 to 2.4 ± 0.6 cm(2). CONCLUSIONS Overall performance of Mosaic porcine bioprosthesis to 12 years is satisfactory. Freedoms from SVD by explant reoperation were most satisfactory for aortic position in patients at least 60 years old and mitral position in patients at least 70 years old. Overall actuarial freedom from SVD by explant reoperation is encouraging for patients with MVR.

Changes in Left Ventricular Mass and Function After Aortic Valve Replacement: A Comparison Between Stentless and Stented Bioprosthetic Valves

The objective of this study was to compare stentless bioprostheses with stented bioprostheses with regard to the postoperative changes in left ventricular (LV) mass and function. Forty patients with aortic stenosis undergoing valve replacement with a stentless (20 patients) or a stented (20 patients) bioprosthesis were evaluated early (baseline), 1 year, and 2 years after operation. Left ventricular mass index was calculated with the corrected American Society of Echocardiography formula. The relative changes between end-diastole and end-systole in LV mid-wall radius, length, and volume (ejection fraction) were determined with a previously validated model for dynamic geometry of the left ventricle. Overall, a significant decrease was found in LV mass index (from 155 +/- 30 to 112 +/- 23 g/m(2); P <.001) and a significant increase in longitudinal shortening (from 0.12 +/- 0.11 to 0.22 +/- 0.08; P <. 001), and ejection fractions (from 0.67 +/- 0.11 to 0.71 +/- 0.10; P =.017). No significant change was found in the mid-wall radius shortening fraction. Two years after surgery, the extent of LV mass regression was greater in stentless bioprostheses (-51 +/- 18 vs -35 +/- 17 g/m(2); P =.01), though the average mass index was similar in both groups (114 +/- 26 vs 110 +/- 20 g/m(2)). Also at 2 years, the longitudinal shortening fraction was greater in patients with a stentless bioprosthesis (0.25 +/- 0.07 vs 0.18 +/- 0.08; P =.03). In conclusion, this study suggests that the superior hemodynamic performance of stentless bioprostheses may have some benefits with regard to LV mass regression and function after aortic valve replacement. The significance of these benefits in terms of prognosis remains to be determined.

Medtronic mosaic porcine bioprosthesis: midterm investigational trial results

BACKGROUND The midterm clinical and hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis was evaluated in a regulatory trial. METHODS In nine Canadian centers, 802 bioprostheses (560 aortic and 242 mitral) were implanted between September 1994 and April 1999 in patients with a mean age of 70 years. RESULTS Survival for aortic valve replacement at 4 years was 84.4%+/-3.1%. Freedom from valve-related or unexplained death was 95.6%+/-1.9%; structural valve deterioration, 100.0%; reoperation, 96.2%+/-1.7%; major thromboembolism, 96.1%+/-1.8%; and major antithrombotic-related hemorrhage, 96.4%+/-1.7%. Echocardiographic derived mean systolic gradient was 13.4 mm Hg at 4 years with an indexed effective orifice area of 0.7 to 0.8 cm2/m2. A significant decrease in left ventricular mass was shown over time in all valve sizes. Survival for mitral valve replacement at 4 years was 79.2%+/-6.8%. Freedom from valve-related or unexplained death was 96.5%+/-3.4%; structural valve deterioration, 100%; reoperation, 97.0%+/-3.2%; major thromboembolism, 95.7%+/-3.8%; and major antithrombotic-related hemorrhage, 95.0%+/-4.2%. Echocardiographically measured averaged mean diastolic gradient was 4.5 mm Hg. CONCLUSIONS The Medtronic Mosaic bioprosthesis is safe and effective in both the aortic and mitral positions. The valve has low gradients in both positions and excellent left ventricular mass regression in the patients with aortic valve replacement.

Medtronic intact porcine bioprosthesis experience to twelve years

BACKGROUND The Medtronic Intact porcine bioprosthesis was further evaluated to determine the influence of zero-pressure glutaraldehyde fixation on structural valve deterioration (SVD). METHODS From 1986 through 1996, at three Canadian centers, 1,272 patients had 1,296 procedures: 836 aortic valve replacement (AVR), 332 mitral valve replacement (MVR), 14 tricuspid valve replacement, 3 pulmonary valve replacement, and 111 multiple valve replacements. The mean age of the patient population was 67 years (range 9 to 91 years). The total follow-up was 8,011 patient-years (mean 6.2 years). RESULTS The late mortality (overall) was 4.8% and 6.7% per patient-year for AVR with or without concomitant procedures, respectively; and 4.7% and 10.4% per patient-year for MVR, respectively. There were 51 cases of SVD (AVR 22 of 836; MVR 23 of 332; pulmonary valve replacement 1 of 3; and multiple valve replacement 5 of 111). The actuarial freedom from SVD at 12 years for AVR was 94.3%+/-3.3% for patients aged 61 to 70 years and 97.7%+/-1.1% for those more than 70 years; for MVR actuarial freedom from SVD at 12 years was 93.7%+/-3.9% for patients more than 70 years. The actual freedom at 12 years from SVD for AVR was 92.4%+/-3.1% for patients aged 51 to 60 years, 96.1%+/-2.1% for those 61 to 70 years, and 98.4%+/-0.7% for those older than 70 years; for MVR actual freedom from SVD at 12 years was 89.6%+/-3.2% for patients 61 to 70 years and 96.6%+/-3.4% for those more than 70 years. CONCLUSIONS The Medtronic Intact porcine bioprosthesis, formulated with tissue preservation at zero-pressure fixation, has encouraging freedom from structural failure.