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NEW ORLEANS – Frequent, noninvasive measurement of pulmonary artery pressure in patients with advanced heart failure and an implanted CardioMEMS device that allows this measurement led to management that produced a substantial reduction in heart failure hospitalizations, compared with each patient’s history, in a real-world study.
The Food and Drug Administration–mandated CardioMEMS Post-Approval Study included 1,200 patients who received CardioMEMS implants after it received U.S. marketing approval. The study showed that when clinicians and patients used the device in routine practice, presumably as part of a structured management system designed to take advantage of the pulmonary artery (PA) pressures the device provides, the result safely produced a 58% cut in heart failure hospitalizations during the year following device placement when compared to each patient’s own hospitalization history during the year before they got the CardioMEMS device, David M. Shavelle, MD, said at the at the annual meeting of the American College of Cardiology. This statistically significant result for the study’s primary endpoint showed an absolute reduction in the average rate of heart failure hospitalizations from 1.24 per patient during the year before the CardioMEMS placement to 0.52 hospitalizations per patient during the 12 months after placement, an average reduction of 0.72 hospitalizations/patient, said Dr. Shavelle, an interventional cardiologist at the University of Southern California in Los Angeles.
Another notable finding was that this benefit from CardioMEMS placement and use occurred at roughly similar rates in patients with New York Heart Association class III heart failure regardless of whether they had a reduced ejection fraction (40% or less), a mid-range ejection fraction (41%-50%), or preserved ejection fraction (greater than 50%), making CardioMEMS use one of the few treatments to produce any proven benefit in patients with heart failure with preserved ejection fraction. In that subgroup, 30% of the 1,200 enrolled patients had an average cut of 0.68 hospitalizations in the year after CardioMEMS implantation, a 61% drop, relative to the year before they received the device.
The results also fulfilled the study’s two prespecified safety measures. Among the 1,214 patients in the study assessed for safety, which included the 1,200 patients who received the device and 4 patients in whom placement failed, 4 patients had a device or system related complication during the study, a 0.3% rate, compared with a prespecified objective performance criteria of less than 20%. Among the 1,200 patients with a functioning CardioMEMS sensor, one patient (0.1%) had a device failure, compared with the study’s objective performance criteria of less than 10%.
The performance of the CardioMEMS device and the benefit it provided to patients in the post-approval study closely tracked its performance during the published pivotal trial (Lancet. 2011 Feb 19;377[9766]:658-66). On the basis of the pivotal trial results, the FDA approved CardioMEMS for U.S. marketing in 2014. Since then, the company has reported that about 10,000 U.S. heart failure patients have received these devices, Dr. Shavelle said.
“The benefit was seen across the range of ejection fractions; that’s very important,” commented Gurusher Panjrath, MD, director of advanced heart failure at George Washington University in Washington and a designated discussant for Dr. Shavelle’s report. “The safety seemed very good, and the efficacy was consistent” with prior reports. “There also was high compliance. The key to success is the structure” of patient management, Dr. Pangroth said. “The data are limited by who is monitoring patients and their data and how much of that contact influences patient outcomes.”
That final comment by Dr. Panjrath highlighted the biggest caveat that heart failure clinicians have raised about judging the efficacy of CardioMEMS. To achieve clinical efficacy, the implanted device requires diligent, virtually daily interrogation and data transmission by the patient, assessment of a large amount of data for each patient by the patient’s clinical team, and responsiveness by the patient to medication adjustments directed by the clinical team to deal with episodes of rising PA pressure.
“The device itself has no benefit. It’s the actions prompted by the device that have benefit,” noted Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago and a second designated discussant for the report.
Dr. Shavelle agreed that for the CardioMEMS device to have an impact, one basic requirement is to identify patients who will cooperate with data collection and transmission and also with changes in their medications that are sent to them in response to PA pressure changes. This means selecting patients who appear to have problems with volume overload, including prior hospitalizations for decompensation, and patients who are comfortable interacting with their clinical-care providers. It also means excluding patients who are too sick to benefit from this intervention. He estimated that at his center more than 95% of class III heart failure patients who qualified for inclusion in the post-approval study by clinical criteria were also judged reasonable recipients of the device based on their willingness to cooperate with this system. He also estimated that at the University of Southern California the heart failure clinical team is now caring for about 150 patients with a CardioMEMS device implanted.
Another concern is teasing apart the specific benefit of collecting and using PA pressure data from the contact that the clinical team maintains with CardioMEMS patients.
“If nurses are contacting patients more often, is it the device or the communication? We need to look at that very carefully in a study that had no control group,” Dr. Yancy said in an interview. Contact with a nurse “is the best thing you can do for heart failure patients.”
Dr. Shavelle countered that several reports from past studies that assessed case management and regular monitoring of and contact with heart failure patients but without PA pressure data failed to showed any consistent benefit to patients.
“If you pick the right patients, CardioMEMS works. There is no question in my mind that the device works,” Dr. Shavelle said in an interview. “If you pick the wrong patient, who will not send the data or follow dose changes, then it won’t work.”
The study was sponsored by Abbott, the company that markets the CardioMEMS HF System. Dr. Shavelle has been a consultant to and speaker on behalf of Abbott Vascular and he has received research funding from Abbott Vascular, Abiomed, Biocardia, and V-Wave. Dr. Yancy had an unspecified financial relationship with Abbott Laboratories. Dr. Panjrath had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Shavelle DM et al. American College of Cardiology annual meeting, abstract 405-16.
NEW ORLEANS – Frequent, noninvasive measurement of pulmonary artery pressure in patients with advanced heart failure and an implanted CardioMEMS device that allows this measurement led to management that produced a substantial reduction in heart failure hospitalizations, compared with each patient’s history, in a real-world study.
The Food and Drug Administration–mandated CardioMEMS Post-Approval Study included 1,200 patients who received CardioMEMS implants after it received U.S. marketing approval. The study showed that when clinicians and patients used the device in routine practice, presumably as part of a structured management system designed to take advantage of the pulmonary artery (PA) pressures the device provides, the result safely produced a 58% cut in heart failure hospitalizations during the year following device placement when compared to each patient’s own hospitalization history during the year before they got the CardioMEMS device, David M. Shavelle, MD, said at the at the annual meeting of the American College of Cardiology. This statistically significant result for the study’s primary endpoint showed an absolute reduction in the average rate of heart failure hospitalizations from 1.24 per patient during the year before the CardioMEMS placement to 0.52 hospitalizations per patient during the 12 months after placement, an average reduction of 0.72 hospitalizations/patient, said Dr. Shavelle, an interventional cardiologist at the University of Southern California in Los Angeles.
Another notable finding was that this benefit from CardioMEMS placement and use occurred at roughly similar rates in patients with New York Heart Association class III heart failure regardless of whether they had a reduced ejection fraction (40% or less), a mid-range ejection fraction (41%-50%), or preserved ejection fraction (greater than 50%), making CardioMEMS use one of the few treatments to produce any proven benefit in patients with heart failure with preserved ejection fraction. In that subgroup, 30% of the 1,200 enrolled patients had an average cut of 0.68 hospitalizations in the year after CardioMEMS implantation, a 61% drop, relative to the year before they received the device.
The results also fulfilled the study’s two prespecified safety measures. Among the 1,214 patients in the study assessed for safety, which included the 1,200 patients who received the device and 4 patients in whom placement failed, 4 patients had a device or system related complication during the study, a 0.3% rate, compared with a prespecified objective performance criteria of less than 20%. Among the 1,200 patients with a functioning CardioMEMS sensor, one patient (0.1%) had a device failure, compared with the study’s objective performance criteria of less than 10%.
The performance of the CardioMEMS device and the benefit it provided to patients in the post-approval study closely tracked its performance during the published pivotal trial (Lancet. 2011 Feb 19;377[9766]:658-66). On the basis of the pivotal trial results, the FDA approved CardioMEMS for U.S. marketing in 2014. Since then, the company has reported that about 10,000 U.S. heart failure patients have received these devices, Dr. Shavelle said.
“The benefit was seen across the range of ejection fractions; that’s very important,” commented Gurusher Panjrath, MD, director of advanced heart failure at George Washington University in Washington and a designated discussant for Dr. Shavelle’s report. “The safety seemed very good, and the efficacy was consistent” with prior reports. “There also was high compliance. The key to success is the structure” of patient management, Dr. Pangroth said. “The data are limited by who is monitoring patients and their data and how much of that contact influences patient outcomes.”
That final comment by Dr. Panjrath highlighted the biggest caveat that heart failure clinicians have raised about judging the efficacy of CardioMEMS. To achieve clinical efficacy, the implanted device requires diligent, virtually daily interrogation and data transmission by the patient, assessment of a large amount of data for each patient by the patient’s clinical team, and responsiveness by the patient to medication adjustments directed by the clinical team to deal with episodes of rising PA pressure.
“The device itself has no benefit. It’s the actions prompted by the device that have benefit,” noted Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago and a second designated discussant for the report.
Dr. Shavelle agreed that for the CardioMEMS device to have an impact, one basic requirement is to identify patients who will cooperate with data collection and transmission and also with changes in their medications that are sent to them in response to PA pressure changes. This means selecting patients who appear to have problems with volume overload, including prior hospitalizations for decompensation, and patients who are comfortable interacting with their clinical-care providers. It also means excluding patients who are too sick to benefit from this intervention. He estimated that at his center more than 95% of class III heart failure patients who qualified for inclusion in the post-approval study by clinical criteria were also judged reasonable recipients of the device based on their willingness to cooperate with this system. He also estimated that at the University of Southern California the heart failure clinical team is now caring for about 150 patients with a CardioMEMS device implanted.
Another concern is teasing apart the specific benefit of collecting and using PA pressure data from the contact that the clinical team maintains with CardioMEMS patients.
“If nurses are contacting patients more often, is it the device or the communication? We need to look at that very carefully in a study that had no control group,” Dr. Yancy said in an interview. Contact with a nurse “is the best thing you can do for heart failure patients.”
Dr. Shavelle countered that several reports from past studies that assessed case management and regular monitoring of and contact with heart failure patients but without PA pressure data failed to showed any consistent benefit to patients.
“If you pick the right patients, CardioMEMS works. There is no question in my mind that the device works,” Dr. Shavelle said in an interview. “If you pick the wrong patient, who will not send the data or follow dose changes, then it won’t work.”
The study was sponsored by Abbott, the company that markets the CardioMEMS HF System. Dr. Shavelle has been a consultant to and speaker on behalf of Abbott Vascular and he has received research funding from Abbott Vascular, Abiomed, Biocardia, and V-Wave. Dr. Yancy had an unspecified financial relationship with Abbott Laboratories. Dr. Panjrath had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Shavelle DM et al. American College of Cardiology annual meeting, abstract 405-16.
NEW ORLEANS – Frequent, noninvasive measurement of pulmonary artery pressure in patients with advanced heart failure and an implanted CardioMEMS device that allows this measurement led to management that produced a substantial reduction in heart failure hospitalizations, compared with each patient’s history, in a real-world study.
The Food and Drug Administration–mandated CardioMEMS Post-Approval Study included 1,200 patients who received CardioMEMS implants after it received U.S. marketing approval. The study showed that when clinicians and patients used the device in routine practice, presumably as part of a structured management system designed to take advantage of the pulmonary artery (PA) pressures the device provides, the result safely produced a 58% cut in heart failure hospitalizations during the year following device placement when compared to each patient’s own hospitalization history during the year before they got the CardioMEMS device, David M. Shavelle, MD, said at the at the annual meeting of the American College of Cardiology. This statistically significant result for the study’s primary endpoint showed an absolute reduction in the average rate of heart failure hospitalizations from 1.24 per patient during the year before the CardioMEMS placement to 0.52 hospitalizations per patient during the 12 months after placement, an average reduction of 0.72 hospitalizations/patient, said Dr. Shavelle, an interventional cardiologist at the University of Southern California in Los Angeles.
Another notable finding was that this benefit from CardioMEMS placement and use occurred at roughly similar rates in patients with New York Heart Association class III heart failure regardless of whether they had a reduced ejection fraction (40% or less), a mid-range ejection fraction (41%-50%), or preserved ejection fraction (greater than 50%), making CardioMEMS use one of the few treatments to produce any proven benefit in patients with heart failure with preserved ejection fraction. In that subgroup, 30% of the 1,200 enrolled patients had an average cut of 0.68 hospitalizations in the year after CardioMEMS implantation, a 61% drop, relative to the year before they received the device.
The results also fulfilled the study’s two prespecified safety measures. Among the 1,214 patients in the study assessed for safety, which included the 1,200 patients who received the device and 4 patients in whom placement failed, 4 patients had a device or system related complication during the study, a 0.3% rate, compared with a prespecified objective performance criteria of less than 20%. Among the 1,200 patients with a functioning CardioMEMS sensor, one patient (0.1%) had a device failure, compared with the study’s objective performance criteria of less than 10%.
The performance of the CardioMEMS device and the benefit it provided to patients in the post-approval study closely tracked its performance during the published pivotal trial (Lancet. 2011 Feb 19;377[9766]:658-66). On the basis of the pivotal trial results, the FDA approved CardioMEMS for U.S. marketing in 2014. Since then, the company has reported that about 10,000 U.S. heart failure patients have received these devices, Dr. Shavelle said.
“The benefit was seen across the range of ejection fractions; that’s very important,” commented Gurusher Panjrath, MD, director of advanced heart failure at George Washington University in Washington and a designated discussant for Dr. Shavelle’s report. “The safety seemed very good, and the efficacy was consistent” with prior reports. “There also was high compliance. The key to success is the structure” of patient management, Dr. Pangroth said. “The data are limited by who is monitoring patients and their data and how much of that contact influences patient outcomes.”
That final comment by Dr. Panjrath highlighted the biggest caveat that heart failure clinicians have raised about judging the efficacy of CardioMEMS. To achieve clinical efficacy, the implanted device requires diligent, virtually daily interrogation and data transmission by the patient, assessment of a large amount of data for each patient by the patient’s clinical team, and responsiveness by the patient to medication adjustments directed by the clinical team to deal with episodes of rising PA pressure.
“The device itself has no benefit. It’s the actions prompted by the device that have benefit,” noted Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago and a second designated discussant for the report.
Dr. Shavelle agreed that for the CardioMEMS device to have an impact, one basic requirement is to identify patients who will cooperate with data collection and transmission and also with changes in their medications that are sent to them in response to PA pressure changes. This means selecting patients who appear to have problems with volume overload, including prior hospitalizations for decompensation, and patients who are comfortable interacting with their clinical-care providers. It also means excluding patients who are too sick to benefit from this intervention. He estimated that at his center more than 95% of class III heart failure patients who qualified for inclusion in the post-approval study by clinical criteria were also judged reasonable recipients of the device based on their willingness to cooperate with this system. He also estimated that at the University of Southern California the heart failure clinical team is now caring for about 150 patients with a CardioMEMS device implanted.
Another concern is teasing apart the specific benefit of collecting and using PA pressure data from the contact that the clinical team maintains with CardioMEMS patients.
“If nurses are contacting patients more often, is it the device or the communication? We need to look at that very carefully in a study that had no control group,” Dr. Yancy said in an interview. Contact with a nurse “is the best thing you can do for heart failure patients.”
Dr. Shavelle countered that several reports from past studies that assessed case management and regular monitoring of and contact with heart failure patients but without PA pressure data failed to showed any consistent benefit to patients.
“If you pick the right patients, CardioMEMS works. There is no question in my mind that the device works,” Dr. Shavelle said in an interview. “If you pick the wrong patient, who will not send the data or follow dose changes, then it won’t work.”
The study was sponsored by Abbott, the company that markets the CardioMEMS HF System. Dr. Shavelle has been a consultant to and speaker on behalf of Abbott Vascular and he has received research funding from Abbott Vascular, Abiomed, Biocardia, and V-Wave. Dr. Yancy had an unspecified financial relationship with Abbott Laboratories. Dr. Panjrath had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Shavelle DM et al. American College of Cardiology annual meeting, abstract 405-16.
REPORTING FROM ACC 2019