Management of Postprocedural Conduction Disturbances Using a Prespecified Algorithm in the Optimize PRO Study.

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO+ valves. Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB). Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death. Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge.

Prevalence of Neurovascular Microemboli After Transcatheter Aortic Valve Replacement.

Background: Neurolotic sequelae after transcatheter aortic valve replacement (TAVR) can cause significant morbidity and mortality. Transcranial Doppler (TCD) imaging can show real-time high intensity transient signals (HITS), which reflect active microembolization. Although it is well known that intraprocedural microembolism occurs, it is not known if this embolic phenomenon continues in the postprocedural period. We investigated whether microemboli occur post-TAVR and whether we could determine any clinical, procedural, or echocardiographic predictors. Methods: We evaluated HITS in 51 consecutive patients undergoing unprotected TAVR with low-, intermediate-, or high-risk Society of Thoracic Surgeons score. Patients were excluded if they did not have temporal windows for insonation of the middle cerebral artery or if they were not willing to participate. Primary outcomes of HITS 24 hours post-TAVR were observed using a Philips iU22 TCD. TCD was performed at 3 time points (pre-, peri-, and post-TAVR) for each patient, before, during, and 24 hours postprocedure. Results: While no HITS were detected in any of the patients preoperatively, all patients had HITS during the procedure. Interestingly, 56.8% had HITS 24 hours post-TAVR. One patient with HITS post-TAVR had a stroke 48 hours after TAVR. Conclusion: We observed a high prevalence of microemboli 24 hours post-TAVR. None of the predictors for intraprocedural microembolism seemed to play an important role for post-TAVR microemboli.

Temporal trends in outcomes following inpatient transcatheter aortic valve replacement.

INTRODUCTION: Despite the growing adoption of transcatheter aortic valve replacement (TAVR), there remains a lack of clinical data evaluating procedural safety and discharge practices. AIMS: This study aims to investigate if there have been improvements in postoperative clinical outcomes following TAVR. METHODS: In this large-scale, retrospective cohort study, patients who underwent TAVR as an inpatient were identified from 2016 to 2020 using the National Readmissions Database. The primary outcome was temporal trends in the rates of discharge to home. Secondary endpoints assessed annual discharge survival rates, 30-day readmissions, length of stay, and periprocedural cardiac arrest rates. RESULTS: Over the 5-year study period, a total of 31,621 inpatient TAVR procedures were identified. Of these, 79.2 % of patients were successfully discharged home with home disposition increasing year-over-year from 74.5 % in 2016 to 85.9 % in 2020 (Odds ratio: 2.01; 95 % CI 1.62-2.48, p < 0.001). The mean annual discharge survival rate was 97.7 % which did not change significantly over the 5-year study period (p = 0.551). From 2016 to 2020, 30-day readmissions decreased from 14.0 % to 10.3 %, respectively (p = 0.028). Perioperative cardiac arrest occurred in 1.8 % (n = 579) of cases with rates remaining unchanged during the study (p = 0.674). CONCLUSION: Most TAVR patients are successfully discharged alive and home, with decreasing 30-day readmissions observed over recent years. This data suggests potential improvements in preoperative planning, procedural safety, and postoperative care. Despite perioperative cardiac arrest being associated with high mortality, it remains a relatively rare complication of TAVR.

Impact of left ventricular ejection fraction and aortic valve gradient on mortality following transcatheter aortic valve intervention.

BACKGROUND: Data regarding the impact of reduced left ventricular ejection fraction (LVEF) and/or reduced mean aortic valve gradient (AVG) on outcomes following transcatheter aortic valve intervention (TAVI) have been conflicting. We sought to assess the relationship between LVEF, AVG, and 1-year mortality in patients undergoing TAVI. METHODS: We prospectively evaluated 298 consecutive adults undergoing TAVI from 2015 to 2018 at an academic tertiary medical center. Patients were categorized according to LVEF and mean AVG. The primary outcome of interest was all-cause mortality at 1 year. RESULTS: Of 298 adults undergoing TAVI, 66 (22.1%) had baseline LVEF ≤45% while 232 (77.9%) had baseline LVEF >45%; 173 (58.1%) had baseline AVG < 40mmHg while 125 (41.9%) had baseline AVG ≥ 40mmHg. Rates of 1-year all-cause mortality were significantly higher in patients with LVEF ≤45% (28.8% vs 12.1%, p = 0.001) and those with AVG < 40mmHg (19.7% vs 10.4%, p = 0.031) compared to those with LVEF >45% and AVG ≥ 40mmHg respectively. In multivariable analysis, higher AVG (per mmHg) (OR 0.97, 95% CI 0.94-0.99, p = 0.026) was noted to be independently associated with lower rates of 1-year mortality, while LVEF was not (OR 0.98, 95% CI 0.96-1.01). CONCLUSIONS: In this prospective, contemporary registry of adults undergoing TAVI, while 1-year unadjusted mortality rates are significantly higher in patients with reduced LVEF and reduced AVG, risk-adjusted mortality at 1 year is only higher in those with reduced AVG - not in those with reduced LVEF.

Diagnosis related group and outcomes following transcatheter aortic valve implantation.

BACKGROUND: The association between Medicare Severity-Diagnosis Related Group (DRG) and early and intermediate-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) has not been well studied. We aimed to assess the relationship between DRG and 30-day and 1-year mortality in patients undergoing TAVI. METHODS: The study population included 289 patients with severe symptomatic AS who underwent TAVI from December 2015 to June 2018 at an academic tertiary care medical center. Patients were categorized as DRG 266 or DRG 267, specifying TAVI with or without major complication or comorbidities respectively. RESULTS: Of the 289 patients, 182 patients (63.0%) were classified under DRG 267 and 107 patients (37.0%) under DRG 266. The DRG 266 group had longer hospital lengths of stay and higher rates of discharge to a skilled nursing facility. While rates of in-hospital and 30-day mortality were similar in both DRG groups, the DRG 266 group had higher 1-year all-cause mortality (26.2% vs 8.8%, P less than .001). In multivariable analysis, serum creatinine (OR 1.42, 95%CI 1.05-1.93) was the only independent predictor of 1-year mortality in the DRG 266 group while atrial fibrillation (OR 3.04, 95%CI 1.03-8.92) was the only independent predictor of mortality in the DRG 267 group. CONCLUSIONS: In this prospective registry of patients undergoing TAVI, while rates of in-hospital and 30-day mortality were similar in both DRG 266 and 267 groups, the DRG 266 group had higher 1-year all-cause mortality. Distinct predictors of mortality in each DRG group exist.

Predictors of 1-Year Mortality in Men Versus Women Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Although gender-related disparities in intermediate-term outcomes have been reported after transcatheter aortic valve implantation (TAVI), disparate predictors of mortality in men and women who underwent TAVI have not been well studied. This prospective institutional registry study included 297 consecutive patients (153 men, 144 women) who underwent transfemoral TAVI from December 2015 to June 2018 at an academic tertiary medical center. Baseline and clinical characteristics, procedural data, and clinical outcomes at 1 year were recorded. Mortality rates at 1 year were 11.1% and 20.3% in women and men, respectively (p = 0.033). Risk-adjusted mortality was significantly higher in men who underwent TAVI than in women (odds ratio [OR] 2.45, 95% confidence interval [CI] 1.24 to 4.87, p = 0.010). Gender-specific risk-adjusted predictors of 1-year mortality post-TAVI included the presence of atrial fibrillation (OR 4.20, 95% CI 1.31 to 13.46, p = 0.016) and peripheral artery disease (OR 4.64, 95% CI 1.04 to 20.71, p = 0.044) in women and presence of chronic obstructive pulmonary disease (OR 3.14, 95% CI 1.13 to 8.72, p = 0.029), higher serum creatinine (OR 1.57, 95% CI 1.15 to 2.15, p = 0.004), and lower body mass index (OR 0.88, 95% CI 0.80 to 0.97, p = 0.008) in men. In this prospective institutional registry of adults who underwent TAVI, risk-adjusted 1-year mortality is significantly lower in women, and disparate predictors of risk-adjusted 1-year mortality exist in men and women.

Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX System for Patients Presenting With Acute Coronary Syndrome.

Patient undergoing PCI can have distal embolization and microvascular obstruction despite normalization of epicardial blood flow. Aspiration thrombectomy has been studied previously to reduce infarct size, but prior methods of aspiration thrombectomy were associated with increased risk of stroke and is currently recommended as a bailout strategy. Penumbra CAT RX has been recently approved for aspiration thrombectomy, we evaluated the catheter's use in an academic cardiac catheterization lab. Patients undergoing cardiac catherization at an academic medical center who had deployment of the Penumbra CAT RX from 2017 through 2020 were included in the case series. TIMI flow pre and post procedure were determined by individual operator. Endpoints included 30-day cardiovascular death and post-procedural stroke. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. TIMI 3 flow was achieved in 88% of cases. There were no cases of 30-day cardiovascular death or post procedural stroke. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization laboratories with use in select cases. The Penumbra CAT RX appears to be safe and highly effective at thrombus removal in the acute setting without increased stroke risk as seen with manual aspiration thrombectomy.

A Stepwise Approach Utilizing a Double-Helix Wire Technique, Snare Capture and a Switch From a Transfemoral to Transradial Approach to Remove an Entrapped Balloon.

During an attempted PCI utilizing a femoral approach, a balloon became entrapped in the Left Circumflex Artery. Initial retrieval efforts including pulling the balloon and inflating a second balloon over the entrapment failed, the balloon fractured, and the distal end of the balloon apparatus migrated out of the guide catheter. We utilized a stepwise approach with a double helix wiring technique, snares and a change from a transfemoral to transradial approach to successfully retrieve the foreign bodies. This case highlights the importance of utilizing multiple techniques in series and understanding anatomical influences on equipment retrieval when single techniques and approaches fail.

Early Experience with the HeartMate Percutaneous Heart Pump from the SHIELD II Trial.

The HeartMate Percutaneous Heart Pump (PHP) is a novel circulatory support catheter delivering a self-expanding 24 French impeller across the aortic valve. The SHIELD II trial compares outcomes among heart failure patients undergoing high-risk percutaneous coronary intervention (HR-PCI) with the PHP versus Impella systems. The trial was halted in 2017 due to device malfunctions. We aimed to describe procedural, hemodynamic, and clinical outcomes among HR-PCI patients treated with PHP as part of the SHIELD II trial roll-in phase. Procedural, hemodynamic, and 90 day outcomes were assessed among patients undergoing HR-PCI with a left ventricular ejection fraction ≤35% and last patent coronary conduit, unprotected left main disease, or significant three vessel disease. The primary endpoint was the 90 day composite of cardiovascular death, myocardial infarction, stroke, repeat revascularization, major bleeding, new/worsening aortic regurgitation, and severe hypotension. Among 75 roll-in phase patients, PHP support duration was 101 ± 53 minutes with 2.5 ± 1.4 coronary lesions treated per patient. Compared with predevice values, the PHP system increased cardiac power and mean arterial pressure. Maximum recorded device flows were 0.4-6.2 L/minute with 26% (n = 19/73) and 9.6% (n = 7/73) of patients achieving peak flows above 3.5 or 5.0 L/minute, respectively. Five PHP device malfunction events (6.7%) were observed. At 90 days, the composite endpoint occurred in 24.3% (18/74) of patients. Early PHP experience demonstrated successful device performance in the majority of enrolled patients; however, unexpected malfunctions led to device revision. Completion of the SHIELD II trial will be required to confirm the safety and efficacy of this iteration of the PHP system in HR-PCI.

Distressed Communities Index in Patients Undergoing Transcatheter Aortic Valve Implantation in an Affluent County in New York.

BACKGROUND: The clinical impact of the distressed communities index (DCI), a composite measure of economic well-being based on the U.S. zip code, is becoming increasingly recognized. Ranging from 0 (prosperous) to 100 (distressed), DCI's association with cardiovascular outcomes remains unknown. We aimed to study the association of the DCI with presentation and outcomes in adults with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve intervention (TAVR) in an affluent county in New York. METHODS: The study population included 286 patients with severe symptomatic AS or degeneration of a bioprosthetic valve who underwent TAVR with a newer generation transcatheter heart valve (THV) from December 2015 to June 2018 at an academic tertiary medical center. DCI for each patient was derived from their primary residence zip code. Patients were classified into DCI deciles and then categorized into 4 groups. The primary and secondary outcomes of interest were 30-day, 1-year, and 3-year mortality, respectively. RESULTS: Among 286 patients studied, 26%, 28%, 28%, and 18% were categorized into DCI groups 1-4, respectively (DCI <10: n = 73; DCI 10-20: n = 81; DCI 20-30: n = 80; DCI >30: n = 52). Patients in group 4 were younger with worse kidney function compared to patients in groups 1 and 2. They also had smaller aortic annuli and were more likely to receive a smaller THV. No significant difference in hospital length of stay or distribution of in-hospital, 30-day, 1-year, and 3-year mortality was demonstrated. CONCLUSIONS: While the DCI was associated with differences in the clinical and anatomic profile, it was not associated with differences in clinical outcomes in this prospective observational study of adults undergoing TAVR suggesting that access to care is the likely discriminator.

Balloon Aortic Valvuloplasty With Same-Setting Complex Percutaneous Coronary Intervention in the TAVR Era: A Case Series.

BACKGROUND: The use of balloon aortic valvuloplasty (BAV) prior to same-setting complex percutaneous coronary intervention (PCI) in patients with severe aortic stenosis (AS) and concomitant severe coronary artery disease (CAD) has not been well studied in the era of transcatheter aortic valve replacement (TAVR). METHODS: We reviewed 379 BAVs performed between January 2016 and April 2020 at an academic tertiary-care medical center. Overall, 327 BAVs were performed in the setting of TAVR. Of the remaining 52 BAVs, 20 were performed immediately prior to same-setting complex PCI. We examined the baseline and procedural data, and clinical outcomes of these cases. RESULTS: Mean patient age was 81 ± 9 years and 70% were men. Chronic kidney disease (40%), diabetes mellitus (35%), and atrial fibrillation (35%) were the most prevalent comorbidities. Rotational atherectomy was performed in 75% of cases and Impella device was utilized in 15%. PCI of distal left main coronary artery and proximal left anterior descending coronary artery was performed in 30% and 80% of cases, respectively. Mean contrast volume was 149 ± 61 mL, fluoroscopy time was 37 ± 20 minutes, total skin dose was 2821 ± 1931 mGy, and total area dose was 18651 ± 12090 µGy/m². Rate of in-hospital complications was low, with a 0% mortality and stroke rate. Eighty percent of patients were referred for TAVR; 70% went on to undergo successful TAVR and 10% deferred TAVR due to improvement in symptoms. CONCLUSIONS: BAV with same-setting complex PCI is safe and feasible in patients with severe AS and severe CAD awaiting TAVR.

Giant Cell, Giant Problems: A Case of Giant Cell Myocarditis Complicated by Cardiogenic Shock and Refractory Ventricular Tachycardia Managed With a Mechanical Circulatory Support Device.

This report reviews the management of a case of Giant Cell Myocarditis (GCM) that presented with cardiogenic shock. This case highlights the importance of a multi-disciplinary approach to the care of these patients including the use of a mechanical circulatory support (MCS) device.

TAVR in a 65-Year-Old Man With a Bicuspid Aortic Valve With Extremely Large Annulus and Severe Left Ventricular Dysfunction.

This case illustrates that transfemoral transcatheter aortic valve replacement is safe and feasible in patients with bicuspid aortic stenosis with extremely large annulus and concomitant severe left ventricular dysfunction.

Sex-Related Differences in Early- and Long-Term Mortality After Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

BACKGROUND: Observational data suggest that early- and long-term outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differ significantly between men and women, but have demonstrated conflicting results. This study sought to examine early- and long-term mortality with TAVR and SAVR in women versus men. METHODS: Electronic search was performed until February 2018 for studies reporting sex-specific mortality following TAVR or isolated SAVR. Data were pooled using random-effects models. Outcomes included rates of early mortality (in hospital or 30 days) and long term (1 year or longer). RESULTS: With 35 studies, a total of 80,928 patients were included in our systematic review and meta-analysis, including 40,861 men and 40,067 women. Pooled analyses suggested considerable sex-related differences in longterm mortality following TAVR and SAVR. Following SAVR, women had higher long-term mortality (odds ratio [OR], 1.35; 95% confidence interval [CI], 1.16-1.56; P<.001) and a trend toward higher early mortality (OR, 1.69; 95% CI, 0.97-2.97; P=.07) compared to men. Following TAVR, women had lower long-term mortality (OR, 0.78; 95% CI, 0.71-0.86; P<.001) and no difference in early mortality (OR, 1.09; 95% CI, 0.96-1.23; P=.17) compared to men. CONCLUSIONS: In this systematic review and meta-analysis, women had higher long-term mortality and a trend toward higher early mortality compared to men following SAVR. Following TAVR, women had lower long-term mortality and no difference in early mortality compared with men.

Impact of Severity of Chronic Kidney Disease on Management and Outcomes Following Transcatheter Aortic Valve Replacement With Newer-Generation Transcatheter Valves.

BACKGROUND: The association between chronic kidney disease (CKD) and outcomes following transcatheter aortic valve replacement (TAVR) in the setting of newer-generation transcatheter heart valves (THVs) is not well known. Accordingly, we sought to assess the impact of CKD severity on outcomes in adults undergoing TAVR with newer-generation THVs. METHODS: The study population included 298 consecutive patients who underwent TAVR with a newer-generation THV (Sapien 3 [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro [Medtronic]) from December 2015 to June 2018 at an academic tertiary medical center. Patients were classified into three groups: group I, defined as creatinine clearance (CrCl) ≥60 mL/ min (n = 133); group II, defined as CrCl ≥30 mL/min and <60 mL/min (n = 128); and group III, defined as CrCl <30 mL/min (n = 37). RESULTS: Median length of stay was longer in groups II and III (2.0 days in group I vs 3.0 days in group II vs 4.0 days in group III; P<.01). While rates of 30-day readmission were significantly higher in groups II and III compared with group I (14.5% in group I vs 26.6% in group II vs 37.1% in group III; P<.01), rates of in-hospital and 30-day mortality and disabling stroke were similar. In multivariable analysis, CKD was independently associated with higher 30-day readmission rates (group II: odds ratio, 2.10; 95% confidence interval 1.02-4.32; group III: odds ratio, 3.52; 95% confidence interval, 1.40-8.87; group I: referent). CONCLUSIONS: In this prospective study of adults undergoing TAVR with newer-generation THVs, moderate and severe CKD was associated with a nearly 2-fold and 3-fold higher risk of 30-day readmission, respectively.

Transcatheter Tricuspid Valve-in-Valve Replacement Via Right Internal Jugular Vein Access in a 39-Year-Old Woman.

Transcatheter tricuspid valve-in-valve replacement via right internal jugular is safe and feasible for failed bioprosthetic valve implantation. Challenging aspects include stiff wire advancement into the pulmonary artery for rail establishment and multiple push-pull manipulations for balloon and valve advancement.

Impact of Race and Ethnicity on the Clinical and Angiographic Characteristics, Social Determinants of Health, and 1-Year Outcomes After Everolimus-Eluting Coronary Stent Procedures in Women.

Background The impact of race/ethnicity on coronary stent outcomes in women is unknown. We compared baseline characteristics, social determinants of health, and 1-year outcomes in female African Americans (AA) and Hispanic/Latinas (HL) versus white women after coronary everolimus-eluting stent implantation in all-comer patients. Methods and Results We pooled 1863 women from the PLATINUM Diversity (n=1057 women) and PROMUS ELEMENT PLUS (n=806 women) postapproval studies, with some overlap in study sites. Social determinants of health data were only available for PLATINUM Diversity. The primary end point was 1-year major adverse cardiac events (death, myocardial infarction, or target vessel revascularization). Outcomes were risk adjusted using multivariate Cox regression. The study sample comprised 1417 white (76.1%, reference group), 296 AA (15.9%), and 107 HL (5.7%) women. AA were older, and both AA and HL had more diabetes mellitus and hypertension than white women. AA had larger reference vessel diameters but less lesion calcification, whereas HL had less lesion tortuosity but more calcification. Compared with white women, there was a trend toward higher unadjusted 1-year major adverse cardiac events in AA (12.0% versus 8.0%; P=0.06) but similar rates in HL (11.0% versus 8.0%; P=0.32), and after risk adjustment, there were no differences (AA women: hazard ratio, 1.47; 95% CI, 1.00-2.17; HL women: hazard ratio, 1.33; 95% CI, 0.71-2.44). AA had a 3-fold higher adjusted risk of 1-year myocardial infarction (hazard ratio, 3.45; 95% CI, 1.72-7.14; P=0.01) and increased risk of target vessel revascularization (hazard ratio, 1.82; 95% CI, 1.10-2.94; P=0.02). Independent predictors of major adverse cardiac events included renal disease, prior myocardial infarction, silent ischemia, history of stroke, and multivessel disease. Conclusions Race and ethnicity confer heterogeneity in women undergoing everolimus-eluting stent implantation. Despite more comorbidities and less favorable social determinants of health, AA and HL women have similar 1-year major adverse cardiac events to white women, although AA women seem to have a higher risk of 1-year myocardial infarction. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02240810.

Gender Disparities in Management and Outcomes Following Transcatheter Aortic Valve Implantation With Newer Generation Transcatheter Valves.

The impact of gender on management and early outcomes after transcatheter aortic valve implantation (TAVI) in the setting of newer generation transcatheter heart valves (THVs) is not well known. We evaluated gender-specific differences on clinical management and in-hospital outcomes in adults who underwent TAVI with newer generation THVs. The study population included 298 consecutive patients who underwent TAVI and received a newer generation THV (Sapien 3 [Edwards Lifesciences, Irvine, California] or Corevalve Evolut R or Evolut Pro [Medtronic, Minneapolis, Minnesota]) from December 2015 to June 2018 at an academic tertiary medical center. Of the 298 patients, 154 (52%) were men and 144 (48%) were women. Compared with men, women were older, had lower serum creatinine, higher left ventricular ejection fraction, and lower rates of multiple co-morbidities, including previous coronary artery bypass graft surgery, previous myocardial infarction, and atrial fibrillation. Women were noted to have smaller aortic annular area and perimeter and underwent implantation of smaller THVs than men. At the time of discharge, women were more frequently prescribed a P2Y12 inhibitor (primarily clopidogrel) and less frequently prescribed oral anticoagulation (namely warfarin). Hospital length of stay and in-hospital rates of mortality, disabling stroke, and pacemaker were similar in men and women. In conclusion, in this observational prospective study of adults who underwent TAVI with newer generation THVs, while gender-related disparities in clinical presentation and procedural management were observed, no significant difference in clinical outcomes were noted in men and women. Further studies examining gender-related differences in procedural and postprocedural care after TAVI in the contemporary era are warranted to better understand and optimize clinical outcomes in both men and women.

Bivalirudin versus heparin in patients undergoing percutaneous peripheral interventions: A systematic review and meta-analysis.

BACKGROUND: Bivalirudin may be an effective alternative anticoagulant to heparin for use in percutaneous peripheral interventions. We aimed to compare the safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing percutaneous peripheral intervention. METHODS: For this meta-analysis and systematic review, we conducted a search in PubMed, Medline, Embase, and Cochrane for all the clinical studies in which bivalirudin was compared to heparin as the procedural anticoagulant in percutaneous peripheral interventions. Outcomes studied included all-cause mortality, all-bleeding, major and minor bleeding, and access site complications. RESULTS: Eleven studies were included in the analysis, totaling 20,137 patients. There was a significant difference favoring bivalirudin over heparin for all-cause mortality (risk ratio 0.58, 95% CI 0.39-0.87), all-bleeding (risk ratio 0.62, 95% CI 0.50-0.78), major bleeding (risk ratio 0.61, 95% CI 0.39-0.96), minor bleeding (risk ratio 0.66, 95% CI 0.47-0.92), and access site complications (risk ratio 0.66, 95% CI 0.51-0.84). There was no significant difference in peri-procedural need for blood transfusions (risk ratio 0.79, 95% CI 0.57-1.08), myocardial infarction (risk ratio 0.87, 95% CI 0.59-1.28), stroke (risk ratio 0.77, 95% CI 0.59-1.01), intracranial bleeding (risk ratio 0.77, 95% CI 0.29-2.02), or amputations (OR 0.75, 95% CI 0.53-1.05). CONCLUSION: Our meta-analysis suggests that bivalirudin use for percutaneous peripheral interventions is associated with lower all-cause mortality, bleeding, and access site complications as compared to heparin. Further large randomized trials are needed to confirm the current results.

Contemporary Sex-Based Differences by Age in Presenting Characteristics, Use of an Early Invasive Strategy, and Inhospital Mortality in Patients With Non-ST-Segment-Elevation Myocardial Infarction in the United States.

BACKGROUND: Prior studies have reported higher inhospital mortality in women versus men with non-ST-segment-elevation myocardial infarction. Whether this is because of worse baseline risk profile compared with men or sex-based disparities in treatment is not completely understood. METHODS AND RESULTS: We queried the 2003 to 2014 National Inpatient Sample databases to identify all hospitalizations in patients aged ≥18 years with the principal diagnosis of non-ST-segment-elevation myocardial infarction. Complex samples multivariable logistic regression models were used to examine sex differences in use of an early invasive strategy and inhospital mortality. Of 4 765 739 patients with non-ST-segment-elevation myocardial infarction, 2 026 285 (42.5%) were women. Women were on average 6 years older than men and had a higher comorbidity burden. Women were less likely to be treated with an early invasive strategy (29.4% versus 39.2%; adjusted odds ratio, 0.92; 95% confidence interval, 0.91-0.94). Women had higher crude inhospital mortality than men (4.7% versus 3.9%; unadjusted odds ratio, 1.22; 95% confidence interval, 1.20-1.25). After adjustment for age (adjusted odds ratio, 0.96; 95% confidence interval, 0.94-0.98) and additionally for comorbidities, other demographics, and hospital characteristics, women had 10% lower odds of inhospital mortality (adjusted odds ratio, 0.90; 95% confidence interval, 0.89-0.92). Further adjustment for differences in the use of an early invasive strategy did not change the association between female sex and lower risk-adjusted inhospital mortality. CONCLUSIONS: Although women were less likely to be treated with an early invasive strategy compared with men, the lower use of an early invasive strategy was not responsible for the higher crude inhospital mortality in women, which could be entirely explained by older age and higher comorbidity burden.