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`Figure I. High-pulse repetition frequency Doppler recordings in a patient after valve
`replacement for aortic stenosis. Left, At baseline, a normal symmetric Doppler spectrum
`reaching 1 tnfs was observed. Middle, During nipride, the atterload reduction was associated
`with a dagger-shaped Doppler spectrum peaking in late systole at 3 mfs. Right, lnotropic
`stimulation by dobutamine resulted in a similar intracavitary flow velocity pattern with a
`maximal velocity of3.8 mils.
`
`Statistical Analyslsfl
`
`Results are expressed as mean plusr’minus SD. Unpaired and paired t tests
`were used to compare appropriate data. Fisher's exact test was performed for
`comparison of categorical variables. One—way ANOVA, followed by
`Bon‘ferroni's test, was performed for multiple comparisons. Sensitivity and
`specificity were calculated as usual. Multivariate analysis was performed
`separately on Doppler echocardiographic and catheterization data to detect
`their values in predicting postoperative AFV. Optimal diagnostic accuracy
`level for a given factor was defined as the value of the given factor at which
`sensitivity and specificity are equal. A value ofP less or equal to .05 was
`considered significant.
`
`Resultsfl
`
`All patients underwent both preoperative and postoperative Doppler
`echocardiographic studies. The latter was performed 7 plusi’minus 3 days
`(range, 2 to 10 days) after valve replacement After surgery, nipride was given
`in 93 patients and dobutamine in 96 patients, Three patients did not receiVe
`nipride because of persistent hypotension (< 100 mm Hg). Four patients
`received neither nipride nor dobutamine because AFV was present at rest (>
`3.? 1112’s).
`
`Hemodynamicsfl
`
`In the whole population, nipride induced a decrease in systolic pressure and
`an increase in heart rate (table I). Dobutamine infusion increased heart rate,
`whereas systolic blood pressure remained unchanged. Patients with resting
`AFV had significantly higher heart rates and lower systolic pressures at
`baseline and during dobutamine infusion compared with pati
`resting AFV. A comparison of patients according to the pres NORRED EXHIBIT 2012 _ page 1
`provoked AFV showed them to be similar with respect to he Medtronic, Inc., Medtronic Vascular, |nc.,
`& Medtronic Corevalve, LLC
`
`.
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`301 IR
`
`v. Troy R. Norred, M.D.
`Case |PR2014-00110
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`
`Figure I. High-pulse repetition frequency Doppler recordings in a patient after valve
`replacement for aortic stenosis. Left, At baseline. at normal symmetric Doppler spectrum
`teaching 1 this was observed. Middle, During nipride, the afterload reduction was associated
`with a dagger-shaped Doppler spectrum peaking in late systole at 3 mils. Right, lnotropic
`stimulation by dobutamine resulted in a similar intracavitary flow velocity pattern with a
`maximal velocity of 3.8 mils.
`
`Statistical Analyslsxl
`
`Results are expressed as mean plusfminus SD. Unpaired and paired t tests
`were used to compare appropriate data. Fishcr’s exact test was performed for
`comparison of categorical variables. One-way ANOVA, followed by
`Bonferroni's test, was performed for multiple comparisons. Sensitivity and
`specificity were calculated as usual. Multivariate analysis was performed
`separately on Doppler echocardiographic and catheterization data to detect
`their values in predicting postoperative AFV. Optimal diagnostic accuracy
`level for a given factor was defined as the value of the given factor at which
`sensitivity and specificity are equal. A value ofl’ less or equal to .05 was
`considered significant.
`
`Resultsll
`
`All patients underwent both preoperative and postoperative Doppler
`echocardiographic studies. The latter was performed 7 plusfminus 3 days
`(range, 2 to 10 days) after valve replacement. After surgery, nipride was given
`in 93 patients and dobutamine in 96 patients. Three patients did not receive
`nipride because of persistent hypotension (< 100 mm Hg). Four patients
`received neither nipride nor dobutamine because AFV was present at rest (5
`3.7 1113's).
`
`Hemodynamicsfl
`
`In the whole population, nipride induced a decrease in systolic pressure and
`an increase in heart rate (Table I). Dobutamine infusion increased heart rate,
`whereas systolic blood pressure remained unchanged. Patients with resting
`AFV had significantly higher heart rates and lower systolic pressures at
`baseline and during dobutamine infusion compared with patients without
`resting AFV. A comparison of patients according to the presence or absence of
`provoked AFV showed them to be similar with reSpect to heart rate, blood
`
`5 of IR
`
`NORRED EXHIBIT 2012 - Page 1
`
`Stillfllil 8154 [’M
`
`

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`\ i
`
`//
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`1/
`
`NORRED EXHIBIT 2012 - Page 2
`
`