Time From First Contact With Heart Team to Transcatheter Aortic Valve Replacement in the COVID-19 Era.

OBJECTIVE: Transcatheter aortic valve replacement (TAVR) has become the dominant form of aortic valve replacement in the United States. During the Coronavirus disease 2019 (COVID-19) pandemic, access to elective surgical care was decreased, particularly for TAVR patients. In this study, we examine the impact of each COVID-19 "wave," on our patient's access to TAVR procedures and their associated outcomes.  Methods: After institutional review board approval, we conducted a retrospective review of a prospectively maintained database and a review of our own center's database to assess time to TAVR pre-COVID-19 and during internally defined COVID-19 "waves." Statistical analysis was conducted via a t-test. RESULTS: We measured the time from first contact to TAVR and compared each COVID-19 wave to our institution's pre-COVID-19 data. During Wave 1 and 2 of COVID-19, our mean time to TAVR increased significantly to 68.44 ± 48.66 days (p = 0.05) and 68.94 ± 53.16 days (p = 0.02), respectively. All three COVID-19 waves demonstrated a statistically significant increase in all-cause mortality post-operatively (PO) with mean PO mortality of 2.5 (p = 0.0035), 1.33 (p = 0.0009), and 0.67 (p = 0.006), respectively, compared to pre-COVID-19 data.  Conclusions: Multiple studies have shown that increased time from first contact to TAVR results in increased morbidity and mortality. COVID-19 increased our institution's time to TAVR significantly across two waves with an increase in all-cause mortality in each wave. This study highlights the importance that institutions should develop mechanisms to ensure access to care during crises so that patients do not face potentially avoidable harm.

Postoperative chemotherapy and radiation improve survival following cardiac sarcoma resection.

OBJECTIVE: Cardiac sarcoma represents a rare and aggressive form of cancer with a paucity of data to produce outcome-driven evidence-based guidelines. Current surgical management consists of resection with postoperative therapy (chemotherapy, radiation, or both) offered on a selective, individualized basis. This study was designed to determine whether postoperative therapy was associated with improved overall survival after resection. METHODS: The National Cancer Database was used to identify patients with cardiac sarcoma between 2004 and 2015. Patient characteristics were stratified by treatment (surgical, nonsurgical, and none), and treatment was analyzed by stage. Overall survival, assessed with Kaplan-Meier methodology, was compared between patients who received postoperative therapy and those who did not following resection. Multivariable survival modeling using a Weibull model identified risk factors associated with survival while controlling for confounders. RESULTS: The study included 617 patients diagnosed with cardiac sarcoma. Only 24% (149/617) of patients were diagnosed with early-stage disease. Angiosarcoma represented 48% (298/617) of cases and was the most commonly identified histologic subtype. 60% (372/617) underwent surgical resection and 58% (216/372) of those patients were treated with postoperative therapy. Following surgery, median survival was more than doubled for patients treated with postoperative therapy (19 months vs 8 months, P = .026). However, 5-year overall survival was similar between the groups. Multivariable analysis confirmed an improvement in survival with postoperative therapy (hazard ratio, 0.68; 95% confidence interval, 0.51-0.91, P = .009). CONCLUSIONS: Postoperative therapy is associated with better median survival following resection of cardiac sarcoma. However, at 5 years, the difference in overall survival is not statistically significant.

Unicuspid Aortic Valve Repair Using Geometric Ring Annuloplasty.

BACKGROUND: Unicuspid aortic valves (Sievers type 2 bicuspid) are characterized by major fusion and clefting of the right-left coronary commissure, and minor fusion of the right-noncoronary commissure. Repair has been difficult because of two fusions, variable relative sinus sizes, and peripheral leaflet deficiencies or tears after balloon valvuloplasty. METHODS: Twenty unicuspid aortic valves patients underwent valve repair in nine institutions. Right-left major fusion and right-noncoronary minor fusion occurred in 17 of 20 (85%). Commissurotomy was performed on the minor fusion, and a bicuspid annuloplasty ring with circular base geometry and two 180-degree subcommissural posts was sutured beneath the annulus, equalizing the annular circumferences of the fused and nonfused cusps. The nonfused leaflet was plicated, and the cleft in the major fusion was closed linearly until leaflet effective heights and lengths became greater than 8 mm and equal, respectively. RESULTS: Average age (mean ± SD) was 22.3 ± 12.3 years (range, 13 to 58), 12 of 20 (60%) were symptomatic, 10 of 20 (50%) required aortic aneurysm resection. Pre-repair hemodynamic data included mean systolic valve gradient 25.8 ± 12.9 mm Hg, aortic insufficiency grade 2.9 ± 1.2, and annular diameter 24.7 ± 3.3 mm. No mortality or major complications occurred. Post-repair annular (ring) size was 20.5 ± 1.3 mm, mean gradient fell to 16.2 ± 5.9 mm Hg, and aortic insufficiency grade decreased to 0.1 ± 0.3 (P < .001). At an average follow-up of 11 months (range, 1 to 22), all 20 patients were asymptomatic and had returned to full activity. CONCLUSIONS: Aortic ring annuloplasty reduced annular diameter effectively, recruiting more leaflet to midline coaptation. Minor fusion commissurotomy and annular remodeling to 180-degree commissures converted UAV repair to a simple and reproducible procedure.

Longitudinal Outcomes After Surgical Repair of Postinfarction Ventricular Septal Defect in the Medicare Population.

BACKGROUND: Patients undergoing post infarction ventricular septal defect repair are at high risk for early morbidity and mortality, but little is known about subsequent clinical events. This study uses short-term clinical data from The Society of Thoracic Surgeons National Database linked with Medicare data to examine longer term outcomes in these patients. METHODS: This was a retrospective review of The Society of Thoracic Surgeons National Database to link with Medicare data all adults (≥65 years) who underwent ventricular septal defect repair after a myocardial infarction between 2008 and 2012. The primary outcome was 1-year mortality. Risk factors for 1-year survival were modeled using a multivariable Cox regression. RESULTS: Five hundred thirty-seven patients were identified using The Society of Thoracic Surgeons database and Medicare linkage. Median age was 74 years, and 277 patients (52%) were men. One hundred ninety-two patients (36%) were supported preoperatively with an intraaortic balloon pump. Surgical status was emergent or salvage in 138 (26%), and 158 patients (29%) died within 30 days and 207 (39%) within 1 year. Among patients who survived to hospital discharge, 44% were discharged to a facility and 172 (32%) experienced at least 1 all-cause readmission within 1 year. Unadjusted 1-year mortality rates were 13% for elective patients and 69% for emergency status (P < .01). On multivariable analysis emergency/salvage status, older age, and concomitant coronary artery bypass grafting were independently associated with worse 1-year survival. CONCLUSIONS: These data suggest the greatest mortality risk in this patient population occurs in the first 30 days. Emergency or salvage status strongly predicts 1-year mortality. Optimizing physiologic derangements before operative repair may be considered when possible in this subgroup of patients.

Variation in Platelet Transfusion Practices in Cardiac Surgery.

OBJECTIVE: Although the morbidity associated with red blood cell transfusion in cardiac surgery has been well described, the impacts of platelet transfusion are less clearly understood. Given the conflicting results of prior studies, we sought to investigate the impact of platelet transfusion on outcomes after cardiac surgery across institutions in Maryland. METHODS: Using a multiinstitutional statewide database created by the Maryland Cardiac Surgery Quality Initiative, we retrospectively analyzed data from 10,478 patients undergoing isolated coronary artery bypass across 10 centers. Platelet transfusion practices were compared between institutions. Multivariate logistic regression model was used to analyze the association between platelet transfusion and 30-day mortality and postoperative complications. RESULTS: Rates of platelet transfusion varied between institutions from 4.4% to 24.7% ( P < 0.001), a difference that remained statistically significant in propensity score-matched cohorts. Among patients on preoperative antiplatelet therapy, transfusion rates varied from 8.5% to 46.4% ( P < 0.001). There was no statistically significant relationship between case volume and transfusion rates ( P = 0.815). In multivariate logistic regression, platelet transfusion was associated with increased risk of 30-day mortality (OR 2.43, P = 0.008), postoperative pneumonia (OR 2.21, P = 0.004), prolonged intubation (OR 2.05, P < 0.001), and readmission (OR 1.43, P = 0.039). CONCLUSIONS: Significant variation existed in platelet transfusion rates between institutions, even after controlling for various risk factors. This variation may be associated with increased mortality and length of stay. Further study is warranted to better understand risks associated with platelet transfusion. Standardizing practice may help reduce risk and conserve resources.

Comparing Frailty Markers in Predicting Poor Outcomes after Transcatheter Aortic Valve Replacement.

INTRODUCTION: Frailty is an important component of risk prognostication in transcatheter aortic valve replacement (TAVR). Objective markers of frailty, including sarcopenia, the modified Frailty Index (mFI), and albumin levels, have emerged, but little is known how such markers compare to each other in predicting outcomes after TAVR. We sought to define and compare these markers in predicting long-term outcomes after TAVR. METHODS: Patients who underwent TAVR at our institution from 2011 to 2016 were included. Indexed cross-sectional areas of the lumbosacral muscles on preoperative computed tomography scans were used to assess sarcopenia. Optimal cutoffs for sarcopenia were defined using a statistically validated method. mFI was calculated using an 11-point scale of clinical characteristics. The primary outcome was 2-year all-cause mortality. Adjusted survival analysis was used to analyze outcomes. RESULTS: A total of 381 patients were included in this study. Sarcopenia of the psoas muscles was associated with an increased risk of mortality on univariate (HR: 2.3, P = 0.01) and multivariate (HR: 2.5, P = 0.01) analysis. Sarcopenia of the paravertebral muscles was associated with increased risk of mortality only on univariate analysis (HR: 2.1, P = 0.03). Increased preoperative albumin levels were associated with decreased risk of mortality on univariate (HR: 0.3, P < 0.01) and multivariate analysis (HR: 0.3, P < 0.01). The (mFI) was not associated with mortality on univariate or multivariate analysis. DISCUSSION: Novel cutoffs for sarcopenia of the psoas muscles were determined and associated with decreased survival after TAVR. Sarcopenia and albumin levels may be better tools for risk prediction than mFI in TAVR.

Off-pump coronary artery bypass in octogenarians: results of a statewide, matched comparison.

OBJECTIVES: Off-pump coronary artery bypass grafting (OPCAB) may have advantages in the elderly. Although proven safe, it remains unclear whether OPCAB provides a short-term survival benefit in octogenarians. We sought to compare outcomes using propensity matching between OPCAB and conventional surgery in a statewide database. METHODS: We identified all octogenarians (≥ 80 years) who underwent isolated coronary artery bypass grafting (CAB) at 10 different centers in the state of Maryland from July 2011 to June 2016. We separated patients into two groups: OPCAB and on-pump coronary artery bypass (ONCAB). Patients were assigned propensity scores with a semi-parsimonious logistic regression model and matched 1:1 by the nearest-neighbor principle. A revascularization ratio was determined between the number of distal grafts sewn and number of diseased coronaries (≥ 50% stenosis). RESULTS: In total, 926 octogenarians underwent isolated CAB (8.2% of all CAB): 798 (86%) had ONCAB and 128 (14%) had OPCAB. Propensity matching yielded 128 well-matched pairs. Operative mortality was similar between groups (OPCAB 5.5% vs ONCAB 3.1%, p = 0.364). Rates of complications were similar between groups. OPCAB patients had a lower revascularization ratio (0.92 vs 1.15, p < 0.001), but more frequent use of left internal mammary artery (97 vs 89%, p = 0.017), and decreased intraoperative transfusion rates (33 vs 63%, p < 0.001). CONCLUSIONS: In comparing outcomes among octogenarians across the state of Maryland, OPCAB and ONCAB had similar mortality and morbidity. However, OPCAB was associated with a lower revascularization ratio. Thus, our results demonstrate no short-term survival benefit of OPCAB over ONCAB in octogenarians.

Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement.

OBJECTIVES: To assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR. BACKGROUND: The impact of CKD on mid-term outcomes of patients undergoing TAVR versus SAVR is unclear. METHODS: Patients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all-cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis. RESULTS: Moderate/severe CKD was present in 62.7% and 60.7% of high-risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high-risk patients with moderate/severe CKD, TAVR provided a lower 3-year MACRE rate compared with SAVR: 42.1% vs. 51.0, P = .04. Of 3,733 extreme- and high-risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3-year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P = .001]. CONCLUSIONS: TAVR results in lower 3-year MACRE versus SAVR in high-risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid-term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate-severe CKD would help elucidate the best treatment for these complex patients. TRIAL REGISTRATION: CoreValve US Pivotal Trial: NCT01240902. CoreValve Continued Access Study: NCT01531374.

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Bilateral Internal Mammary Artery Use in Diabetic Patients: Friend or Foe?

BACKGROUND: Bilateral internal mammary artery (BIMA) grafting in diabetic patients undergoing coronary artery bypass grafting remains controversial. Our study compared morbidity and mortality between (1) diabetic and nondiabetic BIMA patients and (2) diabetic BIMA versus diabetic patients who underwent left internal mammary artery (LIMA) grafting only. METHODS: Patients who underwent isolated coronary artery bypass grafting from July 2011 to June 2016 at any of the 10 Maryland Cardiac Surgery Quality Initiative centers were propensity scored across 16 variables. Diabetic BIMA patients were matched 1:1 by nearest neighbor matching to nondiabetic BIMA patients and were separately matched 1:1 to diabetic LIMA patients. We calculated observed-to-expected (O/E) ratios for composite morbidity/mortality, operative mortality, unplanned reoperation, stroke, renal failure, prolonged ventilation, and deep sternal wound infection and compared ratios among matched populations. RESULTS: During the study period, 812 coronary artery bypass grafting patients received BIMA grafts, including 302 patients (37%) with diabetes. We matched 259 diabetic and nondiabetic BIMA patients. O/E ratios were higher in matched diabetic (versus nondiabetic) BIMA patients when comparing composite morbidity/mortality, reoperation, stroke, renal failure, and prolonged ventilation (all O/E ratios >1.0); however, the O/E ratio for operative mortality was higher in nondiabetic BIMA patients. We additionally matched 292 diabetic BIMA to diabetic LIMA patients. Diabetic BIMA patients had a higher O/E ratio for composite morbidity/mortality, operative mortality, stroke, renal failure, and prolonged ventilation. CONCLUSIONS: In this statewide analysis, diabetic patients who received BIMA grafts (compared with diabetic patients with LIMA grafts or nondiabetic patients with BIMA grafts) had higher O/E ratios for composite morbidity/mortality as a result of higher O/E ratios for major complications.

Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement.

BACKGROUND: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients. METHODS: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed. RESULTS: At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10). CONCLUSIONS: Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli.

Less Is More: Results of a Statewide Analysis of the Impact of Blood Transfusion on Coronary Artery Bypass Grafting Outcomes.

BACKGROUND: Debate persists over the association between blood transfusions, especially those considered discretionary, and outcomes after cardiac operations. Using data from the Maryland Cardiac Surgery Quality Initiative, we sought to determine whether outcomes differed among coronary artery bypass grafting (CABG) patients receiving 1 U of red blood cells (RBCs) vs none. METHODS: We used a statewide database to review patients who underwent isolated CABG from July 1, 2011, to June 30, 2016, across 10 Maryland cardiac surgery centers. We included patients who received 1 U or fewer of RBCs from the time of the operation through discharge. Propensity scoring, using 20 variables to control for treatment effect, was performed among patients who did and did not receive a transfusion. These two groups were matched 1:1 to assess for differences in our primary outcomes: operative death, prolonged postoperative length of stay (>14 days), and a composite postoperative respiratory complication of pneumonia or reintubation, or both. RESULTS: Of 10,877 patients who underwent CABG, 6,124 (56%) received no RBCs (group 1) during their operative hospitalization, and 981 (9.0%) received 1 U of RBCs (group 2), including 345 of 981 patients (35%) who received a transfusion intraoperatively. Propensity score matching generated 937 well-matched pairs. Compared with group 2, propensity-matched analysis revealed significantly greater 30-day survival in group 1 (99% vs 98%, p = 0.02) and reduced incidence of prolonged length of stay (3.7% vs 4.0%, p < 0.01). CONCLUSIONS: Our collaborative statewide analysis demonstrated that even 1 unit of blood was associated with significantly worse survival and longer length of stay after CABG. Multiinstitutional quality initiatives may seek to address discretionary transfusions and possess the potential to improve patient outcomes.

A Comprehensive Risk Score to Predict Prolonged Hospital Length of Stay After Heart Transplantation.

BACKGROUND: Prolonged hospital length of stay (PLOS) after heart transplantation increases cost and morbidity. To better inform care, we developed a risk score to identify patients at risk for PLOS after heart transplantation. METHODS: We queried the United Network for Organ Sharing Scientific Registry of Transplant Recipients database for adult patients who underwent isolated heart transplantation from 2003 to 2012. The population was randomly divided into a derivation cohort (80%) and a validation cohort (20%). The outcome of interest was PLOS, defined as a posttransplant hospital length of stay of more than 30 days. Associated univariables (p < 0.20) in the derivation cohort were included in a multivariable model, and a risk index was derived from the adjusted odds ratios of significant covariates. RESULTS: During the study period, 16,723 patients underwent heart transplantation with an average PLOS of 19 ± 21 days, and 2,020 orthotopic heart transplant recipients (12%) had PLOS. Baseline characteristics were similar between the derivation and validation cohorts. Twenty-four recipient and nine donor variables, cold ischemic time, and center volume were tested as univariables. Seventeen covariates significantly affected PLOS and comprised the prolonged hospitalization after heart transplant risk score, which was stratified into three risk groups. The risk model was subsequently validated, and predicted rates of PLOS correlated well with observed rates (R = 0.79). Rates of PLOS in the validation cohort were 8.3%, 11%, and 22% for low, moderate, and high risk groups, respectively. CONCLUSIONS: The risk of PLOS after heart transplantation can be determined at the time of transplant. The prolonged hospitalization after heart transplant score may lead to individualized postoperative management strategies to reduce duration of hospitalization for patients at high risk.

Subclavian/Axillary Access for Self-Expanding Transcatheter Aortic Valve Replacement Renders Equivalent Outcomes as Transfemoral.

BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed. RESULTS: Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. CONCLUSIONS: Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.

Complications After Self-expanding Transcatheter or Surgical Aortic Valve Replacement.

Procedural complications following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high-risk SAVR patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve. The rates of major procedural and vascular complications occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for TAVR vs SAVR patients. All-cause mortality, stroke, myocardial infarction, and major infection were similar in both periods post procedure. Within 0-3 days, the major vascular complication rate was significantly higher with TAVR (P = 0.003). Life-threatening or disabling bleeding (P < 0.001), encephalopathy (P = 0.02), atrial fibrillation (P < 0.001), and acute kidney injury (P < 0.001) were significantly higher with SAVR. Non-iliofemoral TAVR approaches had a higher incidence of major or life-threatening or disabling bleeding at 0-3days (P < 0.05). Procedural complications unique to TAVR included coronary occlusion 0.5% (2) and TAVR pop outs 2.8% (11) with no valve embolizations. Pop outs were similar between iliofemoral 2.8% (9/324) and non-iliofemoral approaches 3.0% (2/66). Procedural complications unique to SAVR included aortic dissection 0.8% (3/357) and injury to other heart structures 2.0% (7/357). The procedural complication profiles of TAVR and SAVR are unique. Intraoperative deaths were seen in TAVR only. Mortality at 3 and 30 days was similar. The higher incidence of some complications likely reflects the greater invasiveness of SAVR in this aged high-risk population.

Differential Impact of Serial Measurement of Nonplatelet Thromboxane Generation on Long-Term Outcome After Cardiac Surgery.

BACKGROUND: Systemic thromboxane generation, not suppressible by standard aspirin therapy and likely arising from nonplatelet sources, increases the risk of atherothrombosis and death in patients with cardiovascular disease. In the RIGOR (Reduction in Graft Occlusion Rates) study, greater nonplatelet thromboxane generation occurred early compared with late after coronary artery bypass graft surgery, although only the latter correlated with graft failure. We hypothesize that a similar differential association exists between nonplatelet thromboxane generation and long-term clinical outcome. METHODS AND RESULTS: Five-year outcome data were analyzed for 290 RIGOR subjects taking aspirin with suppressed platelet thromboxane generation. Multivariable modeling was performed to define the relative predictive value of the urine thromboxane metabolite, 11-dehydrothromboxane B2 (11-dhTXB2), measured 3 days versus 6 months after surgery on the composite end point of death, myocardial infarction, revascularization or stroke, and death alone. 11-dhTXB2 measured 3 days after surgery did not independently predict outcome, whereas 11-dhTXB2 >450 pg/mg creatinine measured 6 months after surgery predicted the composite end point (adjusted hazard ratio, 1.79; P=0.02) and death (adjusted hazard ratio, 2.90; P=0.01) at 5 years compared with lower values. Additional modeling revealed 11-dhTXB2 measured early after surgery associated with several markers of inflammation, in contrast to 11-dhTXB2 measured 6 months later, which highly associated with oxidative stress. CONCLUSIONS: Long-term nonplatelet thromboxane generation after coronary artery bypass graft surgery is a novel risk factor for 5-year adverse outcome, including death. In contrast, nonplatelet thromboxane generation in the early postoperative period appears to be driven predominantly by inflammation and did not independently predict long-term clinical outcome.

Long-term follow-up of continuous flow left ventricular assist devices: complications and predisposing risk factors.

PURPOSE: To assess LVAD complications and their overall effect on mortality and determine factors associated with development of early and long-term complications. METHODS: A retrospective cohort study of patients who underwent continuous flow LVAD placement between January 1, 2000 and November 30, 2013 was performed. The incidence of complications (sepsis or bacteremia, driveline infections, gastrointestinal bleeding, pump thrombosis, cerebrovascular accidents and anemia requiring transfusion) was collected and logistic regression and Cox proportional hazards analyses were performed. RESULTS: 108 patients met our inclusion criteria. Median length of follow-up was 2.2 years. In univariable logistic regression analysis, higher blood urea nitrogen (BUN), creatinine clearance <60, no prior inotrope use, higher INTERMACS class and lower platelet count were associated with early complications. On multivariable analysis, factors associated with early complications included higher BUN (odds ratio (OR) 1.03, 95% confidence interval (CI) 1.001-1.06 per mg/dL BUN), no prior inotrope use (OR 4.92, 95% CI 1.64- 14.7) and lower platelet count (OR 4.29, 95% CI 1.45-12.7 <200 10(3) cu mm); 24% of patients developed early complications and 18.5% developed an early and late complication. Early complications were significantly associated with death (p = 0.017). The presence of 2 or more complications was associated with a 2.7-fold increase in the odds of death (p = 0.016) and odds of death increased by 20% with each subsequent complication (p = 0.004). CONCLUSIONS: LVADs are associated with significant long-term complications including stroke and sepsis and minimizing time on LVADs may decrease the risk of complications and subsequent morbidity and mortality.