Cardiology

Posted February 15th 2017

Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population: A Report From the STS/ACC Transcatheter Valve Therapy Registry.

Michael J. Mack M.D.

Michael J. Mack M.D.

Arnold, S. V., J. A. Spertus, S. Vemulapalli, Z. Li, R. A. Matsouaka, S. J. Baron, A. N. Vora, M. J. Mack, M. R. Reynolds, J. S. Rumsfeld and D. J. Cohen (2017). “Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report from the sts/acc transcatheter valve therapy registry.” JAMA Cardiol: 2017 Feb [Epub ahead of print].

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Importance: In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance. Objective: To examine the short- and long-term health status outcomes of surviving patients after TAVR in the context of an unselected population. Design, Setting, and Participants: This observational cohort study included patients with severe aortic stenosis who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016, at more than 450 clinical sites. Main Outcomes and Measures: Disease-specific health status was assessed at baseline and at 30 days and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score (range, 0-100 points; higher scores indicate less symptom burden and better quality of life). Factors associated with health status at 1 year after TAVR were examined using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results: The 30-day analytic sample included 31 636 patients, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men [50.8%]; median [interquartile range] age, 84 [78-88] years). The mean (SD) baseline KCCQ-OS score was 42.3 (23.7), indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, prior stroke, diabetes, pacemaker use, atrial fibrillation, slow gait speed, and nonfemoral access were significantly associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS score, >/=60] and no significant decline [>/=10 points] from baseline), with the lowest rates seen among patients with severe lung disease (51.4%), those undergoing dialysis (47.7%), or those with very poor baseline health status (49.2%). Conclusions and Relevance: In a national, contemporary clinical practice cohort of unselected patients, improvement in health status after TAVR was similar to that seen in the pivotal clinical trials. Although the health status results were favorable for most patients, approximately 1 in 3 still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural/postprocedural care to maximize health status outcomes of this evolving therapy.


Posted February 15th 2017

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.

Michael J. Mack M.D.

Michael J. Mack M.D.

Arsalan, M., J. J. Squiers, M. A. Herbert, J. C. MacHannaford, T. Chamogeorgakis, S. L. Prince, B. L. Hamman, C. Knoff, D. O. Moore, K. B. Harrington, J. M. DiMaio, M. J. Mack and W. T. Brinkman (2017). “Comparison of outcomes of operative therapy for acute type a aortic dissections provided at high-volume versus low-volume medical centers in north texas.” Am J Cardiol 119(2): 323-327.

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Immediate surgery is standard therapy for acute type A aortic dissections (TAAD). Because of its low incidence, many smaller cardiac surgery programs do not routinely perform this procedure because it may negatively affect outcomes. Many high-risk, low-volume (LV) surgical procedures are now preferentially performed in reference centers. We compared the outcomes of surgery for TAAD in high-volume (HV) and LV centers in a single metropolitan area to determine the optimal setting for treatment. Thirty-five of the 37 cardiac surgery programs in the Dallas Ft. Worth metropolitan area participate in a regional consortium to measure outcomes collected in the Society of Thoracic Surgeons Adult Cardiac Database. From January 01, 2008, to December 31, 2014, 29 programs had treated TAAD. Those programs performing at least 100 operations for TAAD were considered HV centers and the others LV. Surgery for TAAD was performed in 672 patients over the 7-year study period with HV centers performing 469 of 672 (70%) of the operations. Despite similar preoperative characteristics, operative mortality was significantly lower in HV versus LV centers (14.1% vs 24.1%; p = 0.001). There was no significant difference in postoperative paralysis rates (2.6% vs 4.5%; p = 0.196), stroke rates (10.7% vs 9.4%; p = 0.623), or 30-day readmission rates (12.1% vs 15.5%; p = 0.292). An improved survival rate in HV centers was maintained over a 5-year follow-up period. Surgery for TAAD in a single large metropolitan area was most commonly performed in HV centers. In conclusion, the treatment of acute thoracic aortic dissection is recommended to be performed in reference centers because of lower early and midterm mortality.


Posted February 15th 2017

Comparison of Outcomes of Operative Therapy for Acute Type A Aortic Dissections Provided at High-Volume Versus Low-Volume Medical Centers in North Texas.

William Brinkman M.D.

William Brinkman M.D.

Arsalan, M., J. J. Squiers, M. A. Herbert, J. C. MacHannaford, T. Chamogeorgakis, S. L. Prince, B. L. Hamman, C. Knoff, D. O. Moore, K. B. Harrington, J. M. DiMaio, M. J. Mack and W. T. Brinkman (2017). “Comparison of outcomes of operative therapy for acute type a aortic dissections provided at high-volume versus low-volume medical centers in north texas.” Am J Cardiol 119(2): 323-327.

Full text of this article.

Immediate surgery is standard therapy for acute type A aortic dissections (TAAD). Because of its low incidence, many smaller cardiac surgery programs do not routinely perform this procedure because it may negatively affect outcomes. Many high-risk, low-volume (LV) surgical procedures are now preferentially performed in reference centers. We compared the outcomes of surgery for TAAD in high-volume (HV) and LV centers in a single metropolitan area to determine the optimal setting for treatment. Thirty-five of the 37 cardiac surgery programs in the Dallas Ft. Worth metropolitan area participate in a regional consortium to measure outcomes collected in the Society of Thoracic Surgeons Adult Cardiac Database. From January 01, 2008, to December 31, 2014, 29 programs had treated TAAD. Those programs performing at least 100 operations for TAAD were considered HV centers and the others LV. Surgery for TAAD was performed in 672 patients over the 7-year study period with HV centers performing 469 of 672 (70%) of the operations. Despite similar preoperative characteristics, operative mortality was significantly lower in HV versus LV centers (14.1% vs 24.1%; p = 0.001). There was no significant difference in postoperative paralysis rates (2.6% vs 4.5%; p = 0.196), stroke rates (10.7% vs 9.4%; p = 0.623), or 30-day readmission rates (12.1% vs 15.5%; p = 0.292). An improved survival rate in HV centers was maintained over a 5-year follow-up period. Surgery for TAAD in a single large metropolitan area was most commonly performed in HV centers. In conclusion, the treatment of acute thoracic aortic dissection is recommended to be performed in reference centers because of lower early and midterm mortality.


Posted February 15th 2017

Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (LCZ696) in patients with chronic heart failure and reduced ejection fraction: results from PARADIGM-HF.

Milton Packer M.D.

Milton Packer M.D.

Bohm, M., R. Young, P. S. Jhund, S. D. Solomon, J. Gong, M. P. Lefkowitz, A. R. Rizkala, J. L. Rouleau, V. C. Shi, K. Swedberg, M. R. Zile, M. Packer and J. J. McMurray (2017). “Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (lcz696) in patients with chronic heart failure and reduced ejection fraction: Results from paradigm-hf.” Eur Heart J: 2017 Feb [Epub ahead of print].

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Background: Compared to heart failure patients with higher systolic blood pressure (SBP), those with lower SBP have a worse prognosis. To make matters worse, the latter patients often do not receive treatment with life-saving therapies that might lower blood pressure further. We examined the association between SBP and outcomes in the Prospective Comparison of angiotensin receptor-neprilysin inhibitor (ARNI) with an angiotensin-converting enzyme (ACE) inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure trial (PARADIGM-HF), as well as the effect of sacubitril/valsartan, compared with enalapril, according to baseline SBP. Methods: We analysed the effect of treatment on SBP and on the primary composite outcome (cardiovascular death or heart failure hospitalization), its components and all-cause death. We examined baseline SBP as a categorical (<110, 110 to < 120, 120 to < 130, 130 to < 140 and ≥140 mmHg) and continuous variable, as well as average in-trial SBP and time-updated SBP. Findings: All-cause and cardiovascular mortality rates were highest in patients with the lowest SBP whereas there was a U-shaped relationship between SBP and the rate of heart failure hospitalization. The benefit of sacubitril/valsartan over enalapril was consistent across all baseline SBP categories for all outcomes. For example, the sacubitril/valsartan versus enalapril hazard ratio for the primary endpoint was 0.88 (95%CI 0.74–1.06) in patients with a baseline SBP <110 mmHg and 0.81 (0.65–1.02) for those with a SBP ≥140 mmHg (P for interaction = 0.55). Symptomatic hypotension, study drug dose-reduction and discontinuation were more frequent in patients with a lower SBP. Interpretation: In PARADIGM-HF, patients with lower SBP at randomization, notably after tolerating full doses of both study drugs during a run-in period, were at higher risk but generally tolerated sacubitril/valsartan and had the same relative benefit over enalapril as patients with higher baseline SBP.


Posted February 15th 2017

Case report: whole exome sequencing of primary cardiac angiosarcoma highlights potential for targeted therapies.

William C. Roberts M.D.

William C. Roberts M.D.

Zhrebker, L., I. Cherni, L. M. Gross, M. M. Hinshelwood, M. Reese, J. Aldrich, J. M. Guileyardo, W. C. Roberts, D. Craig, D. D. Von Hoff, R. G. Mennel and J. D. Carpten (2017). “Case report: Whole exome sequencing of primary cardiac angiosarcoma highlights potential for targeted therapies.” BMC Cancer 17(1): 17-eoa.

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BACKGROUND: Primary cardiac angiosarcomas are rare, but they are the most aggressive type of primary cardiac neoplasms. When patients do present, it is with advanced pulmonary and/or cardiac symptoms. Therefore, many times the correct diagnosis is not made at the time of initial presentation. These patients have metastatic disease and the vast majority of these patients die within a few months after diagnosis. Currently the treatment choices are limited and there are no targeted therapies available. CASE PRESENTATION: A 56-year-old male presented with shortness of breath, night sweats, and productive cough for a month. Workup revealed pericardial effusion and multiple bilateral pulmonary nodules suspicious for metastatic disease. Transthoracic echocardiogram showed a large pericardial effusion and a large mass in the base of the right atrium. Results of biopsy of bilateral lung nodules established a diagnosis of primary cardiac angiosarcoma. Aggressive pulmonary disease caused rapid deterioration; the patient went on hospice and subsequently died. Whole exome sequencing of the patient’s postmortem tumor revealed a novel KDR (G681R) mutation, and focal high-level amplification at chromosome 1q encompassing MDM4, a negative regulator of TP53. CONCLUSION: Mutations in KDR have been reported previously in angiosarcomas. Previous studies also demonstrated that KDR mutants with constitutive KDR activation could be inhibited with specific KDR inhibitors in vitro. Thus, patients harboring activating KDR mutations could be candidates for treatment with KDR-specific inhibitors.