Long-Term Outcomes of Veteran Patients After Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become a mainstay treatment for severe aortic stenosis and is increasingly used for veterans, producing excellent short-term outcomes. There is a paucity of long-term outcome data after TAVR in the veteran population. METHODS: We examined consecutive patients who underwent TAVR at a single Veterans Affairs medical center through 2019. Baseline characteristics, echocardiographic and angiographic variables, and clinical outcomes were abstracted. All-cause mortality was the primary outcome of interest. Factors associated with all-cause mortality and cardiac-specific mortality, including the presence of significant non-revascularized coronary artery disease (CAD), were assessed with multivariable regression and competing-risk analyses. RESULTS: The 189 consecutive patients enrolled (mean age, 76.6 ± 8.4 years) had a median Society of Thoracic Surgeons (STS) score of 6.0 (interquartile range [IQR], 4.0-8.5). After a maximum follow-up of 7.5 years, 71 (37.6%) deaths occurred, of which 76% had a cardiac cause. Median overall survival was 3.55 years (95% confidence interval [CI], 3.21-5.30); significant graded differences were observed across STS risk subgroups (P<.001). After multivariable adjustment, CAD was significantly associated with cardiac mortality (hazard ratio [HR], 2.6; 95% CI, 1.3-5.3) and all-cause mortality (HR, 2.2; 95% CI, 1.1-4.3). Other independent variables associated with all-cause mortality included age (P=.01), baseline creatinine (P<.01), and chronic obstructive pulmonary disease (P=.03). Baseline ejection fraction (P=.04), age (P<.01), creatinine (P=.02), and vascular disease (P=.04) were independently associated with cardiac-specific mortality. CONCLUSION: Long-term survival of veterans after TAVR is comparable to that of their non-veteran counterparts. Significant CAD, along with age and select comorbidities, was associated with poorer survival.

Understanding by General Providers of the Echocardiogram Report.

Echocardiograms are the second most frequently utilized cardiac test after electrocardiograms and are most commonly ordered by noncardiology providers. Echocardiogram reports are designed to communicate a comprehensive interpretation of cardiac function; however, it is not known how well these reports are understood by ordering providers. In order to identify gaps in understanding and target potential areas for improvement, we developed a questionnaire testing various topics reported on a standard transthoracic echocardiogram report. This questionnaire was administered to general medicine and cardiology trainees and attending physicians at 2 large academic institutions. Questionnaire response rate was 81%. There were several topics that were not well understood by general providers; these included viability of an akinetic region, pulmonary artery systolic pressure, left ventricular filling pressure, recognition of abnormal structures, and method of identifying of intracardiac thrombus. In conclusion, strategies such as improved communication techniques and adjustment of reporting format should be implemented to increase the clinical value of the echocardiogram.

Aortic valve leaflet entrapment by a percutaneous closure device.

Iatrogenic aortic valve leaflet perforation and aorto-right atrial fistula are rare adverse events of transcatheter interventions and transseptal radiofrequency ablations, respectively. We present the case of a 62-year-old man who experienced acute, severe aortic insufficiency as a result of leaflet entrapment by a septal occluder device during attempted percutaneous closure of an iatrogenic aorto-right atrial fistula. This rare adverse event emphasizes the need for a thorough understanding of cardiac anatomy to minimize transcatheter adverse events and to recognize and treat them appropriately when they occur.

Early experience of a transcatheter aortic valve program at a Veterans Affairs facility.

IMPORTANCE: The US Food and Drug Administration recently approved the use of a transcatheter aortic valve in patients for whom traditional valve replacement surgery poses a high or prohibitive risk. Our hospital was one of the first Veterans Affairs facilities to launch a transcatheter aortic valve replacement (TAVR) program. OBJECTIVE: To evaluate our early experience with transfemoral TAVR. DESIGN AND SETTING: We retrospectively reviewed the records of all patients who underwent TAVR during the first year of our program at the Department of Cardiothoracic Surgery, Michael E. DeBakey Veterans Affairs Medical Center. PARTICIPANTS: The mean (SD) age of the patients was 77 (9) years, and their mean (SD) Society of Thoracic Surgeons predicted risk of mortality score was 8.8 (10.7). INTERVENTIONS: All patients underwent TAVR with the SAPIEN transcutaneous valve. MAIN OUTCOME MEASURES: We evaluated operative mortality and major operative morbidity (stroke, myocardial infarction, renal failure necessitating dialysis, and requirement for mechanical circulatory support, as well as vascular complications and requirement for permanent pacemaker), in addition to length of hospital stay and discharge status. RESULTS: Between December 21, 2011, and December 13, 2012, a total of 19 transfemoral TAVR procedures were performed at our center. Implantation was successful in all cases. There were no reports of operative (30-day) mortality, prosthetic valve endocarditis, renal failure necessitating dialysis, perioperative myocardial infarction or stroke, or conversion to surgical aortic valve replacement. Seven patients (37%) had mild paravalvular leak, 3 patients (16%) had moderate paravalvular leak, 2 patients (11%) had groin wound complications, 2 patients (11%) required a permanent pacemaker, 1 patient (5%) had a vascular access complication requiring endovascular repair, and 1 patient (5%) required temporary circulatory support (with extracorporeal membrane oxygenation). The mean (SD) length of hospital stay after TAVR was 8.0 (5.9) days. All patients were discharged home. CONCLUSIONS AND RELEVANCE: Transcatheter aortic valve replacement can be performed safely and with good outcomes at a Veterans Affairs facility with a committed multidisciplinary team and substantial experience in heart valve and endovascular therapies.

Bioprosthetic mitral valve endocarditis after percutaneous device closure of severe paravalvular leak.

A large mitral paravalvular leak in a 63-year-old patient was closed by percutaneous placement of 2 Amplatzer Septal Occluder (AGA Medical Corporation, Plymouth, MN) devices. The patient had a residual paravalvular leak and subsequently developed infective endocarditis that was successfully treated by removal of all hardware and implantation of a new valve. Transcatheter treatment of paravalvular leaks may be useful in select patients who are poor candidates for open surgery; however, one must be aware of the potential complications. This report underscores the risk of device infection that may be increased if there is turbulence related to residual paravalvular leaks.

The natural history of moderate aortic stenosis in a veteran population.

OBJECTIVE: Our objective was to evaluate the natural history of moderate aortic stenosis in veterans--a unique patient population with significant comorbidities. METHODS: We retrospectively reviewed the records of all patients who underwent echocardiography at a single veterans affairs hospital during 2006. We identified consecutive patients who had moderate aortic stenosis as indicated by a mean transaortic gradient of 25 to 40 mm Hg, peak aortic jet velocity of 3 to 4 m/s, or aortic valve area of 1.0 to 1.5 cm(2). The primary end point was defined as survival without aortic valve replacement. RESULTS: Of the 104 patients (mean age, 74 ± 10 years), 49% had diabetes, 21% had peripheral vascular disease, 21% were current smokers, 18% had chronic obstructive pulmonary disease, 60% had coronary artery disease, 89% had hypertension, and 31% had a body mass index of 30 kg/m(2) or more. Mean ejection fraction was 49% ± 12%. During the mean follow-up period of 22 months (range, 1-67 months), 30% of patients underwent aortic valve replacement--26% for symptomatic severe aortic stenosis and 4% concomitantly with coronary artery bypass grafting as the primary indicated operation--and 61% died. Event-free survivals were 48%, 24%, and 15% at 1, 3, and 5 years, respectively. CONCLUSIONS: Our cohort of military veteran patients had significant comorbidities. Event-free survival for such patients who have moderate aortic stenosis is significantly lower than previously reported data suggest. Within this unique group of patients, identifying factors that accelerate the progression of moderate aortic stenosis would help surgeons select patients who may benefit from early aortic valve replacement for moderate aortic stenosis.

Establishment of a transcatheter aortic valve program and heart valve team at a Veterans Affairs facility.

BACKGROUND: The US Food and Drug Administration recently approved a transcatheter aortic valve for patients for whom open heart surgery is prohibitively risky. METHODS: A multidisciplinary heart valve team partnered with administration to launch a transcatheter aortic valve replacement (TAVR) program. Clinical registries were used to show robust valve caseloads and outcomes at our Veterans Affairs (VA) facility and to project future volumes. A TAVR business plan was approved by the VA leadership as part of a multiphase project to upgrade and expand our surgical facilities. RESULTS: The heart valve team completed a training program that included simulations and visits to established TAVR centers. Patients were evaluated and screened through a streamlined process, and the program was initiated successfully. CONCLUSIONS: Establishing a TAVR program at a VA facility requires a multidisciplinary team with experience in heart valve and endovascular therapies and a supportive administration willing to invest in a sophisticated infrastructure.

Digoxin treatment in heart failure--unveiling risk by cluster analysis of DIG data.

BACKGROUND: Digoxin has been shown to reduce heart failure (HF) hospitalizations with no overall effect on mortality in HF patients. We used cluster analysis to delineate the clinical characteristics of HF patients in whom digoxin therapy was associated with improved or worsened clinical outcomes. METHODS: The Digitalis Investigation Group (DIG) database was partitioned into 20 clusters. Multivariate Cox regression analyses was used, to identify clusters in which digoxin was associated with either an increase (Mortality(dig)HR>1), decrease (Mortality(dig)HR<1), or no association with all cause mortality (Mortality(dig)HR-NS); and separately, with an increase (HFA(dig)HR>1), decrease (HFA(dig)HR<1), or no association (HFA(dig)HR-NS) with HF admissions (HFA). RESULTS: We identified 938 patients in the Mortality(dig)HR>1 group, 6818 patients in the Mortality(dig)HR-NS group, and none in Mortality(dig)HR<1 group. The Mortality(dig)HR>1 group had a higher prevalence of females, diabetes mellitus, hypertension, higher age, systolic blood pressure (SBP), heart rate and ejection fraction (EF), compared to the Mortality(dig)HR-NS group. Similarly, 6325 patients clustered in the HFA(dig)HR<1 group, 1431 patients in the HFA(dig)HR-NS group, and none in the HFA(dig)HR>1 group. The HFA(dig)HR-NS group had a higher prevalence of females and hypertension, higher SBP, body mass index and EF; and lower prevalence of peripheral edema and third heart sound, compared with the HFA(dig)HR<1 group. CONCLUSION: Thus, the baseline characteristics of patients who did not have reduction in HF hospitalization or who had increased mortality were very similar and included females with hypertension, higher EF and higher SBP. Thus, use of digoxin in patients with this profile may need to be avoided.

Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial.

OBJECTIVES: This paper describes the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial and its effect on risk factors. BACKGROUND: Most cardiovascular clinical trials test a single intervention. The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention in patients with stable coronary disease. METHODS: All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. RESULTS: The patients (n = 2,287) were followed for 4.6 years. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked >or=150 min/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 +/- 0.13 kg/m(2) to 29.3 +/- 0.23 kg/m(2) (p < 0.001). Appropriate medication use increased from pre-randomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; renin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 +/- 0.49 mm Hg to 123 +/- 0.88 mm Hg. Low-density lipoprotein cholesterol decreased from a median of 101 +/- 0.83 mg/dl to 72 +/- 0.88 mg/dl. CONCLUSIONS: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657).

Severe aortic stenosis in a veteran population: treatment considerations and survival.

BACKGROUND: We examined factors affecting the choice of surgical versus medical treatment of severe aortic stenosis and evaluated associated patient survival. METHODS: We retrospectively reviewed data from all patients diagnosed with severe aortic stenosis at a Veterans Affairs medical facility between January 1997 and April 2008. RESULTS: Of 345 patients with severe aortic stenosis, 260 (75%) underwent surgical evaluation, and 205 (59%) underwent aortic valve replacement (AVR). The patient's decision to decline surgical referral or AVR (n = 47) and severe comorbidities (n = 34) were the top two reasons for medical treatment rather than AVR. The AVR group was younger (69.5 +/- 9.6 years versus 75.7 +/- 8.6 years; p < 0.001) and had a higher prevalence of symptoms (96% versus 71%; p < 0.001) than the medical group. The medical group had a lower cardiac ejection fraction (0.42 +/- 0.15 versus 0.50 +/- 0.12; p < 0.001) and was less likely to be independent in activities of daily living (64% versus 74%). The AVR group had higher survival rates than the medical patients at 1 year (92% versus 65%), 3 years (85% versus 29%), and 5 years (73% versus 16%; log-rank test p < 0.0001). Valve replacement was independently associated with decreased mortality (hazard ratio, 0.17; 95% confidence interval, 0.10 to 0.27; p < 0.0001). CONCLUSIONS: The management of severe aortic stenosis in veterans is sometimes limited to medical evaluation and treatment. Surgeons should be involved in the complex process of risk assessment, to select patients with severe aortic stenosis who would benefit from the survival advantage associated with AVR.

Papillary fibroelastoma of the aortic valve: operative approaches upon incidental discovery.

Papillary fibroelastomas are the most common benign neoplasms of the cardiac valvular structures, and they are being recognized more frequently because of higher-resolution imaging technology. Papillary fibroelastomas are associated with substantial complications that are secondary to systemic embolism. Incidentally discovered papillary fibroelastomas are treated on the basis of their size, mobility, and associated comorbidities and symptoms. Surgical resection should be offered to all patients who have symptoms and to asymptomatic patients who have pedunculated lesions or tumors larger than 1 cm in diameter. Valve-sparing excision produces good long-term results in most instances.Herein, we present the case of a patient who was scheduled for elective myocardial revascularization and in whom an aortic valve papillary fibroelastoma was discovered incidentally during routine intraoperative transesophageal echocardiography. The timely recognition of this asymptomatic tumor enabled a modified operative approach: the patient underwent myocardial revascularization with concomitant valve-sparing resection of the tumor. We discuss the pathophysiology of fibroelastomas of the aortic valve and operative approaches to the management of these tumors when they are discovered incidentally.

Optimal medical therapy with or without PCI for stable coronary disease.

BACKGROUND: In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events. METHODS: We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6). RESULTS: There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33). CONCLUSIONS: As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).