Calculation of Mitral Valve Area by Continuity Equation Using Velocity-Time Integral From Mitral Valve Orifices After Mitral Clip.

BACKGROUND: This study investigates the hemodynamics of a dual-orifice mitral valve after mitral valve clip closure (MVCC) in patients with functional and nonfunctional mitral regurgitation (MR). If inflow velocity-time integral (VTi) of both orifices is equal, then the standard continuity equation can be applied to calculate the total mitral valve area (MVA). METHODS AND RESULTS: Adults undergoing MVCC placement were prospectively enrolled. With transesophageal echocardiography (TEE), the vena contracta (VC) of the medial and lateral mitral valve (MV) orifices were determined using color-flow Doppler and dual MV orifice areas were calculated. Valve orifices were classified as large vs small based on VC diameters. Continuous-wave Doppler measurements from both orifices were obtained. Forty-nine patients with severe MR (functional, n = 18) were enrolled. The VTi, mean gradient, peak gradient, and mean velocity of the larger vs smaller orifice were not significantly different, irrespective of MR etiology (P=nonsignificant). There was no difference in these parameters between large and small orifice regardless of MR mechanism (P=nonsignificant). There were no differences in the means of MVA as derived from either large or small VTi-derived and VC-derived areas (P=nonsignificant). CONCLUSIONS: Mitral valve inflow hemodynamics were the same regardless of the size differences between the large and small orifices. Therefore, total MVA can be calculated using the continuity equation in patients irrespective of MR mechanism. This allows for a derivation of total MVA at the time of MVCC placement to evaluate for mitral stenosis.

Impella support and acute kidney injury during high-risk percutaneous coronary intervention: The Global cVAD Renal Protection Study.

BACKGROUND: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). We sought to evaluate this finding by determining the occurrence of AKI during Impella-supported HR-PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline. METHODS AND RESULTS: In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR-PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR-PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella-supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella-supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m2 ) alone predicted AKI (adjusted odds ratio [AOR]: 4.915; 95% confidence intervals [CI]: 1.02-23.53, p = .046), and increasing contrast had insignificant effects on AKI during high-risk PCI (AOR: 1.15; 95% CI: 0.87-1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity. CONCLUSION: The incidence of AKI was lower during HR-PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR-PCI.

Comparison of Causes and Associated Costs of 30-Day Readmission of Transcatheter Implantation Versus Surgical Aortic Valve Replacement in the United States (A National Readmission Database Study).

Our current knowledge about comparative differences in 30-day readmissions and the impact of readmissions on overall costs after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is largely derived from clinical trials. The objectives of this study were to compare readmissions and costs for TAVI and SAVR in a nationally representative population-based sample. The Healthcare Cost and Utilization Project's National Readmission Database was used for the study. Hierarchical multivariable regression analyses were used to examine differences in the propensity score 1:1 matched cohort. The matched cohort included 4,682 patients who survived index procedures done from January through November 2013. Compared with SAVR, the rate of 30-day readmission was not significantly different for endovascular TAVI (16% vs 18%; p = 0.19); and was higher for the transapical TAVI (22% vs 17%; p <0.01) group. The 30-day cumulative costs were higher for the 2 endovascular TAVI ($51,025 vs $46,228; p = 0.03) and transapical TAVI ($59,575 vs $45,792; p <0.01). In multivariable analyses, the risk of 30-day readmission was similar for endovascular TAVI (odds ratio [OR] 0.93; 95% confidence interval [CI] 0.78 to 1.12) and was 27% higher for transapical TAVI (OR 1.27; 95% CI 1.02 to 1.57). Cumulative costs (index plus readmission costs) were 13% (ß 0.13; 95% CI 0.10 to 0.15) and 19% (ß 0.19; 95% CI 0.16 to 0.23) higher for the endovascular TAVI and transapical TAVI, respectively. In conclusion, the rate of readmissions was similar for endovascular TAVI and SAVR but the costs were 26% higher for TAVI than for SAVR.

Acute Heart Failure at the Time of Transcatheter Aortic Valve Replacement Does Not Increase Mortality.

OBJECTIVE: Patients presenting for transcatheter aortic valve replacement are often in acute on chronic heart failure, as indicated by elevated N-terminal pro-B-type natriuretic peptide. Many believe that elevated N-terminal pro-B-type natriuretic peptide is an indication to treat medically, reserving surgery until the patient is medically optimized. METHODS: A single-center transcatheter aortic valve replacement database was queried from December 2015 to November 2016 to identify patients undergoing transcatheter aortic valve replacement. Patients were divided into two cohorts based on preoperative N-terminal pro-B-type natriuretic peptide level. An analysis was then completed to assess outcomes such as length of intensive care unit stay, total length of stay, discharge to home, major complications, and mortality at 30 days. RESULTS: There were 142 patients (median age = 80 years, 44% female) with preoperative N-terminal pro-B-type natriuretic peptide data included (range = 106-73,500 pg/mL). The mean Society of Thoracic Surgeons predicative risk of mortality was 8%, and 46 patients (32%) had N-terminal pro-B-type natriuretic peptide of greater than 3000 pg/mL. N-terminal pro-B-type natriuretic peptide of greater than 3000 pg/mL was associated only with increased intensive care unit length of stay of greater than 24 hours (35% vs 9%, P = 0.0001). There was no statistical difference between cohorts with regard to total length of stay of greater than 3 days (24% vs 15%, P = 0.2), discharge to home (74% vs 83%, P = 0.3), major complication, or mortality at 30 days. CONCLUSIONS: Transcatheter aortic valve replacement is an appropriate and effective treatment for patients with aortic stenosis presenting with high N-terminal pro-B-type natriuretic peptide and acute on chronic heart failure.

Device Closure Versus Medical Therapy Alone for Patent Foramen Ovale in Patients With Cryptogenic Stroke: A Systematic Review and Meta-analysis.

Background: The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown. Purpose: To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke. Data Sources: PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings. Study Selection: Randomized trials enrolling adults with PFO and cryptogenic stroke that compared stroke outcomes (main outcome) and potential harms in those receiving transcatheter device closure versus medical therapy alone. Data Extraction: Two investigators independently extracted study data and rated risk of bias. Data Synthesis: Of 5 trials, 1 was excluded because it used a device that is no longer available due to high rates of complications and failure. Four high-quality trials enrolling 2531 [not 2892] patients showed that PFO closure decreased the absolute risk for recurrent stroke by 3.3% [not 3.2%] (risk difference [RD], −0.033 [95% CI, −0.062 to −0.004]) [not −0.032 (95% CI, −0.050 to −0.014)] compared with medical therapy. The treatment strategies did not differ in rates of transient ischemic attack or major bleeding. Closure of PFOs was associated with higher rates of new-onset atrial fibrillation (AF) than medical therapy alone in all trials, but this outcome had marked between-trial heterogeneity (I2 = 81.9%), and high event rates in some groups resulted in extreme values for CIs. Limitation: Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results. Conclusion: In patients with PFO and cryptogenic stroke, transcatheter device closure decreases risk for recurrent stroke compared with medical therapy alone. Because recurrent stroke rates are low even with medical therapy alone and PFO closure might affect AF risk, shared decision making is crucial for this treatment. Primary Funding Source: None.

Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database.

BACKGROUND: SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database. MATERIALS AND METHODS: The MAUDE database requires nationwide mandatory notification for adverse events on devices approved for clinical use. This database was searched for adverse events reported between 1 October 2015 and 25 December 2016, encountered after the placement of either BP-DES or DP-DES. Only those adverse events were included where the exposure period to the stents was comparable after the index procedure. Of all the adverse events reported, the event of interest was ST. RESULTS: A total of 951 adverse events were reported. ST occurred in 48/951 of all events, 31/309 and 17/642 when BP-DES or DP-DES were used, respectively (P=0.00001). Of the 31 ST events with BP-DES, 68% (21/31) occurred within less than or equal to 24 h of the index procedure and 52% (16/31) occurred within less than or equal to 2 h. CONCLUSION: Our results raise the possibility of an increased risk of ST, particularly early ST (within 24 h), with the recently approved BP-DES. However, because of the inherent limitations of reporting within the MAUDE database, these data merely highlight a potential need for additional surveillance and randomized trials to assess further the safety of the bioabsorbable platform.

Meta-analysis of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Left Main Coronary Artery Disease.

Despite the increase in use of percutaneous coronary intervention (PCI) in left main coronary disease, its efficacy compared with coronary artery bypass grafting (CABG) is unclear. We performed a meta-analysis of randomized controlled trials to assess the optimal revascularization strategy. Our search yielded 8 studies reporting relevant outcomes that were pooled using the inverse variance method, and the hazard ratio (HR) was calculated. The primary outcome was all-cause mortality, myocardial infarction (MI), or stroke (major adverse cardiac events [MACE]), and the secondary outcome was death/MI/stroke/repeat revascularization (expanded MACE). Differences in outcomes classified by follow-up duration (early: 0 to 1 year; late: 3 to 5 years) or anatomical complexity of coronary artery disease (SYNTAX score) were investigated. Our results suggest no difference in either early or late MACE (early: HR 0.81; 95% confidence interval [CI] 0.63 to 1.05; late: HR 1.12; 95% CI 0.80 to 1.56) or expanded MACE (early: HR 1.03; 95% CI 0.69 to 1.52; late: HR 1.16; 95% CI 0.95 to 1.43) between the 2 groups. There was an increased risk of expanded MACE with a high SYNTAX score for PCI (HR 1.47; 95% CI 1.13 to 1.92) at late follow-up. There were comparable rates of all-cause mortality and nonprocedural MI between the 2 groups with increased rates of repeat revascularization with PCI throughout the follow-up and higher rates of stroke with coronary artery bypass grafting early in the follow-up period. In conclusion, our analysis suggests that CABG may be preferable in patients with left main disease and high SYNTAX scores, assuming they are at low surgical risk, and PCI may be an acceptable alternative in patients with low-intermediate SYNTAX scores.

ST-Elevation Myocardial Infarction after Penetrating Thoracic Trauma.

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) may complicate penetrating thoracic trauma. CASE REPORT: This report describes a 42-year-old man who sustained a self-inflicted gunshot wound to the left chest. Electrocardiogram showed ST elevation in the inferior leads. Emergent catheterization was not recommended and conservative management was initiated. Cardiac catheterization 4 days later showed no perturbation of the coronary arteries, neither atherosclerotic nor traumatic. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: This case is unusual because it demonstrates a STEMI with no detectable plaque rupture or gunshot pellets on coronary catheterization. The decision to aggressively manage these patients with early coronary angiography depends on the hemodynamic status of the patient, their cardiac risk factors, and their ability to tolerate ischemic insult. In asymptomatic hemodynamically stable patients, conservative medical management should be considered. Myocardial infarction is a complication after penetrating thoracic trauma and should be considered in initial evaluation.

Hemodynamic Support With a Microaxial Percutaneous Left Ventricular Assist Device (Impella) Protects Against Acute Kidney Injury in Patients Undergoing High-Risk Percutaneous Coronary Intervention.

RATIONALE: Acute kidney injury (AKI) is common during high-risk percutaneous coronary intervention (PCI), particularly in those with severely reduced left ventricular ejection fraction. The impact of partial hemodynamic support with a microaxial percutaneous left ventricular assist device (pLVAD) on renal function after high-risk PCI remains unknown. OBJECTIVE: We tested the hypothesis that partial hemodynamic support with the Impella 2.5 microaxial pLVAD during high-risk PCI protected against AKI. METHODS AND RESULTS: In this retrospective, single-center study, we analyzed data from 230 patients (115 consecutive pLVAD-supported and 115 unsupported matched-controls) undergoing high-risk PCI with ejection fraction ≤35%. The primary outcome was incidence of in-hospital AKI according to AKI network criteria. Logistic regression analysis determined the predictors of AKI. Overall, 5.2% (6) of pLVAD-supported patients versus 27.8% (32) of unsupported control patients developed AKI (P<0.001). Similarly, 0.9% (1) versus 6.1% (7) required postprocedural hemodialysis (P<0.05). Microaxial pLVAD support during high-risk PCI was independently associated with a significant reduction in AKI (adjusted odds ratio, 0.13; 95% confidence intervals, 0.09-0.31; P<0.001). Despite preexisting CKD or a lower ejection fraction, pLVAD support protection against AKI persisted (adjusted odds ratio, 0.63; 95% confidence intervals, 0.25-0.83; P=0.04 and adjusted odds ratio, 0.16; 95% confidence intervals, 0.12-0.28; P<0.001, respectively). CONCLUSIONS: Impella 2.5 (pLVAD) support protected against AKI during high-risk PCI. This renal protective effect persisted despite the presence of underlying CKD and decreasing ejection fraction.

Pulmonary Hypertension and Atrial Septal Defect: Management Dilemma.

The decision making in patients with an atrial septal defect (ASD) in setting of pulmonary hypertension is complex. In the era of pulmonary arterial vasodilator therapy, every patient should undergo evaluation by pulmonary hypertension experts especially if defect closure is being considered. Defect closure in the inappropriate group can lead to poor outcomes.

Heparin Versus Bivalirudin in ST-Segment Elevation Myocardial Infarction: A SCAI-Based National Survey From US Interventional Cardiologists.

BACKGROUND: The use of antithrombotic therapy (ATT) (bivalirudin or unfractionated heparin) is a class I recommendation for patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). This survey was conducted to better understand current United States (US) practices in terms of preferences regarding the selection of ATT in STEMI-PPCI, particularly in light of recent clinical trials. METHODS: An electronic survey consisting of 9 focused questions was forwarded to 2676 US interventional cardiologists who were members of the Society for Cardiovascular Angiography and Interventions (SCAI). RESULTS: Among 390 responders (14.5%), bivalirudin with bail-out glycoprotein IIb/IIIa inhibitor (GPI) was the predominant strategy for 53% of operators, whereas 32% preferred heparin with bail-out GPI and 15% preferred heparin with more routine GPI. The duration of bivalirudin infusion varied widely among operators, and significant variability existed in the bolus dose of heparin that was preferred by operators. About 49% of respondents stated that the choice of ATT was not affected by the bleeding risk of the patient, although access site did appear to affect the choice of ATT for some operators. Notably, 43% of operators reported to have changed their practice regarding ATT in light of recent trial results. CONCLUSION: There is marked variability in self-reported ATT use in STEMI-PPCI among US interventional cardiologists. Given the patient-related variability in bleeding risk and mixed clinical trial results between the two predominant ATT agents, bivalirudin and unfractionated heparin, more data are needed in order to further inform and potentially unify clinical practice in STEMI-PPCI.

Transcatheter Aortic Valve Replacement Complication Rates in Teaching Vs Non-Teaching Centers in the United States.

OBJECTIVE: The objective of our study is to compare transcatheter aortic valve replacement (TAVR) complication rates among teaching vs non-teaching centers in the United States. METHODS: Using National Inpatient Sample (NIS) data, the largest all-payer database of hospital inpatient stay available in the United States, we identified patients (age ≥18 years) who underwent TAVR from January-December 2012. We constructed multivariable models to determine independent predictors (age, sex, race, Charlson's comorbidity index, hospital size, hospital location, and TAVR approach) of TAVR-associated complications. RESULTS: We identified 7405 TAVR procedures performed in the United States in 2012. In all, 88% of TAVRs were performed in teaching centers. There was no difference in mortality following TAVR between teaching and non-teaching centers. In-hospital complication rate was lower in teaching centers vs non-teaching centers (42% vs. 50%, respectively; P<.001). In adjusted analysis, hemorrhage requiring transfusion (13.2% vs. 20.8%; P<.001), renal complications requiring dialysis (1.2% vs. 2.3%; P<.01), respiratory complications (7.5% vs. 11%; P<.001), and complications requiring open-heart surgery (2% vs. 4.6%; P<.001) were lower in teaching centers vs non-teaching centers. Vascular access-site, pacemaker insertion, pericardial, and neurological complications were similar between teaching and non-teaching centers. CONCLUSION: Institutional design impacts TAVR complications, albeit with no difference in mortality. In general, complication rates are lower in teaching centers compared with non-teaching centers.

Femoral arterial closure using ProGlide® is more efficacious and cost-effective when ambulating early following cardiac catheterization.

OBJECTIVE: This was a prospective, single-center study evaluating the efficacy and cost-effectiveness of early ambulation (within 30 min) following femoral artery closure with the ProGlide® suture-mediated vascular closure device (PD) in patients undergoing diagnostic cardiac catheterization compared with manual compression. BACKGROUND: It is unclear whether early ambulation with ProGlide is safe or is associated with patient satisfaction and cost savings as compared with manual compression (MC). METHODS AND RESULTS: Inclusion criteria were met in 170 patients (85 PD and 85 MC patients). Patients ambulated 20 ft. within 30 min (PD) or after the requisite 4 h recumbent time (MC) if feasible. Primary endpoint was time-to-ambulation (TTA) following device closure. We also directly compared the safety of closure, times-to-hemostasis (TTH), -ambulation (TTA) and -discharge (TTD) with MC and, using a fully allocated cost model, performed cost analysis for both strategies. Multivariate analysis was used to determine predictors of patient satisfaction. The primary endpoint of safe, early ambulation was achieved following closure (mean of 27.1 ± 14.9 min; 95% confidence interval [CI] 25.2-30.2). Predictors of patient satisfaction in the PD group were absence of pain during closure, decreased TTA, and drastic reductions in TTD; the latter contributed indirectly to significant cost savings in the PD group (1250.3 ± 146.4 vs. 2248.1 ± 910.2 dollars, respectively; P < 0.001) and incremental cost savings by strategy also favored closure over MC ($84,807). CONCLUSIONS: ProGlide is safe and effective for femoral artery closure in patients who ambulate within 30 min after cardiac catheterization; translating into improved patient satisfaction and substantial cost savings.

Effect of the stop-flow technique on cardiac retention of c-kit positive human cardiac stem cells after intracoronary infusion in a porcine model of chronic ischemic cardiomyopathy.

It is commonly thought that the optimal method for intracoronary administration of cells is to stop coronary flow during cell infusion, in order to prolong cell/vascular wall contact, enhance adhesion, and promote extravasation of cells into the interstitial space. However, occlusion of a coronary artery with a balloon involves serious risks of vascular damage and/or dissection, particularly in non-stented segments such as those commonly found in patients with heart failure. It remains unknown whether the use of the stop-flow technique results in improved donor cell retention. Acute myocardial infarction was produced in 14 pigs. One to two months later, pigs received 10 million indium-111 oxyquinoline (oxine)-labeled c-kit(pos) human cardiac stem cells (hCSCs) via intracoronary infusion with (n = 7) or without (n = 7) balloon inflation. Pigs received cyclosporine to prevent acute graft rejection. Animals were euthanized 24 h later and hearts harvested for radioactivity measurements. With the stop-flow technique, the retention of hCSCs at 24 h was 5.41 ± 0.80 % of the injected dose (n = 7), compared with 4.87 ± 0.62 % without coronary occlusion (n = 7), (P = 0.60). When cells are delivered intracoronarily in a clinically relevant porcine model of chronic ischemic cardiomyopathy, the use of the stop-flow technique does not result in greater myocardial cell retention at 24 h compared with non-occlusive infusion. These results have practical implications for the design of cell therapy trials. Our observations suggest that the increased risk of complications secondary to coronary manipulation and occlusion is not warranted.

Safety of intracoronary infusion of 20 million C-kit positive human cardiac stem cells in pigs.

BACKGROUND: There is mounting interest in using c-kit positive human cardiac stem cells (c-kit(pos) hCSCs) to repair infarcted myocardium in patients with ischemic cardiomyopathy. A recent phase I clinical trial (SCIPIO) has shown that intracoronary infusion of 1 million hCSCs is safe. Higher doses of CSCs may provide superior reparative ability; however, it is unknown if doses >1 million cells are safe. To address this issue, we examined the effects of 20 million hCSCs in pigs. METHODS: Right atrial appendage samples were obtained from patients undergoing cardiac surgery. The tissue was processed by an established protocol with eventual immunomagnetic sorting to obtain in vitro expanded hCSCs. A cumulative dose of 20 million cells was given intracoronarily to pigs without stop flow. Safety was assessed by measurement of serial biomarkers (cardiac: troponin I and CK-MB, renal: creatinine and BUN, and hepatic: AST, ALT, and alkaline phosphatase) and echocardiography pre- and post-infusion. hCSC retention 30 days after infusion was quantified by PCR for human genomic DNA. All personnel were blinded as to group assignment. RESULTS: Compared with vehicle-treated controls (n=5), pigs that received 20 million hCSCs (n=9) showed no significant change in cardiac function or end organ damage (assessed by organ specific biomarkers) that could be attributed to hCSCs (P>0.05 in all cases). No hCSCs could be detected in left ventricular samples 30 days after infusion. CONCLUSIONS: Intracoronary infusion of 20 million c-kit positive hCSCs in pigs (equivalent to ~40 million hCSCs in humans) does not cause acute cardiac injury, impairment of cardiac function, or liver and renal injury. These results have immediate translational value and lay the groundwork for using doses of CSCs >1 million in future clinical trials. Further studies are needed to ascertain whether administration of >1 million hCSCs is associated with greater efficacy in patients with ischemic cardiomyopathy.

Transcatheter closure of five atrial septal communications in the presence of severe pulmonary arterial hypertension and severe left ventricular non-compliance.

Closure of congenital atrial communications in the presence of either severe pulmonary arterial hypertension (PAH) with pulmonary-to-systemic (right-to-left) shunting, or severe left ventricular (LV) non-compliance with left-to-right shunting is often considered prohibitive. Thus, the recognition of durable reversibility of these physiologic conditions is crucial. We describe a hemodynamic conundrum in a patient with five septal communications in whom the coexistence of unmasked bidirectional physiologic shunting, severe PAH, and worsening left-sided overload dissuaded initial closure. We report our strategy for hemodynamic evaluation and successful closure of all defects.

Transcatheter aortic valve replacement: focus on sex-related differences in outcomes.

Transcatheter aortic valve replacement (TAVR) has transformed the management of severe aortic stenosis for high-risk and inoperable patients. The 10-year experience in Europe has proven the technology to be safe and effective in select populations. The PARTNER trial, the first prospective, randomized, controlled trial for TAVR, showed the technology to be superior to medical management for inoperable patients and equivalent to surgical aortic valve replacement for high-risk patients. Research in cardiovascular medicine has been dominated by studies on the male sex, due to the incidence of the disease process and partly due to historic predominance of male subjects in research studies. Alternatively, TAVR studies focused on high-risk and inoperable patients who are equally distributed by sex. Although sex-related differences are apparent in their baseline characteristics, outcomes have been mixed, with evidence suggesting that female patients may have a mortality advantage with TAVR. Herein we review the TAVR procedure and devices currently available and focus our discussion on outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis.

Predictors and clinical impact of pre-existing and acquired thrombocytopenia following transcatheter aortic valve replacement.

BACKGROUND: Data are limited regarding transcatheter aortic valve replacement (TAVR)-related thrombocytopenia (TP). We sought to thoroughly characterize the presence, clinical impact, and severity of TP associated with TAVR. METHODS AND RESULTS: Data were collected from 90 patients who underwent TAVR using the Edwards SAPIEN valve (59 TF, 29 TA, 2 Tao). Platelet counts were evaluated peri-procedurally and for 8 days following TAVR. Platelet levels were compared and patients were divided into a no TP (No-TP) group 1, acquired (new) TP (NTP) group 2, pre-existing (pre-TAVR) TP (PTP) group 3, and further stratified based on the severity of TP: mild (M) TP (100-149 × 10(3) cell/µL) and moderate-severe (MS) TP (<100 × 10(3) cell/µL). Pre-TAVR point prevalence and post-TAVR incidence of TP were 40% and 79%, respectively (P < 0.001); nadir platelet count in all groups occurred day 4 post-TAVR. Baseline predictors for developing MS TP in groups 2-3 included baseline TP, leaner body mass, smaller pre-procedural aortic valve area, higher peak aortic jet velocity, and worsening baseline renal function. Development of "major" TP (nadir platelet count <100 × 103 cell/µL, ≥50% decrease) predicted a higher risk of major vascular complications (OR 2.78 [95% CI, 1.58-3.82]) and major bleeding (OR 3.18 [95% CI, 1.33-5.42]) in group 3. CONCLUSION: TAVR-related TP is predictable and classification by PTP and TP severity prior to TAVR allows for better risk stratification in predicting in-hospital clinical outcomes. Major TP in the presence of worsening TP is predictable and is associated with worse clinical outcomes. © 2014 Wiley Periodicals, Inc.