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Describing Our Heart Failure (HF) CardioMEMS™ Program: Our Experience at a Single Center Academic Institution
S100 Journal of Cardiac Failure Vol. 23 No. 8S August 2017 277 Describing Our Heart Failure (HF) CardioMEMS™ Program: Our Experience at a Single Center Academic Institution Michael Pudlo, Jerry Estep, Barry Trachtenberg, Myung Park, Sayali Ketkar, Arvind Bhimaraj; Houston Methodist Hospital, Houston, Texas Background: About 5.7 million adults in the United States currently have heart failure leading to over 1 million hospital admission annually, and costing 40 billion in annual costs (CDC, 2016). Statistically, roughly half of all people who develop HF die within five years (CDC, 2016). The CardioMEMS™ HF System is currently the only FDA approved implantable system for monitoring Pulmonary Artery (PA) pressures for patients with New York Heart Association (NYHA) functional class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure. The CHAMPION trial demonstrated a 37% reduction in hospital admissions in the treatment group (n = 270) compared to the control group (n = 280). Objective: A quality review of de-identified patients, describing our current workflow/ process for post implant CardioMEMS™ device patients as well as review hospital readmission rates, mortality, and adherence to the monitoring. Method: As part of a quality HF initiative, the advanced academic HF cardiology service who implanted the CardioMEMS™ devices created an algorithm for out-patient management for every patient implanted. The identified Nurse Practitioner (NP) became the identified champion to monitor the PA’s pressures remotely. Please see the attached algorithm that was used in management. The NP would contact the implanting and overseeing physician with recommended medication changes as well as appropriate follow-up and monitoring in the Heart Failure Disease Management (HFDM) clinic. An on-going deidentified quality data was reviewed for compliance, readmission, all-cause mortality, and basic demographics. Results: Since October, 2014, the academic advanced HF cardiology service has implanted 39 CardioMEMS™ devices. A de-identified review of the demographics include: 67% of the implanted patients were Caucasian and 54% male. From October, 2014 through December 1st, 2016, all-cause readmission rate for this de-identified patient population is 27%. Two patients received a Left Assist Ventricular Device (LVAD), two patients have received a heart transplant. All-cause mortality for this patient population is 7.8% (n = 3). Conclusion: Continued monitoring of the de-identified patient population is needed. As more implants are completed, larger prospective quality reviews will be needed. The described process and workflow has demonstrated the ability to keep advanced HF patients out of the hospital as well as continued close monitoring on an out-patient basis.
278 Comparing Measures to Assess Health-Related Quality of Life in Patients with Heartfailure with Preserved Ejection Fraction Rebecca Napier, Steven McNulty, David T. Eton, Margaret M. Redfield, Omar AbouEzzeddine, Shannon M. Dunlay; Mayo Clinic Rochester, Rochester, Minnesota Introduction: The ability to accurately assess health-related quality of life (HRQOL) in patients with heart failure (HF) is vital to clinical practice. The most widely accepted tools to assess HRQOL in HF are the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ). However, their validity and reliability have not been compared in patients with HF with preserved ejection fraction (HFpEF). Hypothesis: We hypothesized that the MLHFQ and KCCQ would both be reliable and valid in HFpEF, and the KCCQ would be more sensitive to changes in clinical status. Methods: We compared the reliability, validity, and responsiveness to change of the MLHFQ and KCCQ in chronic stable HFpEF patients enrolled in the Nitrate Effect on Activity Tolerance in Heart Failure trial (n = 110). Scores for the MLHFQ (range 0–105, higher = worse HRQOL) and KCCQ (range 0–100, higher = better HRQOL) and their subscales were calculated at baseline and 6 weeks. Internal consistency reliability was assessed using Cronbach’s α. The associations of MLHFQ and KCCQ with New York Heart Association (NYHA) functional class and 6 minute walk test (6MWT) at baseline were assessed using Spearman correlations (rs). Changes in MLHFQ and KCCQ from baseline to 6 weeks were compared with changes in the 6MWT using responsiveness statistics. Results: At baseline, the mean (standard deviation) MLHFQ total and KCCQ overall summary scores were 43.1 (24.6) and 56.1 (23.7). The proportions of participants with improvement (≥5 point improvement), no change, and decline (≥5 point worsening) in scores from baseline to 6 weeks were 55%, 28%, and 17% for the MLHFQ and 44%, 40%, and 16% for the KCCQ. Internal consistency was good to excellent (α ≥ 0.8) for both MLHFQ and five of six KCCQ domains at baseline and 6 weeks. Correlations with NYHA functional class and 6MWT were slightly stronger for the KCCQ summary score than the MLHFQ total score (Table). The MLHFQ total score was most responsive to improvements in 6MWT as indicated by changes in responsiveness statistics including effect size (Table). Conclusion: These data suggest that both the MLHFQ and KCCQ are reliable and valid tools to assess HRQOL in HFpEF. The KCCQ was more strongly correlated with baseline functional status parameters, while the MLHFQ was more responsive to improvement in 6MWT over time.
279 Sex-Specific Outcomes after MitraClip Implantation: A Systematic Review and Meta-Analysis Vanessa Blumer, Rodrigo Mendirichaga, Sandra Chaparro; University of Miami / Jackson Memorial Hospital, Miami, Florida Background: Women have worse long-term outcomes following mitral valve surgery for mitral regurgitation than men. Transcatheter edge-to-edge mitral valve repair with the use of MitraClip has been introduced as an alternative for patients with a prohibitivelyhigh surgical risk. Sex-specific data following MitraClip implantation presents conflicting results. Methods: We searched Medline, Embase, and Cochrane library from January 2005 to March 2017 for publications reporting sex-specific outcomes in patients undergoing MitraClip implantation. Outcomes were compared under the randomeffects model and heterogeneity examined via Chi2 and I2 statistics. Results: A total of 7 studies including 1798 patients undergoing MitraClip implantation (38% female) were included in the analysis. Acute device success rate and procedural complications were similar for both groups; however, men were more likely to require >1 clip (OR 0.52; CI 95% 0.39–0.69; P < .001). Mortality, hospital readmission, and residual MR ≥ 2 + after implantation were similar at 12-months. Men were more likely to report NYHA functional class III-IV symptoms at 12-months follow-up (OR 1.57; CI 95% 1.21–2.04; P < .001). Heterogeneity was low for all computations (I2 < 20%). Conclusion: Mortality following MitraClip implantation is similar for men and women. Men require implantation of >1 clip more frequently and are more likely to have NYHA III-IV symptoms 12-months after MitraClip implantation than women. Further research is needed to confirm these findings.
278 Comparing Measures to Assess Health-Related Quality of Life in Patients with Heartfailure with Preserved Ejection Fraction Rebecca Napier, Steven McNulty, David T. Eton, Margaret M. Redfield, Omar AbouEzzeddine, Shannon M. Dunlay; Mayo Clinic Rochester, Rochester, Minnesota Introduction: The ability to accurately assess health-related quality of life (HRQOL) in patients with heart failure (HF) is vital to clinical practice. The most widely accepted tools to assess HRQOL in HF are the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ). However, their validity and reliability have not been compared in patients with HF with preserved ejection fraction (HFpEF). Hypothesis: We hypothesized that the MLHFQ and KCCQ would both be reliable and valid in HFpEF, and the KCCQ would be more sensitive to changes in clinical status. Methods: We compared the reliability, validity, and responsiveness to change of the MLHFQ and KCCQ in chronic stable HFpEF patients enrolled in the Nitrate Effect on Activity Tolerance in Heart Failure trial (n = 110). Scores for the MLHFQ (range 0–105, higher = worse HRQOL) and KCCQ (range 0–100, higher = better HRQOL) and their subscales were calculated at baseline and 6 weeks. Internal consistency reliability was assessed using Cronbach’s α. The associations of MLHFQ and KCCQ with New York Heart Association (NYHA) functional class and 6 minute walk test (6MWT) at baseline were assessed using Spearman correlations (rs). Changes in MLHFQ and KCCQ from baseline to 6 weeks were compared with changes in the 6MWT using responsiveness statistics. Results: At baseline, the mean (standard deviation) MLHFQ total and KCCQ overall summary scores were 43.1 (24.6) and 56.1 (23.7). The proportions of participants with improvement (≥5 point improvement), no change, and decline (≥5 point worsening) in scores from baseline to 6 weeks were 55%, 28%, and 17% for the MLHFQ and 44%, 40%, and 16% for the KCCQ. Internal consistency was good to excellent (α ≥ 0.8) for both MLHFQ and five of six KCCQ domains at baseline and 6 weeks. Correlations with NYHA functional class and 6MWT were slightly stronger for the KCCQ summary score than the MLHFQ total score (Table). The MLHFQ total score was most responsive to improvements in 6MWT as indicated by changes in responsiveness statistics including effect size (Table). Conclusion: These data suggest that both the MLHFQ and KCCQ are reliable and valid tools to assess HRQOL in HFpEF. The KCCQ was more strongly correlated with baseline functional status parameters, while the MLHFQ was more responsive to improvement in 6MWT over time.
279 Sex-Specific Outcomes after MitraClip Implantation: A Systematic Review and Meta-Analysis Vanessa Blumer, Rodrigo Mendirichaga, Sandra Chaparro; University of Miami / Jackson Memorial Hospital, Miami, Florida Background: Women have worse long-term outcomes following mitral valve surgery for mitral regurgitation than men. Transcatheter edge-to-edge mitral valve repair with the use of MitraClip has been introduced as an alternative for patients with a prohibitivelyhigh surgical risk. Sex-specific data following MitraClip implantation presents conflicting results. Methods: We searched Medline, Embase, and Cochrane library from January 2005 to March 2017 for publications reporting sex-specific outcomes in patients undergoing MitraClip implantation. Outcomes were compared under the randomeffects model and heterogeneity examined via Chi2 and I2 statistics. Results: A total of 7 studies including 1798 patients undergoing MitraClip implantation (38% female) were included in the analysis. Acute device success rate and procedural complications were similar for both groups; however, men were more likely to require >1 clip (OR 0.52; CI 95% 0.39–0.69; P < .001). Mortality, hospital readmission, and residual MR ≥ 2 + after implantation were similar at 12-months. Men were more likely to report NYHA functional class III-IV symptoms at 12-months follow-up (OR 1.57; CI 95% 1.21–2.04; P < .001). Heterogeneity was low for all computations (I2 < 20%). Conclusion: Mortality following MitraClip implantation is similar for men and women. Men require implantation of >1 clip more frequently and are more likely to have NYHA III-IV symptoms 12-months after MitraClip implantation than women. Further research is needed to confirm these findings.