JACC VOL. 67, NO. 6, 2016
Letters
FEBRUARY 16, 2016:732–6
There has been a significant increase in the utilization of FFR since the publication of FAME trial reflecting the increasing adoption of this procedure by the interventional community (Figure 1). In 2012, less than one-half of the discharges with a code for FFR had an associated code for PCI, which may represent a significant impact of FFR utilization on
3. Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction. Eur Heart J 2015;36:100–11. 4. Dattilo PB, Prasad A, Honeycutt E, Wang TY, Messenger JC. Contemporary patterns of fractional flow reserve and intravascular ultrasound use among patients undergoing percutaneous coronary intervention in the United States: insights from the National Cardiovascular Data Registry. J Am Coll Cardiol 2012;60:2337–9.
PCI volume over the past decade. Although the value of FFR in patients with ACS has been debated in the past, recent studies have demonstrated clinical utility (3). Our study has significant limitations. Data in NIS is based on diagnostic codes and the accuracy of each entry cannot be validated. However, many previous studies have utilized the same data sample. Secondly,
Comparison of the American PPCM Registry Data With International Registries
this is an inpatient sample and outpatient FFR procedures are likely to have been missed particularly “deferred cases” not undergoing PCI. We expect that the trends in the use of these procedures on an outpatient basis would parallel our results. Thirdly, in the visits that have codes for both FFR and PCI, we cannot differentiate if both procedures were performed on the same or different coronary arteries. Lastly, all deferred PCIs cannot be attributed to nonischemic FFR results alone, as some patients with positive FFR could have been referred for surgical revascularization. This study demonstrates increased adoption of FFR in clinical practice. Further research is required in understanding if FFR is used as recommended in current guidelines and if not, barriers to more universal adoption. *Naga V. Pothineni, MD Nishi S. Shah, MD Yogita Rochlani, MD Ramez Nairooz, MD Sameer Raina, MD Massoud A. Leesar, MD Barry F. Uretsky, MD Abdul Hakeem, MD *Division of Cardiology
We congratulate McNamara et al. (1) for these exciting new data on a cohort of 100 women diagnosed with peripartum cardiomyopathy (PPCM). This study adds important information with regard to ethnic differences and prognosis as the current management allows it. However, we noted that several patients had a left ventricular ejection fraction (LVEF) above 45% at the point defined as “baseline” (Figures 2 and 3), although the authors state in the Methods section that they used the inclusion criteria of LVEF55% as the cutoff? Finally, the authors state that 15% of PPCM pa-
University of Arkansas for Medical Sciences
tients in their collective were breastfeeding at the
4301 West Markham Street, #532
time of diagnosis. Looking at the epidemiological
Little Rock 72205
data published by the Centers for Disease Control and
Arkansas
Prevention in 2014, 79% of all women in the United
E-mail: [email protected]
States are breastfeeding their newborns and 49% are
http://dx.doi.org/10.1016/j.jacc.2015.11.042
still breastfeeding 6 months after delivery (4).
Please note: All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
REFERENCES 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–24. 2. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med 2012;367:991–1001.
Why was the rate of breastfeeding mothers among PPCM patients so low? With regard to outcome, what was the baseline LVEF in breastfeeding PPCM patients and how long did they continue breastfeeding after inclusion? Importantly, no controlled clinical studies have ever been performed analyzing the effects of heart failure medication transferred to the infant in the
733
734
JACC VOL. 67, NO. 6, 2016
Letters
FEBRUARY 16, 2016:732–6
breast milk. By contrast, data from our team has
advantage of an experienced core echocardiography
demonstrated normal growth percentiles and no
laboratory, which reviewed echocardiograms in a
adverse outcome for the infants in a collective of
blinded fashion and directly calculated LVEFs. All fig-
PPCM patients in South Africa (PPCM patients mainly
ures and analyses for our publication used the values
living in Soweto and rural South African regions)
provided by the core laboratory. As in most heart fail-
where breastfeeding has been terminated (5), sug-
ure clinical trials, these core calculations of LVEF ten-
gesting no disadvantage for infants if their severely
ded to be higher than the local clinical assessment.
diseased mothers did not nurse them.
The referenced European registry (2) does not
Taken together, we feel that the conclusion of the
mention any core laboratory assessment of LVEF and,
authors that breastfeeding is safe in PPCM patients
we assume, utilized the local clinical value for their
appears premature and eventually even misleading.
analysis. If this is the case, then the LVEFs at entry of these 2 cohorts are very comparable. Recovery in the
*Denise Hilfiker-Kleiner, PhD Karen Sliwa, MD, PhD Johann Bauersachs, MD
IPAC study to an LVEF >0.50 was evident in 72% of
*Department of Cardiology and Angiology
LVEF >0.55 in 52% of IPAC subjects, again compara-
Hannover Medical School
ble to the 47% of women in the European registry.
Carl-Neuberg Strasse 1
The 2 cohorts are similar in their outcomes and
30625 Hannover
contemporary
Germany
bromocriptine was used in 67% of the women of the
subjects; applying the standard used in the European registry to our study demonstrates recovery to an
therapy
with
the
exception
that
E-mail: hilfi[email protected]
European registry, but only 1% of the IPAC cohort.
http://dx.doi.org/10.1016/j.jacc.2015.09.112
Importantly
Please note: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
dysfunction and greater remodeling at study entry
REFERENCES
tial transmission of medication must be taken into
1. McNamara DM, Elkayam U, Alharethi R, et al. Clinical outcomes for peripartum cardiomyopathy in North America: results of the IPAC study (Investigations of Pregnancy-Associated Cardiomyopathy). J Am Coll Cardiol 2015;66:905–14.
account when making decisions in the best interests of
our
studies
show
that
severe
LV
were associated with less recovery. In terms of breastfeeding, we agree that the poten-
2. Blauwet LA, Libhaber E, Forster O, et al. Predictors of outcome in 176 South African patients with peripartum cardiomyopathy. Heart 2013;99: 308–13. 3. Haghikia A, Podewski E, Libhaber E, et al. Phenotyping and outcome on contemporary management in a German cohort of patients with peripartum cardiomyopathy. Basic Res Cardiol 2013;108:366. 4. Centers for Disease Control. Breastfeeding Report Card: United States/
the mother and child, and we do not suggest in our study that breastfeeding is “safe.” However, we specifically note that there was no evidence of an adverse impact of breastfeeding on myocardial recovery because the mean LVEF at 12 months for the 15 women who breastfed was 0.57 0.04. These women tended to be less ill (80% were New York Heart Association functional class I or II), and we do not have data on how
2014. Available at: http://www.cdc.gov/breastfeeding/pdf/2014breast feedingreportcard.pdf. Accessed September 1, 2015.
long they breastfed. Concerns about the metabolic
5. Sliwa K, Blauwet L, Tibazarwa K, et al. Evaluation of bromocriptine in the treatment of acute severe peripartum cardiomyopathy: a proof-of-concept pilot study. Circulation 2010;121:1465–73.
transmission of medications to the child frequently
REPLY: Comparison of the American PPCM Registry Data With International Registries
demands on maternal health or potential maternal leads to a recommendation against breastfeeding, particularly in women with more severe heart failure. However, our study does not provide any evidence to support a recommendation against breastfeeding based on a theoretical impact on recovery. Although we appreciate the small pilot study referenced (3), the
We appreciate the work of Drs. Hilfiker-Kleiner and
hidden costs of a prohibition of breastfeeding in terms
colleagues on European and South African cohorts
of neonatal health and development remain a concern
with peripartum cardiomyopathy. They have raised
that should be considered in making the best recom-
important questions and we are happy to clarify. First,
mendation for mother and child.
the entry criteria for women in the IPAC (Investigations of Pregnancy-Associated Cardiomyopathy) study (1) were based on the clinical assessment of left ventricular ejection fraction (LVEF) at their local institutions, and all subjects met the entry criteria of a local clinical LVEF estimated at
Letters
FEBRUARY 16, 2016:732–6
There has been a significant increase in the utilization of FFR since the publication of FAME trial reflecting the increasing adoption of this procedure by the interventional community (Figure 1). In 2012, less than one-half of the discharges with a code for FFR had an associated code for PCI, which may represent a significant impact of FFR utilization on
3. Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction. Eur Heart J 2015;36:100–11. 4. Dattilo PB, Prasad A, Honeycutt E, Wang TY, Messenger JC. Contemporary patterns of fractional flow reserve and intravascular ultrasound use among patients undergoing percutaneous coronary intervention in the United States: insights from the National Cardiovascular Data Registry. J Am Coll Cardiol 2012;60:2337–9.
PCI volume over the past decade. Although the value of FFR in patients with ACS has been debated in the past, recent studies have demonstrated clinical utility (3). Our study has significant limitations. Data in NIS is based on diagnostic codes and the accuracy of each entry cannot be validated. However, many previous studies have utilized the same data sample. Secondly,
Comparison of the American PPCM Registry Data With International Registries
this is an inpatient sample and outpatient FFR procedures are likely to have been missed particularly “deferred cases” not undergoing PCI. We expect that the trends in the use of these procedures on an outpatient basis would parallel our results. Thirdly, in the visits that have codes for both FFR and PCI, we cannot differentiate if both procedures were performed on the same or different coronary arteries. Lastly, all deferred PCIs cannot be attributed to nonischemic FFR results alone, as some patients with positive FFR could have been referred for surgical revascularization. This study demonstrates increased adoption of FFR in clinical practice. Further research is required in understanding if FFR is used as recommended in current guidelines and if not, barriers to more universal adoption. *Naga V. Pothineni, MD Nishi S. Shah, MD Yogita Rochlani, MD Ramez Nairooz, MD Sameer Raina, MD Massoud A. Leesar, MD Barry F. Uretsky, MD Abdul Hakeem, MD *Division of Cardiology
We congratulate McNamara et al. (1) for these exciting new data on a cohort of 100 women diagnosed with peripartum cardiomyopathy (PPCM). This study adds important information with regard to ethnic differences and prognosis as the current management allows it. However, we noted that several patients had a left ventricular ejection fraction (LVEF) above 45% at the point defined as “baseline” (Figures 2 and 3), although the authors state in the Methods section that they used the inclusion criteria of LVEF55% as the cutoff? Finally, the authors state that 15% of PPCM pa-
University of Arkansas for Medical Sciences
tients in their collective were breastfeeding at the
4301 West Markham Street, #532
time of diagnosis. Looking at the epidemiological
Little Rock 72205
data published by the Centers for Disease Control and
Arkansas
Prevention in 2014, 79% of all women in the United
E-mail: [email protected]
States are breastfeeding their newborns and 49% are
http://dx.doi.org/10.1016/j.jacc.2015.11.042
still breastfeeding 6 months after delivery (4).
Please note: All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
REFERENCES 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–24. 2. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med 2012;367:991–1001.
Why was the rate of breastfeeding mothers among PPCM patients so low? With regard to outcome, what was the baseline LVEF in breastfeeding PPCM patients and how long did they continue breastfeeding after inclusion? Importantly, no controlled clinical studies have ever been performed analyzing the effects of heart failure medication transferred to the infant in the
733
734
JACC VOL. 67, NO. 6, 2016
Letters
FEBRUARY 16, 2016:732–6
breast milk. By contrast, data from our team has
advantage of an experienced core echocardiography
demonstrated normal growth percentiles and no
laboratory, which reviewed echocardiograms in a
adverse outcome for the infants in a collective of
blinded fashion and directly calculated LVEFs. All fig-
PPCM patients in South Africa (PPCM patients mainly
ures and analyses for our publication used the values
living in Soweto and rural South African regions)
provided by the core laboratory. As in most heart fail-
where breastfeeding has been terminated (5), sug-
ure clinical trials, these core calculations of LVEF ten-
gesting no disadvantage for infants if their severely
ded to be higher than the local clinical assessment.
diseased mothers did not nurse them.
The referenced European registry (2) does not
Taken together, we feel that the conclusion of the
mention any core laboratory assessment of LVEF and,
authors that breastfeeding is safe in PPCM patients
we assume, utilized the local clinical value for their
appears premature and eventually even misleading.
analysis. If this is the case, then the LVEFs at entry of these 2 cohorts are very comparable. Recovery in the
*Denise Hilfiker-Kleiner, PhD Karen Sliwa, MD, PhD Johann Bauersachs, MD
IPAC study to an LVEF >0.50 was evident in 72% of
*Department of Cardiology and Angiology
LVEF >0.55 in 52% of IPAC subjects, again compara-
Hannover Medical School
ble to the 47% of women in the European registry.
Carl-Neuberg Strasse 1
The 2 cohorts are similar in their outcomes and
30625 Hannover
contemporary
Germany
bromocriptine was used in 67% of the women of the
subjects; applying the standard used in the European registry to our study demonstrates recovery to an
therapy
with
the
exception
that
E-mail: hilfi[email protected]
European registry, but only 1% of the IPAC cohort.
http://dx.doi.org/10.1016/j.jacc.2015.09.112
Importantly
Please note: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
dysfunction and greater remodeling at study entry
REFERENCES
tial transmission of medication must be taken into
1. McNamara DM, Elkayam U, Alharethi R, et al. Clinical outcomes for peripartum cardiomyopathy in North America: results of the IPAC study (Investigations of Pregnancy-Associated Cardiomyopathy). J Am Coll Cardiol 2015;66:905–14.
account when making decisions in the best interests of
our
studies
show
that
severe
LV
were associated with less recovery. In terms of breastfeeding, we agree that the poten-
2. Blauwet LA, Libhaber E, Forster O, et al. Predictors of outcome in 176 South African patients with peripartum cardiomyopathy. Heart 2013;99: 308–13. 3. Haghikia A, Podewski E, Libhaber E, et al. Phenotyping and outcome on contemporary management in a German cohort of patients with peripartum cardiomyopathy. Basic Res Cardiol 2013;108:366. 4. Centers for Disease Control. Breastfeeding Report Card: United States/
the mother and child, and we do not suggest in our study that breastfeeding is “safe.” However, we specifically note that there was no evidence of an adverse impact of breastfeeding on myocardial recovery because the mean LVEF at 12 months for the 15 women who breastfed was 0.57 0.04. These women tended to be less ill (80% were New York Heart Association functional class I or II), and we do not have data on how
2014. Available at: http://www.cdc.gov/breastfeeding/pdf/2014breast feedingreportcard.pdf. Accessed September 1, 2015.
long they breastfed. Concerns about the metabolic
5. Sliwa K, Blauwet L, Tibazarwa K, et al. Evaluation of bromocriptine in the treatment of acute severe peripartum cardiomyopathy: a proof-of-concept pilot study. Circulation 2010;121:1465–73.
transmission of medications to the child frequently
REPLY: Comparison of the American PPCM Registry Data With International Registries
demands on maternal health or potential maternal leads to a recommendation against breastfeeding, particularly in women with more severe heart failure. However, our study does not provide any evidence to support a recommendation against breastfeeding based on a theoretical impact on recovery. Although we appreciate the small pilot study referenced (3), the
We appreciate the work of Drs. Hilfiker-Kleiner and
hidden costs of a prohibition of breastfeeding in terms
colleagues on European and South African cohorts
of neonatal health and development remain a concern
with peripartum cardiomyopathy. They have raised
that should be considered in making the best recom-
important questions and we are happy to clarify. First,
mendation for mother and child.
the entry criteria for women in the IPAC (Investigations of Pregnancy-Associated Cardiomyopathy) study (1) were based on the clinical assessment of left ventricular ejection fraction (LVEF) at their local institutions, and all subjects met the entry criteria of a local clinical LVEF estimated at
