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Transcatheter Mitral Valve Repair in Patients with Functional Mitral Regurgitation—One-Year Outcomes From the Multicenter CE Trial
830 Journal of Cardiac Failure Vol. 23 No. 11 November 2017
Late Breaking Clinical Trial Abstracts From HFSA 2017 Transcatheter Mitral Valve Repair in Patients with Functional Mitral Regurgitation—One-Year Outcomes From the Multicenter CE Trial William Abraham1, Alec Vahanian2, Ottavio Alfieri3, Antonio Colombo3, Karl-Heinz Kuck4, Stephan Baldus5, Francesco Maisano6, Jörg Hausleiter7, Arthur Kerner8, Corrado Tamburino9, J.A.S. van der Heyden10, Ralph Stephan von Bardeleben11, Georg Nickenig12; 1 The Ohio State University, Columbus, Ohio; 2Bichat Hospital, Paris, France; 3San Raffaele Hospital, Milan, Italy; 4St. George Hospital, Hamburg, Germany; 5University Hospital Cologne, Germany; 6University Hospital Zurich, Switzerland; 7LudwigMaximilians University Hospital Munich, Germany; 8Rambam Health Care Campus, Israel; 9Policlinico Vittorio Emanuele University Hospital, University of Catania, Italy; 10 St. Antonius Hospital, The Netherlands; 11University Medical Center Mainz, Germany; 12 University Hospital Bonn, Germany Aims: The aim of this multicenter study was to evaluate the feasibility, safety and outcomes up to 12 months of the Edwards Cardioband transcatheter mitral valve repair system in the treatment of patients with secondary mitral regurgitation (MR). Methods and Results: Between February 2013 and June 2016, 61 patients at high risk for surgery with significant secondary MR were enrolled at 11 European sites. All patients were screened by a heart team using echocardiography and cardiac CT. Mean patient age was 72 ± 7 years, 44 were males (72%). Mean EuroSCORE II was 7.1%. At baseline, 53 patients (87%) were in NYHA functional class III-IV, with a mean left ventricular ejection fraction of 33 ± 11%. The implant success rate was 98% and the device success rate 80%. After implant size adjustment, an average 28% reduction in septolateral mitral annular diameter was observed (from 37 ± 4 mm to 26 ± 4 mm; P < .01). At one month follow-up, two patients died from non-device related causes. 87% of patients had MR ≤ 2 + as assessed by independent core lab. One year follow-up is available for 38 patients and shows that 79% of patients are in NYHA class I/II, with an average 21 points improvement in Minnesota Living with Heart Failure Questionnaire scores and an average increase of 63 meters in 6-minute walk distance. MR ≤ 2 + was demonstrated in 94% of patients at one year. Conclusions: These results show that transcatheter mitral valve repair using the Edwards Cardioband system is feasible and safe and provides a clinically significant reduction in MR grade. The favorable acute clinical and hemodynamic results are maintained up to one year. In addition this new treatment leaves options open for future interventions for patients with functional mitral regurgitation. Effect of Natriuretic Peptide-Guided Therapy on Outcomes in High-Risk Patients with Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial G. Michael Felker1, Kevin J. Anstrom1, Kirkwood F. Adams2, Justin A. Ezekowitz3, Mona Fiuzat1, Nancy Houston-Miller4, James L. Januzzi Jr.5, Daniel B. Mark1, Ileana L. Piña6, Gayle Passmore1, David J. Whellan7, Hongqiu Yang1, Lawton S. Cooper8, Eric S. Leifer8, Patrice Desvigne-Nickens8, Christopher M. O’Connor1,9; 1Duke Clinical Research Institute, Durham, North Carolina; 2University of North Carolina- Chapel Hill, Chapel Hill, North Carolina; 3Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada; 4The LifeCare Company, Menlo Park, California; 5Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts; 6Albert Einstein College of Medicine, Bronx, New York; 7Thomas Jefferson University, Philadelphia, Pennsylvania; 8Division of Cardiovascular Sciences, National Heart Lung and Blood Institute, Bethesda, Maryland; 9Inova Heart and Vascular Center, Fairfax, Virginia Introduction: The natriuretic peptides, specifically B-type natriuretic peptide (BNP) and aminoterminal pro–B-type natriuretic peptide (NT-proBNP), are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels (“guided therapy”) with inconsistent results. Hypothesis: A strategy of NT-proBNPguided treatment improves clinical outcomes compared to usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). Methods: The GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multi-center clinical trial conducted between January 2013 and December 2016 at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNPguided strategy or usual care. Patients were randomized to either an NT-proBNPguided strategy or usual care. Patients randomized to the guided strategy had HF therapy titrated with the goal of achieving a target NT-proBNP <1000 pg/mL. Patients randomized to usual had heart failure care in accordance with published guidelines. The primary endpoint was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary endpoints included all-cause mortality, total hospitalizations fr HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary endpoint, and safety. Results: The Data and Safety Monitoring Board recommended stopping the study for futility when 894 of the planned 1100 patients had been enrolled and followed for a median of 15 months. The primary endpoint occurred in 164 patients (37%) in the biomarker-guided group and 164 patients (37%) in the usual care group (adjusted hazard ratio = 0.98; 95% confidence interval 0.79–1.22; P = .88). Cardiovascular mortality was 12% in the biomarker guided group and 13% in the usual care group (hazard ratio = 0.94; 95% confidence interval 0.65–1.37, P = .75). Neither other secondary endpoints nor achieved decreases in NT-proBNP levels were significantly different
between the groups. Conclusions: In high-risk patients with HFrEF, a strategy of NT-proBNP-guided therapy was not more effective than a usual care strategy in improving outcomes.
Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure (GOURMETHF) Pilot Randomized Trial: Primary Results Scott L. Hummel1,2, Wahida Karmally3, Brenda W. Gillespie1, Stephen T. Helmke3, Sergio Teruya3, Jeffrey D. Wessler3, Joanna M. Wells1, Omar Jimenez3, Erika Trumble2, Maria Cornellier1, Cara Marolt1, Mathew S. Maurer3; 1University of Michigan, Ann Arbor, Michigan; 2Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan; 3Columbia University Medical Center, New York, New York Introduction: In patients with heart failure (HF), malnutrition and excess dietary sodium intake are common and may worsen outcomes. However, some studies suggest no benefit or even harm related to dietary sodium restriction in HF. No previous studies have examined the effects of providing low-sodium, nutritionally-complete meals following discharge from HF hospitalization. Hypothesis and Outcomes: Compared with usual care, home meal delivery of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating pattern will improve HFrelated quality of life at 4 weeks post-discharge from HF hospitalization. In addition to safety monitoring and clinical event reporting, additional data collected in the study include changes in cardiac and inflammatory biomarkers, cardiac and vascular function, micronutrient levels, and salt taste affinity. Methods: GOURMET-HF is a three-site, single-blind, randomized controlled pilot trial (NCT02148679) in patients admitted for acutely decompensated HF with previous history of hypertension. Participants were randomized at hospital discharge to home-delivered DASH/SRD (1500 mg sodium/day) vs. usual care. The primary study outcome is the between-group change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score from baseline to 4 weeks post-discharge. The main exclusion criteria were symptomatic hypotension, hyperkalemia, and severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2). Key clinical outcomes include death/allcause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). Additional outcomes include change in KCCQ sub-domains, including the Clinical Summary Score (average of Physical Limitation and Total Symptom scores), and general quality of life (SF-12, Visual Analog Scale). Paired t-testing was used for within-group and ANCOVA, 2-sample t-testing, chisquare, or Fisher’s exact test were used as appropriate for between-group comparisons. Results: Of 107 enrolled participants, 66 met criteria at hospital discharge and were randomized 1:1 to DASH/SRD vs. usual care (age 71 ± 8 years, 30% female, 30% African-American, 36% Hispanic, 56% diabetes mellitus, body mass index 32.6 ± 7.7 kg/m2, ejection fraction 39 ± 18%, eGFR 54 ± 17). The HF-related quality of life increased in both groups at 4 weeks; general quality of life did not change. The change in KCCQ Summary Score did not differ between groups, but KCCQ Clinical Summary Score improved to a greater degree in the DASH/SRD group (Figure). Potentially diet-related adverse events were numerically more common, but 30-day readmissions and days hospitalized trended lower in the DASH/SRD group (Table). Conclusions: Home-delivered DASH/SRD immediately following HF hospitalization appeared safe in selected patients, and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to determine the effects of post-discharge dietary support on functional status and readmission rate in patients with HF.
Figure. KCCQ Summary and Clinical Summary Scores
Late Breaking Clinical Trial Abstracts From HFSA 2017 Transcatheter Mitral Valve Repair in Patients with Functional Mitral Regurgitation—One-Year Outcomes From the Multicenter CE Trial William Abraham1, Alec Vahanian2, Ottavio Alfieri3, Antonio Colombo3, Karl-Heinz Kuck4, Stephan Baldus5, Francesco Maisano6, Jörg Hausleiter7, Arthur Kerner8, Corrado Tamburino9, J.A.S. van der Heyden10, Ralph Stephan von Bardeleben11, Georg Nickenig12; 1 The Ohio State University, Columbus, Ohio; 2Bichat Hospital, Paris, France; 3San Raffaele Hospital, Milan, Italy; 4St. George Hospital, Hamburg, Germany; 5University Hospital Cologne, Germany; 6University Hospital Zurich, Switzerland; 7LudwigMaximilians University Hospital Munich, Germany; 8Rambam Health Care Campus, Israel; 9Policlinico Vittorio Emanuele University Hospital, University of Catania, Italy; 10 St. Antonius Hospital, The Netherlands; 11University Medical Center Mainz, Germany; 12 University Hospital Bonn, Germany Aims: The aim of this multicenter study was to evaluate the feasibility, safety and outcomes up to 12 months of the Edwards Cardioband transcatheter mitral valve repair system in the treatment of patients with secondary mitral regurgitation (MR). Methods and Results: Between February 2013 and June 2016, 61 patients at high risk for surgery with significant secondary MR were enrolled at 11 European sites. All patients were screened by a heart team using echocardiography and cardiac CT. Mean patient age was 72 ± 7 years, 44 were males (72%). Mean EuroSCORE II was 7.1%. At baseline, 53 patients (87%) were in NYHA functional class III-IV, with a mean left ventricular ejection fraction of 33 ± 11%. The implant success rate was 98% and the device success rate 80%. After implant size adjustment, an average 28% reduction in septolateral mitral annular diameter was observed (from 37 ± 4 mm to 26 ± 4 mm; P < .01). At one month follow-up, two patients died from non-device related causes. 87% of patients had MR ≤ 2 + as assessed by independent core lab. One year follow-up is available for 38 patients and shows that 79% of patients are in NYHA class I/II, with an average 21 points improvement in Minnesota Living with Heart Failure Questionnaire scores and an average increase of 63 meters in 6-minute walk distance. MR ≤ 2 + was demonstrated in 94% of patients at one year. Conclusions: These results show that transcatheter mitral valve repair using the Edwards Cardioband system is feasible and safe and provides a clinically significant reduction in MR grade. The favorable acute clinical and hemodynamic results are maintained up to one year. In addition this new treatment leaves options open for future interventions for patients with functional mitral regurgitation. Effect of Natriuretic Peptide-Guided Therapy on Outcomes in High-Risk Patients with Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial G. Michael Felker1, Kevin J. Anstrom1, Kirkwood F. Adams2, Justin A. Ezekowitz3, Mona Fiuzat1, Nancy Houston-Miller4, James L. Januzzi Jr.5, Daniel B. Mark1, Ileana L. Piña6, Gayle Passmore1, David J. Whellan7, Hongqiu Yang1, Lawton S. Cooper8, Eric S. Leifer8, Patrice Desvigne-Nickens8, Christopher M. O’Connor1,9; 1Duke Clinical Research Institute, Durham, North Carolina; 2University of North Carolina- Chapel Hill, Chapel Hill, North Carolina; 3Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada; 4The LifeCare Company, Menlo Park, California; 5Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts; 6Albert Einstein College of Medicine, Bronx, New York; 7Thomas Jefferson University, Philadelphia, Pennsylvania; 8Division of Cardiovascular Sciences, National Heart Lung and Blood Institute, Bethesda, Maryland; 9Inova Heart and Vascular Center, Fairfax, Virginia Introduction: The natriuretic peptides, specifically B-type natriuretic peptide (BNP) and aminoterminal pro–B-type natriuretic peptide (NT-proBNP), are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels (“guided therapy”) with inconsistent results. Hypothesis: A strategy of NT-proBNPguided treatment improves clinical outcomes compared to usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). Methods: The GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multi-center clinical trial conducted between January 2013 and December 2016 at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNPguided strategy or usual care. Patients were randomized to either an NT-proBNPguided strategy or usual care. Patients randomized to the guided strategy had HF therapy titrated with the goal of achieving a target NT-proBNP <1000 pg/mL. Patients randomized to usual had heart failure care in accordance with published guidelines. The primary endpoint was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary endpoints included all-cause mortality, total hospitalizations fr HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary endpoint, and safety. Results: The Data and Safety Monitoring Board recommended stopping the study for futility when 894 of the planned 1100 patients had been enrolled and followed for a median of 15 months. The primary endpoint occurred in 164 patients (37%) in the biomarker-guided group and 164 patients (37%) in the usual care group (adjusted hazard ratio = 0.98; 95% confidence interval 0.79–1.22; P = .88). Cardiovascular mortality was 12% in the biomarker guided group and 13% in the usual care group (hazard ratio = 0.94; 95% confidence interval 0.65–1.37, P = .75). Neither other secondary endpoints nor achieved decreases in NT-proBNP levels were significantly different
between the groups. Conclusions: In high-risk patients with HFrEF, a strategy of NT-proBNP-guided therapy was not more effective than a usual care strategy in improving outcomes.
Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure (GOURMETHF) Pilot Randomized Trial: Primary Results Scott L. Hummel1,2, Wahida Karmally3, Brenda W. Gillespie1, Stephen T. Helmke3, Sergio Teruya3, Jeffrey D. Wessler3, Joanna M. Wells1, Omar Jimenez3, Erika Trumble2, Maria Cornellier1, Cara Marolt1, Mathew S. Maurer3; 1University of Michigan, Ann Arbor, Michigan; 2Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan; 3Columbia University Medical Center, New York, New York Introduction: In patients with heart failure (HF), malnutrition and excess dietary sodium intake are common and may worsen outcomes. However, some studies suggest no benefit or even harm related to dietary sodium restriction in HF. No previous studies have examined the effects of providing low-sodium, nutritionally-complete meals following discharge from HF hospitalization. Hypothesis and Outcomes: Compared with usual care, home meal delivery of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating pattern will improve HFrelated quality of life at 4 weeks post-discharge from HF hospitalization. In addition to safety monitoring and clinical event reporting, additional data collected in the study include changes in cardiac and inflammatory biomarkers, cardiac and vascular function, micronutrient levels, and salt taste affinity. Methods: GOURMET-HF is a three-site, single-blind, randomized controlled pilot trial (NCT02148679) in patients admitted for acutely decompensated HF with previous history of hypertension. Participants were randomized at hospital discharge to home-delivered DASH/SRD (1500 mg sodium/day) vs. usual care. The primary study outcome is the between-group change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score from baseline to 4 weeks post-discharge. The main exclusion criteria were symptomatic hypotension, hyperkalemia, and severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2). Key clinical outcomes include death/allcause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). Additional outcomes include change in KCCQ sub-domains, including the Clinical Summary Score (average of Physical Limitation and Total Symptom scores), and general quality of life (SF-12, Visual Analog Scale). Paired t-testing was used for within-group and ANCOVA, 2-sample t-testing, chisquare, or Fisher’s exact test were used as appropriate for between-group comparisons. Results: Of 107 enrolled participants, 66 met criteria at hospital discharge and were randomized 1:1 to DASH/SRD vs. usual care (age 71 ± 8 years, 30% female, 30% African-American, 36% Hispanic, 56% diabetes mellitus, body mass index 32.6 ± 7.7 kg/m2, ejection fraction 39 ± 18%, eGFR 54 ± 17). The HF-related quality of life increased in both groups at 4 weeks; general quality of life did not change. The change in KCCQ Summary Score did not differ between groups, but KCCQ Clinical Summary Score improved to a greater degree in the DASH/SRD group (Figure). Potentially diet-related adverse events were numerically more common, but 30-day readmissions and days hospitalized trended lower in the DASH/SRD group (Table). Conclusions: Home-delivered DASH/SRD immediately following HF hospitalization appeared safe in selected patients, and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to determine the effects of post-discharge dietary support on functional status and readmission rate in patients with HF.
Figure. KCCQ Summary and Clinical Summary Scores