Contemporary nationwide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter-directed thrombolysis for proximal deep venous thrombosis.

OBJECTIVE: Outflow venous stenting as an adjunct to catheter-directed thrombolysis (CDT) is performed to prevent recurrent thrombosis and to reduce the risk of post-thrombotic syndrome. Historical data show that stenting improves outcomes of surgical thrombectomy in patients with iliofemoral deep venous thrombosis (DVT), and recent observational data suggest that stenting improves long-term outcomes of CDT. However, the impact of stenting during CDT on acute safety outcomes is unknown. We sought to investigate the contemporary trends, safety outcomes, and resource utilization of adjunctive stent placement in patients undergoing CDT. METHODS: Patients with proximal lower extremity and caval DVT were identified within the National Inpatient Sample from January 2005 to December 2013. From this data set, we stratified our patients into three groups: patients who received CDT alone, patients who received CDT plus angioplasty, and patients who received CDT plus angioplasty with stenting. We used an inverse probability treatment weighting algorithm to create three weighted cohorts. Cochran-Armitage test was used to evaluate the trends of stent placement among patients treated with CDT. The primary outcome was a composite end point of all-cause mortality, gastrointestinal bleed, or intracranial hemorrhage. RESULTS: A total of 138,049 patients were discharged with a principal diagnosis of proximal and caval DVT; 7097 of these patients received CDT (5.1%). From this group, 2854 (40.2%) were treated with CDT alone, 2311 (32.6%) received adjunctive angioplasty alone, and 1932 (27.2%) received adjunctive angioplasty and stent. Adjunctive stenting had a significantly lower rate of primary composite outcome compared with CDT alone (2.7% vs 3.8%; P = .04). Stent placement was associated with a similar length of stay compared with angioplasty and CDT alone groups (6.8 vs 6.9 vs 7.1 days, respectively; P = .94) and higher in-hospital charges ($115,164.01 ± $76,985.31 vs $98,089.82 ± $72,921.94 vs $80,441.63 ± $74,024.98; P < .001). CONCLUSIONS: This nationwide study suggests that one in four patients undergoing CDT is treated with adjunctive stent placement in the United States. This observational study showed that adjunctive stenting does not adversely affect the acute safety outcomes of CDT; however, it was associated with increased hospital charges.

Predictors of intracranial hemorrhage in patients treated with catheter-directed thrombolysis for deep vein thrombosis.

BACKGROUND: Although acute intracranial hemorrhage (ICH) is a rare complication of catheter-directed thrombolysis (CDT), it remains a major concern associated with the use of CDT. The incidence and clinical predictors of developing ICH in the setting of CDT are not known. METHODS: The National Inpatient Sample database was used to identify all patients with proximal lower extremity or caval deep vein thrombosis (DVT) from January 2005 to December 2013 in the United States. Multivariate logistic regression was performed to identify the clinical predictors of ICH between patients with DVT who had received anticoagulation therapy alone and those who had been treated with CDT plus anticoagulation therapy. RESULTS: Of 138,049 patients with proximal lower extremity or caval DVT, 7119 (5.2%) had received anticoagulation therapy and CDT. Of the patients treated with anticoagulation alone, ICH had occurred in 0.2% compared with 0.7% for those treated with CDT (P < .01). The independent predictors of ICH in the CDT cohort were a history of stroke (odds ratio [OR], 19.4; 95% confidence interval [CI], 8.8-42.8; P < .01), chronic kidney disease (OR, 2.2; 95% CI, 1.1-4.7; P = .03), age >74 years (OR, 2.2; 95% CI, 1.2-4.3; P = .02), male sex (OR, 1.8; 95% CI, 1.01-3.3; P = .048). Of those patients treated with anticoagulation alone, the risk factors for the development of ICH were a history of stroke, hospital teaching status, and age >74 years. CONCLUSIONS: The results from the present nationwide observational study showed that of patients with DVT treated with CDT, the independent predictors for developing ICH were a history of stroke, chronic kidney disease, male sex, and age >74 years.

In-hospital outcomes of catheter-directed thrombolysis versus anticoagulation in cancer patients with proximal deep venous thrombosis.

OBJECTIVE: The objective of this study was to determine the rate of complications of catheter-directed thrombolysis (CDT) in cancer patients with deep venous thrombosis (DVT) compared with anticoagulation therapy alone. METHODS: This observational study used the National Inpatient Sample database to screen for any cancer patients who were admitted with a principal discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2013. Patients treated with CDT plus anticoagulation were compared with those treated with anticoagulation alone using propensity score matching for comorbidities and demographic characteristics. The primary end point was in-hospital mortality. Secondary end points were acute intracranial hemorrhage, inferior vena cava filter placement, acute renal failure, blood transfusion rates, length of stay, and hospital charges. RESULTS: We identified 31,124 cancer patients with lower extremity proximal or caval DVT, and 1290 (4%) patients were treated with CDT. Comparative outcomes as assessed in the two matched groups of 1297 patients showed that there was no significant difference in in-hospital mortality of patients undergoing CDT plus anticoagulation compared with those treated with anticoagulation alone (2.6% vs 1.9%; P = .23). However, CDT was associated with increased risk of intracranial hemorrhage (1.3% vs 0.4%; P = .017), greater blood transfusion rates (18.6% vs 13.1 %; P < .001), and higher rates of procedure-related hematoma (2.4% vs 0.4%; P < .001). The length of stay (6.0 [4.0-10.0] days vs 4.0 [2.0-7.0] days; P < .001) and hospital charges ($81,535 [$50,968-$127,045] vs $22,320 [$11,482-$41,005]; P < .001) were also higher in the CDT group compared with the control group. CONCLUSIONS: There was no significant difference in in-hospital mortality of cancer patients who underwent CDT plus anticoagulation compared with anticoagulation alone. CDT was associated with increased in-hospital morbidity and resource utilization compared with anticoagulation alone. Further studies are needed to examine the effect of CDT on the development of PTS in this population.

Prognostic Importance and Predictors of Survival in Isolated Tricuspid Regurgitation: A Growing Problem.

OBJECTIVE: To define mortality associated with isolated tricuspid regurgitation (TR) and identify risk factors associated with decreased survival. PATIENTS AND METHODS: We conducted a retrospective cohort study of residents of southeastern Minnesota with moderate-severe or more severe isolated TR diagnosed between January 1, 2005, and April 15, 2015. Isolated TR was defined as TR in the absence of left-sided heart disease or pulmonary hypertension. Patients with an ejection fraction of less than 50%, right ventricular systolic pressure greater than 45 mm Hg, moderate or more severe left-sided valve disease, congenital cardiac anomalies, previous valve operation, tricuspid stenosis, flail leaflet, carcinoid, and rheumatic disease were excluded. Five-year survival was compared with age- and sex-matched Minnesota census bureau data. Multivariate regression was used to identify variables associated with mortality. RESULTS: Over a 10-year period, 289 patients with isolated TR were identified. The mean ± SD age was 79.2±10.6 years, 70.6% (204) were women, atrial fibrillation was present in 74.0% (214), and 24.6% (71) had an intracardiac device. By 5 years after diagnosis, 51.5% had been hospitalized for heart failure. Observed 5-year mortality was 47.8% compared with 36.3% in the census data (P=.005). After adjusting for age and other comorbidities, multivariate regression identified a dilated inferior vena cava (≥2.1 cm) without respiratory variation on echocardiography (hazard ratio, 1.93; 95% CI, 1.13-3.31; P=.02) and creatinine level greater than 1.6 mg/dL (hazard ratio, 1.8; 95% CI, 1.16-2.8; P=.009) as associated with increased mortality. CONCLUSION: Patients with isolated TR are frequently hospitalized for heart failure and experience excess mortality. Elevated right atrial pressure and renal dysfunction are associated with mortality. This poor outcome may have implications for timing of intervention.

Prophylactic Inferior Vena Cava Filters Prior to Bariatric Surgery: Insights From the National Inpatient Sample.

OBJECTIVES: The aim of this study was to determine in-hospital mortality, post-surgical thromboembolic events, and health care costs associated with the placement of prophylactic inferior vena cava filters (IVCFs) prior to bariatric surgery. BACKGROUND: The role of prophylactic IVCFs prior to bariatric surgery is controversial, and the nationwide clinical outcomes associated with this practice are unknown. METHODS: This observational study used the National Inpatient Sample database to identify obese patients who underwent bariatric surgery from January 2005 to September 2015. Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among patients who did not receive IVCFs. RESULTS: A total of 258,480 patients underwent bariatric surgery, of whom 1,047 (0.41%) had prophylactic IVCFs implanted. Patients with prophylactic IVCFs compared with those without IVCFs had a significantly higher rate of the combined endpoint of in-hospital mortality or pulmonary embolism (1.4% vs. 0.4%; odds ratio: 3.75; 95% confidence interval [CI]: 1.25 to 11.30; p = 0.019). Additionally, prophylactic IVCFs were associated with higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%; odds ratio: 6.33; 95% CI: 1.87 to 21.4; p < 0.01), length of stay (median 3 days vs. 2 days; p < 0.01), and hospital charges (median $63,000 vs. $37,000; p < 0.01). CONCLUSIONS: In this nationwide observational study, prophylactic IVCF implantation prior to bariatric surgery was associated with worse clinical outcomes and increased health care resource utilization.

Catheter-based closure of aortic and mitral paravalvular leaks: existing techniques and new frontiers.

INTRODUCTION: Significant paravalvular leak (PVL) complicates between 6% and 15% of valve replacements and can result in heart failure and hemolysis. Paravalvular leak can be effectively treated with repeat surgery; however, these procedures are associated with significant operative morbidity. Percutaneous PVL closure is increasingly being utilized as the first line therapy for symptomatic patients, but efficacy may be limited by the lack of dedicated closure devices. AREAS COVERED: This article will review the etiology and prevalence of PVL, discuss outcomes with surgical closure, describe the mounting data supporting percutaneous interventions, and highlight areas for future research emphasizing the need for new dedicated closure devices. EXPERT COMMENTARY: Percutaneous PVL closure can be safely accomplished in the majority of patients with PVL thereby avoiding the risks associated with repeat surgical intervention. However, percutaneous interventions are associated with higher rates of persistent leakage in part due to off-label use of devices intended for other applications. Efforts to develop devices specifically intended for PVL closure are needed to further improve outcomes for percutaneous PVL closure.

Sex-stratified analysis of national trends and outcomes in isolated tricuspid valve surgery.

Objective: Female sex is a known risk factor for cardiac surgery, and tricuspid valve (TV) disease is more common in women. There are few data on sex-stratified surgical outcomes for isolated TV surgery. An administrative database was used to compare acute in-hospital outcomes between men and women undergoing isolated TV surgery. Methods: Patients aged >18 who underwent TV repair or replacement from 2004 to 2013 were identified using the National Inpatient Sample. Patients were excluded if they had congenital heart disease, endocarditis, or were undergoing concomitant cardiac surgeries except coronary bypass. Results were weighted to represent national averages. Sex-stratified analysis was performed using propensity score matching to compare in-hospital mortality, postoperative complications and hospital costs. Results: Over 10 years, women represented 58% of the 5005 TV surgeries performed. With propensity matching, hospital mortality (7.9% vs 7.7%; P=0.99) and median length of stay (11 vs 11 days; P=0.99) were similar between men and women. However, median hospital charges were higher for men ($166 000 vs $155 000; P=0.04). Conclusion: Isolated TV surgery is rare, but women more commonly undergo the procedure. In-hospital mortality was similar between men and women after propensity matching, but remains markedly high for both men and women in comparison to that reported for left-sided isolated valve surgery.

Isolated tricuspid regurgitation: outcomes and therapeutic interventions.

Isolated tricuspid regurgitation (TR) can be caused by primary valvular abnormalities such as flail leaflet or secondary annular dilation as is seen in atrial fibrillation, pulmonary hypertension and left heart disease. There is an increasing recognition of a subgroup of patients with isolated TR in the absence of other associated cardiac abnormalities. Left untreated isolated TR significantly worsens survival. Stand-alone surgery for isolated TR is rarely performed due to an average operative mortality of 8%-10% and a paucity of data demonstrating improved survival. When surgery is performed, valve repair may be preferred over replacement; however, there is a risk of significant recurrent regurgitation after repair. Existing society guidelines do not fully address the management of isolated TR. We propose that patients at low operative risk with symptomatic severe isolated TR and no reversible cause undergo surgery prior to the onset of right ventricular dysfunction and end-organ damage. For patients at increased surgical risk novel percutaneous interventions may offer an alternative treatment but further research is needed. Significant knowledge gaps remain and future research is needed to define operative outcomes and provide comparative data for medical and surgical therapy.

National Trends and Outcomes in Isolated Tricuspid Valve Surgery.

BACKGROUND: Severe isolated disease of the tricuspid valve (TV) is increasing and results in intractable right heart failure. However, isolated TV surgery is rarely performed, and there are little data describing surgical outcomes. OBJECTIVES: The purpose of this study was to evaluate contemporary utilization trends and in-hospital outcomes for isolated TV surgery in the United States. METHODS: Patients age >18 years who underwent TV repair or replacement from 2004 to 2013 were identified using the National Inpatient Sample. Patients with congenital heart disease, with endocarditis, and undergoing concomitant cardiac operations except for coronary bypass surgery were excluded. RESULTS: Over a 10-year period, a total of 5,005 isolated TV operations were performed nationally. Operations per year increased from 290 in 2004 to 780 in 2013 (p < 0.001 for trend). In-hospital mortality was 8.8% and did not vary across the study period. Adjusted in-hospital mortality for TV replacement was significantly higher than TV repair (odds ratio: 1.91; 95% confidence interval: 1.18 to 3.09; p = 0.009). CONCLUSIONS: Isolated TV surgery is rarely performed, although utilization has increased over time. However, despite an increase in surgical volume, operative mortality has not changed. Mortality is greatest in patients undergoing valve replacement. Given the increasing prevalence of isolated TV disease in the population, research into optimal surgical timing and patient selection is critical.

Transcatheter and Surgical Management of Mitral Paravalvular Leak: Long-Term Outcomes.

OBJECTIVES: The aim of this study was to report the use trends and immediate and long-term outcomes of a large cohort of patients who underwent redo surgery or transcatheter repair of paravalvular leaks (PVLs) at a tertiary referral center. BACKGROUND: Percutaneous treatment of mitral PVL has emerged as an alternative to surgical treatment in high-risk surgical candidates. There are limited data on the utilization trends, safety, and efficacy of both procedures in the management of mitral PVL. METHODS: Patients who underwent treatment of mitral PVL at the Mayo Clinic between January 1995 and December 2015 were enrolled. Utilization trends, procedural details, technical success, and in-hospital and long-term outcomes were assessed. RESULTS: Three hundred eighty-one patients underwent percutaneous (n = 195) or surgical (n = 186) treatment of mitral PVLs. The mean age was 66 ± 12 years, and 37% of patients had bioprosthetic valves. Technical success was higher in the surgical group (95.5% vs. 70.1%; p < 0.001). In-hospital major adverse events were more common after surgery (22.5% vs. 7.7%; p < 0.001). In-hospital death occurred in 3.1% and 8.6% of patients undergoing percutaneous and surgical treatment, respectively (p = 0.027). However, in a multivariate logistic regression analysis, only active endocarditis, chronic renal failure, and severe mitral annular calcifications were significant predictors of in-hospital mortality. Reintervention rates were similar (11.3% vs. 17.2% in the percutaneous and surgical groups, respectively; p = 0.10), with the majority of reinterventions in the percutaneous group occurring early because of residual leak or persistent hemolysis. After risk adjustment, there was no significant difference in long-term survival between patients who underwent surgical versus transcatheter treatment of PVLs. CONCLUSIONS: In contemporary practice, patients with symptomatic mitral PVLs are best treated with an integrated team approach incorporating both surgical and percutaneous techniques. Patient selection and timing of intervention are critical to achieve optimal results.

Sex Differences in the Utilization and Outcomes of Surgical Aortic Valve Replacement for Severe Aortic Stenosis.

BACKGROUND: Studies assessing the differential impact of sex on outcomes of aortic valve replacement (AVR) yielded conflicting results. We sought to investigate sex-related differences in AVR utilization, patient risk profile, and in-hospital outcomes using the Nationwide Inpatient Sample. METHODS AND RESULTS: In total, 166 809 patients (63% male and 37% female) who underwent AVR between 2003 and 2014 were identified, and 48.5% had a concomitant cardiac surgery procedure. Compared with men, women were older and had more nonatherosclerotic comorbid conditions including hypertension, diabetes mellitus, obstructive pulmonary disease, atrial fibrillation/flutter, and anemia but fewer incidences of coronary and peripheral arterial disease and prior sternotomies. In-hospital mortality was significantly higher in women (5.6% versus 4%, P<0.001). Propensity matching was performed to assess the impact of sex on the outcomes of isolated AVR and yielded 28 237 matched pairs of male and female participants. In the propensity-matched groups, in-hospital mortality was higher in women (3.3% versus 2.9%, P<0.001). Along with vascular complications and blood transfusion (6% versus 5.6%, P=0.027 and 40.4% versus 33.9%, P<0.001, respectively). Rates of stroke, permanent pacemaker implantation, and acute kidney injury requiring dialysis were similar (2.4% versus 2.4%, P=0.99; 6% versus 6.3%, P=0.15; and 1.4% versus 1.3%, P=0.14, respectively). Length of stay median and interquartile range were both similar between groups (7±6 days). Rates of nonhome discharge were higher among women (27.9% versus 19.6%, P<0.001). CONCLUSIONS: Women have worse in-hospital mortality following AVR compared with men. Coupled with the accumulating evidence suggesting higher magnitude of benefit of transcatheter AVR over AVR in women, women should perhaps be offered transcatheter AVR over AVR at a lower threshold than men.

Characteristics and outcomes of re-do percutaneous paravalvular leak closure.

BACKGROUND: Percutaneous paravalvular leak (PVL) closure is an alternative treatment option for severely symptomatic, high-surgical risk patients with PVL. Some patients require multiple percutaneous PVL closure procedures. However, the procedural characteristics and success rate of re-do PVL closure have not been well studied. AIMS: The aim of this study is to investigate the indications, procedural characteristics, technical success rate, and 30-day major adverse cardiovascular events (MACE) in patients who underwent re-do PVL closure. METHODS: Consecutive patients who underwent percutaneous paramitral or paraaortic leak closure at Mayo Clinic, Rochester, Minnesota from 2004 through 2015 were studied. Clinical and procedural characteristics of patients who underwent re-do PVL closure were compared to age- and sex-matched patients who underwent their first percutaneous PVL closure. Procedure success and 30-day MACE were compared in both the groups. RESULTS: Among 223 identified percutaneous PVL closures, 16 (7%) were re-do procedures. Patients who underwent re-do PVL closure were predominantly men (87.5%) with a mean age of 68 ± 15 years and an estimated mean Society of Thoracic Surgery (STS) 30-day mortality of 4.6 ± 2.8. Half of the re-do PVL closures were performed on mechanical valves and 62.5% were performed on paramitral defects. Indications for re-do PVL closure were: (1) emergence of new significant paravalvular defects in 50%, (2) incomplete index defect closure in 43.75%, and (3) index procedural complication in 6.25% of the cases. Procedural success was 75% in re-do procedures vs. 85.4% in age- and sex-matched control group (P = 0.45). Thirty-day MACE was 12.5% in the re-do group compared to 4.2% in the age- and-sex matched patients who underwent PVL closure for the first time (P = 0.35). CONCLUSION: Re-do percutaneous PVL closure is feasible with favorable procedural success rate and low 30-day MACE. Development of new paravalvular defects is the most common indication for re-do PVL closure, highlighting the importance of careful longitudinal monitoring and follow-up. © 2017 Wiley Periodicals, Inc.