Mortality associated with acute respiratory distress syndrome, 2009-2019: a systematic review and meta-analysis.

Background: Acute respiratory distress syndrome (ARDS) occurs commonly in intensive care units. The reported mortality rates in studies evaluating ARDS are highly variable. Objective: To investigate mortality rates due to ARDS from before the 2009 H1N1 influenza pandemic began until the start of coronavirus disease 2019 (COVID-19) pandemic. Design: We performed a systematic search and then ran a proportional meta-analysis for mortality. We ran our analysis in three ways: for randomised controlled trials only, for observational studies only, and for randomised controlled trials and observational studies combined. Data sources: MEDLINE and Embase, using a highly sensitive criterion and limiting the search to studies published from January 2009 to December 2019. Review methods: Two of us independently screened titles and abstracts to first identify studies and then complete full text reviews of selected studies. We assessed risk of bias using the Cochrane RoB-2 (a risk-of-bias tool for randomised trials) and the Cochrane ROBINS-1 (a risk-of-bias tool for non-randomised studies of interventions). Results: We screened 5844 citations, of which 102 fully met our inclusion criteria. These included 34 randomised controlled trials and 68 observational studies, with a total of 24 158 patients. The weighted pooled mortality rate for all 102 studies published from 2009 to 2019 was 39.4% (95% CI, 37.0-41.8%). Mortality was higher in observational studies compared with randomised controlled trials (41.8% [95% CI, 38.9-44.8%] v 34.5% [95% CI, 30.6-38.5%]; P = 0.005). Conclusions: Over the past decade, mortality rates due to ARDS were high. There is a clear distinction between mortality in observational studies and in randomised controlled trials. Future studies need to report mortality for different ARDS phenotypes and closely adhere to evidence-based medicine. PROSPERO registration: CRD42020149712 (April 2020).

Adherence to blood product transfusion guidelines-An observational study of the current transfusion practice in a medical intensive care unit.

BACKGROUND: Blood transfusions though life-saving are not entirely benign. They are the most overused procedure in the hospital and have been under scrutiny by the 'Choosing Wisely campaign'. The strict adoption of restrictive transfusion guidelines could improve patient outcomes while reducing cost. OBJECTIVES: In this study, we evaluate adherence to restrictive transfusion guidelines, along with hospital mortality and length of stay (LOS) in transfusion events with a pre-transfusion haemoglobin (Hb) ≥7 g/dl. Additionally, we evaluated associated costs accrued due to unnecessary transfusions. METHODS: We conducted a retrospective observational study in a 64-bed medical intensive care unit (MICU) of an academic medical centre involving all adult patients (N = 957) requiring packed red blood cell transfusion between January 2015 and December 2015. RESULTS: In total, 3140 units were transfused with a mean pre-transfusion Hb of 6.75 ± 0.86 g/dl. Nine hundred forty-four (30%) transfusion events occurred with a pre-transfusion Hb ≥7 g/dl, and 385 (12.3%) of these occurred in patients without hypotension, tachycardia, use of vasopressors, or coronary artery disease. Forgoing them could have led to a savings of approximately 0.3 million dollars. Transfusion events with pre-transfusion Hb ≥7 g/dl were associated with an increased mortality in patients with acute blood loss (odds ratio [OR] 2.08, 95% confidence interval [CI] 1.11-3.88; p = 0.02) and LOS in patients with chronic blood loss (ß1 .8.26, 95% CI 4.09-12.43; p < 0.01). CONCLUSION: A subset of anaemic patients in the MICU still receive red blood cell transfusions against restrictive guidelines offering hospitals the potential for effective intervention that has both economic and clinical implications.

Coronary artery aneurysms: outcomes following medical, percutaneous interventional and surgical management.

BACKGROUND: Coronary artery aneurysms (CAAs) are increasingly diagnosed on coronary angiography; however, controversies persist regarding their optimal management. In the present study, we analysed the long-term outcomes of patients with CAAs following three different management strategies. METHODS: We performed a retrospective review of patient records with documented CAA diagnosis between 2000 and 2005. Patients were divided into three groups: medical management versus percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We analysed the rate of major cardiovascular and cerebrovascular events (MACCEs) over a period of 10 years. RESULTS: We identified 458 patients with CAAs (mean age 78±10.5 years, 74.5% men) who received medical therapy (N=230) or underwent PCI (N=52) or CABG (N=176). The incidence of CAAs was 0.7% of the total catheterisation reports. The left anterior descending was the most common coronary artery involved (38%). The median follow-up time was 62 months. The total number of MACCE during follow-up was 155 (33.8%); 91 (39.6%) in the medical management group vs 46 (26.1%) in the CABG group vs 18 (34.6%) in the PCI group (p=0.02). Kaplan-Meier survival analysis showed that CABG was associated with better MACCE-free survival (p log-rank=0.03) than medical management. These results were confirmed on univariate Cox regression, but not multivariate regression (OR 0.773 (0.526 to 1.136); p=0.19). Both Kaplan-Meier survival and regression analyses showed that dual antiplatelet therapy (DAPT) and anticoagulation were not associated with significant improvement in MACCE rates. CONCLUSION: Our analysis showed similar long-term MACCE risks in patients with CAA undergoing medical, percutaneous and surgical management. Further, DAPT and anticoagulation were not associated with significant benefits in terms of MACCE rates. These results should be interpreted with caution considering the small size and potential for selection bias and should be confirmed in large, randomised trials.

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

BACKGROUND: The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker. METHODS: We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve. RESULTS: Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; P<0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (P=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; P<0.001), as were rates of complete heart block (3.5% versus 11.2%; P<0.001) and new-onset left bundle branch block (5.3% versus 12.2%; P<0.001). There were no differences in mild (16.5% versus 15.9%; P=0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; P=0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; P=0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; P=0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; P=0.772). CONCLUSIONS: Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.

Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience.

BACKGROUND: Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA). METHODS: We included consecutive patients who underwent transfemoral-TAVR at our institution between January 2012 and April 2017. We compared outcomes with GA versus MAC. RESULTS: Of 998 patients, MAC was used in 43.9%. MAC was associated with shorter procedural time (96.9 ± 30.9 vs. 135 ± 64.6 mins; p < .001), fluoroscopy time (20.4 ± 8.9 vs. 29 ± 18.7 mins; p < .001), lower contrast volume (45.5 ± 27 vs. 60.4 ± 43 cc; p < .001), and decreased radiation exposure (12,869 ± 8,099 vs. 20,630 ± 16,276 cGy-cm2 ; p < .001). Patients who underwent MAC had a briefer median (IQR) intensive care unit stay [23.3 (21-24) vs. 23.4 (20.8-26) hrs; p < .001], and hospital stay [2 (2, 3) vs. 3 (2-6) days; p < .001], and were more frequently discharged to home (93.4% vs. 82.9%; p < .001). MAC was associated with lower mortality at 30 days (0.5% vs. 2.9%; log-rank p = .012; adjHR 0.22, 95% CI 0.06-0.82; p = .024), but not at 1 year (11.7% vs. 14.6%; log-rank p = .157) or 3 years (36.8% vs. 38.4%; log-rank p = 0.433). There were no differences in major adverse cardiac and cerebrovascular events (MACCE) at either 30 days (4.6% vs. 9.3%; log-rank p = .14) or 1 year (21.1% vs. 21.5%; log-rank p = .653). Similar findings were seen among patients who received newer-generation SAPIEN-3 valves. CONCLUSION: Utilizing MAC and omitting intraprocedural transesophageal echocardiography during TAVR seems to be more efficient without compromising safety. Better TAVR outcomes can be achieved with newer generation valves without needing GA.

Impact of baseline conduction abnormalities on outcomes after transcatheter aortic valve replacement with SAPIEN-3.

BACKGROUND: Baseline conduction abnormalities are known risk factors for permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). We sought to determine the impact of baseline right bundle branch block (RBBB), left bundle branch block (LBBB), left anterior hemiblock (LAHB), first-degree atrioventricular block (AVB) and atrial fibrillation/flutter (AF) on TAVR outcomes. METHODS: Consecutive patients who underwent transfemoral TAVR with SAPIEN-3 (S3) were included. We excluded patients with prior PPM, nontransfemoral access or valve-in-valve. RESULTS: Among 886 patients, baseline RBBB was seen in 15.9%, LBBB in 6.3%, LAHB in 6.2%, first-degree AVB in 26.3% and AF in 37.5%. The rate of 30-day PPM was 10.1%. Baseline RBBB (OR 4.005; 95% CI 2.386-6.723; p < .001) and first-degree AVB (OR 1.847; 95% CI 1.133-3.009; p = .014) were independent predictors of 30 day PPM. LAHB also resulted in higher PPM rates but only in unadjusted analysis (21.8% vs. 9.4%; p = .003). Baseline LBBB and AF were associated with lower left ventricular ejection fraction (LVEF) at both baseline and 1 year after TAVR. However, Δ LVEF over time were noted to be similar with baseline LBBB (1.8% vs. 1.4%; p = .809) and AF (1.1% vs. 1.7%; p = .458). Moreover, baseline AF was also associated with higher stroke/transient ischemic attack (TIA) at 1 year (4.4% vs. 1.8%; p = .019), 1-year major adverse cardiac and cerebrovascular events (MACCE) (19.5% vs. 13.3%; p = .012) and 2 year mortality (23.5% vs. 15.2%; p = .016). None of the other baseline conduction defects affected long-term mortality or MACCE. CONCLUSION: In our S3 TAVR population, baseline RBBB and first-degree AVB predicted higher PPM risk. Prior LBBB and AF were associated with lower LVEF at both baseline and 1 year. Lastly, preexisting AF was associated with higher rates of mortality, stroke/TIA, and MACCE.

Impact of tricuspid regurgitation on postoperative outcomes after non-cardiac surgeries.

Objective: Tricuspid regurgitation (TR) severity has known adverse implications, its impact on patients undergoing non-cardiac surgery (NCS) remains unclear. We sought to determine the impact of TR on patient outcomes after NCS. Methods: We performed a retrospective cohort study in patients undergoing NCS. Outcomes in patients with moderate or severe TR were compared with no/trivial TR after adjusting for baseline characteristics and revised cardiac risk index (RCRI). The primary outcome was defined as 30-day mortality and heart failure (HF), while the secondary outcome was long-term mortality. Results: Of the 7064 patients included, 312 and 80 patients had moderate and severe TR, respectively. Thirty-day mortality was higher in moderate TR (adjusted OR 2.44, 95% CI 1.25 to 4.76) and severe TR (OR 2.85, 95% CI 1.04 to 7.79) compared with no/trivial TR. There was no difference in 30-day HF in patients with moderate TR (OR 1.48, 95% CI 0.90 to 2.44) or severe TR (OR 1.42, 95% CI 0.60 to 3.39). The adjusted HR for long-term mortality in moderate TR was 1.55 (95% CI 1.31 to 1.82) and 1.87 (95% CI 1.40 to 2.50) for severe TR compared with no/trivial TR. Conclusion: Increasing TR severity has higher postoperative 30-day mortality in patients undergoing NCS, independent of RCRI risk factors, ejection fraction or mitral regurgitation. Severity of TR should be considered in risk stratification for patients undergoing NCS.

Comparison of acute recoil after valve deployment and after post-dilation in patients undergoing transfemoral-transcatheter aortic valve replacement with SAPIEN-3 valve.

BACKGROUND: Transcatheter aortic valves are prone to acute recoil similar to the metal-based coronary stents. However, it is not clear if recoil remains a factor only after the initial valve deployment or also after post-dilation. METHODS: We conducted a retrospective observational study of patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with SAPIEN-3 valve. Acute recoil at the upper, central, and lower levels of the valve was calculated in both anteroposterior right anterior oblique (RAO) and lateral left anterior oblique (LAO) views after initial deployment as well as after post-dilation. The average recoil of the RAO and LAO views was also calculated and described as RAO/LAO. RESULTS: The acute recoil in the RAO/LAO views (mean ± SD) was 3.9 ± 1.1% after valve deployment in the whole study population (n = 257). Among the subset of patients who required post-dilation (n = 133), the mean acute recoil in the RAO/LAO views was found to be greater after initial valve deployment as compared with after post-dilation (3.8 ± 1.1% vs. 3.0 ± 0.9%; p < .001). Further, acute recoil was significantly greater in the RAO view than the LAO view and at the central level of the prosthesis as compared with the upper and lower levels. Those findings were consistent after initial deployment as well as after post-dilation. Clinical outcomes were similar between patients who required post-dilation compared to those who did not. In multivariable logistic regression analysis, only smaller valve cover index was found to be an independent predictor of 30-day mild or greater aortic regurgitation (OR 0.007; 95% CI 0.0001-0.707; p = .035). CONCLUSION: Acute elastic recoil of the SAPIEN-3 valve was significantly less after post-dilation as compared with after deployment. It was also greater when measured in the RAO view as compared with the LAO view. Furthermore, acute recoil was not homogenous across the height of the valve stent frame.

The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation.

OBJECTIVES: The aim of this study was to determine the utility of rapid atrial pacing immediately after transcatheter aortic valve replacement (TAVR) to predict the need for permanent pacemaker implantation (PPI). BACKGROUND: Risk stratification for patients without high-grade atrioventricular block (AVB) after TAVR is imprecise and based on anatomic considerations, electrocardiographic characteristics, and clinical suspicion. A more reliable assessment is necessary to minimize inpatient rhythm monitoring and/or reduce unnecessary PPI. METHODS: Consecutive patients undergoing TAVR at 2 centers were included. After valve implantation in patients without pacemakers who did not have complete heart block or atrial fibrillation, the temporary pacemaker was withdrawn from the right ventricle and placed in the right atrium. Rapid atrial pacing was performed from 70 to 120 beats/min, and patients were assessed for the development of Wenckebach AVB. Patients were then followed for clinical outcomes, including PPI. RESULTS: A total of 284 patients were included. Of these, 130 (45.8%) developed Wenckebach AVB. There was a higher rate of PPI within 30 days of TAVR among the patients who developed Wenckebach AVB (13.1% vs. 1.3%; p < 0.001), with a negative predictive value for PPI in the group without Wenckebach AVB of 98.7%. A greater percentage of patients receiving self-expanding valves required PPI than those receiving a balloon-expandable valves (15.9% vs. 3.7%; p = 0.001), though these rates were still relatively low among patients who did not develop Wenckebach AVB (2.9% and 0.8%). CONCLUSIONS: Atrial pacing post-TAVR is easily performed and can help identify patients who may benefit from extended rhythm monitoring. Patients who did not develop pacing-induced Wenckebach AVB demonstrated an extremely low likelihood of PPI.

Comparison of Rotational with Orbital Atherectomy During Percutaneous Coronary Intervention for Coronary Artery Calcification: A Systematic Review and Meta-Analysis.

BACKGROUND: Percutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant calcification. Procedural success and long-term outcomes after PCI have been worse in patients with severe coronary calcium. OBJECTIVE: A Bayesian meta-analysis of outcomes comparing rotational atherectomy (RA) with orbital atherectomy (OA) was performed. METHODS: PubMed, Embase, and Cochrane Library databases were searched through 30th November 2018 and identified 4 observational studies. RESULTS: The primary end-point, Major Adverse Cardiac Event (MACE) composing of death, MI and stroke at 1 year was more likely with RA (OR = 1.61; 95% CI: 1.11-2.33; p = 0.01) as compared to OA. The driver of the difference in MACE between the two groups was a statistically significant difference in mortality favoring OA (OR = 4.65; 95% CI: 1.36-15.87; p = 0.01). Peri-procedural MI, the other component of the primary end-point was 1.3 times more likely in the RA arm (OR = 1.35; 95% CI 0.95-1.92; p-0.09) and was not statistically different between the groups. The odds of a vascular complication were not different in the two groups (OR = 1.26; 95% CI: 0.73-2.17; p = 0.41). In an adjusted Bayesian analysis, mortality (OR = 3.69; 95% CI: 0.30-38.51), MACE (OR = 1.68; 95% CI: 0.55-5.49), MI (OR = 1.42; 95% CI: 0.50-4.29) and dissections/perforations (OR = 0.38; 95% CI: 0.10-1.38) were not different in RA and OA groups. CONCLUSION: Our study is the first published Bayesian meta-analysis comparing MACE and peri-procedural outcomes in RA compared to OA. These findings lay the foundation for a randomized comparison between the two competing technologies.

Vancomycin Spacer-induced Hemolysis.

Intravenous vancomycin-induced hemolysis has been documented in the literature. This has been presumed to be due to the development of antibodies against additives that are added along with antibiotics. Herein, we present the case of a 72-year-old male who had hemolysis after the placement of vancomycin spacer, which improved after the spacer was removed.

Utilization and outcomes of polytetrafluoroethylene covered stents in patients with coronary artery perforation and coronary artery aneurysm: Single center 15-year experience.

OBJECTIVES: Determine the outcomes of polytetrafluoroethylene (PTFE) covered stents for coronary artery perforation (CAP) and coronary artery aneurysm (CAA). BACKGROUND: PTFE covered stents have been used for treatment of potentially life-threatening CAP and CAA. The short and long-term outcomes of the PTFE covered stent for CAP and CAA have not been well studied. METHODS: We performed a retrospective study of PTFE covered stents that were placed in the patients from 2003 to 2017. Short term outcomes included in-hospital mortality, pericardial effusion, cardiac tamponade, and length of stay. Long-term outcomes included target lesion revascularization (TLR), in-stent restenosis (ISR), and long-term mortality. RESULTS: Fifty-three PTFE covered stents were placed in 32 patients of which there were 24 patients with a CAP with a mean age of 75 ± 8 years. Two patients died in-hospital, with no additional deaths at 30 days. The rate of ISR was 25%, with estimated rates of TLR of 2.6% (3 years) and 17.8% (5 years). The median survival was 55.6 months, with survival at 10 years estimated to be 30.9%. Eight patients received a PTFE covered stent for CAA with a mean age of 59 ± 15 years with no in-hospital or 30-day mortality. Median follow-up of 49 months showed no evidence of TLR. The all-cause mortality was 12% at 1 year and 38% at 3 years. CONCLUSIONS: PTFE covered stents is an effective option in patients with CAP and CAA. The long-term outcomes may be related to the pathology of the disease rather than the stent itself.

Time-Integrated Aortic Regurgitation Index Helps Guide Balloon Postdilation During Transcatheter Aortic Valve Replacement and Predicts Survival.

Background Balloon postdilation ( BPD ) has emerged as an effective strategy to reduce paravalvular regurgitation ( PVR ) during transcatheter aortic valve replacement ( TAVR ). We investigated the utility of a time-integrated aortic regurgitation index ( TIARI ) to guide balloon postdilation ( BPD ) after valve deployment. Methods and Results All consecutive patients who had echocardiography, aortography, and hemodynamic tracings recorded immediately after valve deployment during TAVR were included in the study. Catheter-derived invasive hemodynamic parameters were calculated offline. Among 157 patients who underwent TAVR , 49 (32%) patients required BPD to reduce significant PVR after valve deployment. Two experienced operators decided whether the patients required BPD for significant PVR . Median TIARI measured immediately after valve deployment was significantly lower in patients who required BPD when compared with patients who did not require BPD ( P<0.001). In a multivariable analysis, lower TIARI (odds ratio: 0.81; P=0.003) and higher PVR grade on aortography and echocardiography ( P<0.001 for both) were associated with BPD . Adding TIARI to echocardiography and aortographic PVR assessment resulted in a significant increase in global χ2 ( P<0.001), an integrated discrimination index of 9% ( P=0.002), and combined C-statistics of 0.99 for predicting BPD . Higher TIARI after valve deployment was associated with better survival (hazard ratio: 0.94, P=0.014), while other hemodynamic and imaging parameters did not predict mortality after TAVR . Conclusions Among patients undergoing TAVR , a TIARI measured immediately after valve deployment adds incremental value to guide BPD over aortography and echocardiography. Higher residual TIARI is associated with better survival after TAVR .

Hemodynamic durability of transcatheter aortic valves using the updated Valve Academic Research Consortium-2 criteria.

OBJECTIVES: We investigated the hemodynamic durability of the transcatheter aortic valves (TAVs) using the updated Valve Academic Research Consortium-2 (VARC-2) criteria. BACKGROUND: The updated VARC-2 consensus criteria combine flow-dependent and flow-independent echocardiographic parameters for hemodynamic assessment of TAVR. Data on the hemodynamic durability of TAV and clinical risk factors associated with valve hemodynamic deterioration (VHD) are lacking. METHODS: All patients (n = 276) who received TAV between 2006 and 2012 and had ≥2 follow-up echocardiograms were studied. RESULTS: During a median follow up period of 3.3 (1.8-4.4) years, 8 patients (3%) developed moderate to severe valve stenosis per the VARC-2 criteria, while 20 had mild stenosis. In a Cox proportional hazards model analysis, moderate to severe stenosis by VARC-2 criteria was associated with younger age (P = 0.03, HR 0.94), absence of dual antiplatelet therapy (DAPT) (P = 0.026, HR 0.18), and lower baseline left ventricular ejection fraction (LVEF) (P = 0.006, HR 0.94). Longitudinal analysis using a mixed effect model showed that presence of stenosis by VARC-2 criteria was associated with an increase in aortic valve mean gradient (P < 0.001, +2.34 mmHg per year). In a subset of 93 patients with analyzable fluoroscopic images, deeper valve implantation was associated with increase in mean gradient (P = 0.004, +0.2 mmHg per year per 1 mm increase in implantation depth). CONCLUSION: Despite good hemodynamic durability of TAV, patients with younger age, lower LVEF and those not on DAPT after undergoing a TAV replacement, are at a higher risk for development of VHD.

Durability Data for Bioprosthetic Surgical Aortic Valve: A Systematic Review.

Importance: Although several studies have reported data on surgical aortic valve durability, variability in study methodologies and definitions as well as inadequate follow-up make the interpretation of data from these studies difficult to interpret. Objective: To review available data on structural valve deterioration (SVD) of surgical bioprosthetic aortic valves by examining the published literature as well as data reported to the US Food and Drug Administration (FDA). Evidence Review: A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines to obtain all available data from preexisting literature on the actuarial freedom from SVD and outcomes of SVD. Data were collected from database inception to November 2016. Additionally, data reported to the FDA were obtained. Findings: In total, 167 studies and 12 FDA reports including 101 650 patients and 17 different valve types were analyzed. There were 11 different definitions of SVD used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from less than 1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0% to 37% of patients remaining at risk at maximum follow-up. Food and Drug Administration-reported data are similarly variable in duration (mean follow-up range, 1.2 to 7 years) and completeness of follow-up, with final follow-up of 0.1% to 95%. Conclusions and Relevance: There is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate long-term systematically collected core laboratory data. Rigorously collected long-term data with standardized definitions for surgical valves are needed to provide a benchmark for the durability of rapidly evolving transcatheter valves.

Current Society of Thoracic Surgeons Model Reclassifies Mortality Risk in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The Society of Thoracic Surgeons (STS) scores are used to screen patients for transcatheter aortic valve replacement (TAVR). The STS scores were also used to risk stratify patients in major TAVR trials. This study evaluates the reclassification of predicted risk of mortality by the currently available online STS score calculator compared with the 2008 STS risk model in patients undergoing TAVR. METHODS AND RESULTS: All patients who underwent TAVR from 2006 to 2016 were included in the study. The STS scores for all included patients were calculated by applying the 2008 STS risk model and again using the current STS online calculator. Among 1209 patients who underwent TAVR, 30-day mortality was 27 (2.2%). The overall predicted risk of mortality estimated by using the current online STS risk calculator was significantly lower than the 2008 STS risk model (6.3±4.4 vs 7.3±4.9; P<0.001). A total of 235 (19%) patients were reclassified into a lower risk category per the current STS risk model. In a multivariable logistic regression analysis, patients with persistent atrial fibrillation (odds ratio, 1.4; 95% CI, 1.0-1.9; P=0.03), chronic heart failure (odds ratio, 6.0; 95% CI, 3.8-10.1; P<0.001), and New York Heart Association class IV heart failure (odds ratio, 2.4; 95% CI, 1.3-4.4; P=0.007) were more likely to be reclassified into a lower risk category per the current STS risk model. CONCLUSIONS: The current STS calculation method produces significantly lower predicted risk of mortality than the 2008 calculator, more pronounced in patients with certain comorbid conditions. These results should be considered while evaluating data from prior studies of TAVR.

Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation.

Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.

Utility of ankle-brachial index in screening for peripheral arterial disease in rural India: A cross-sectional study and review of literature.

BACKGROUND: Peripheral arterial disease (PAD) is an underdiagnosed illness often affecting the elderly population. Ankle brachial index (ABI) is a good diagnostic tool for PAD in outpatient practice, but remains underused. MATERIALS AND METHODS: Patients were recruited from an outpatient medical camp in rural India, and assessed for symptoms and pre-existing risk factors. Measured ABI≤0.9 was considered abnormal and considered PAD. RESULTS: Out of 100 patients recruited, PAD was diagnosed in 57 patients. Associated risk factors were like age >55years (67%), hypertension (66%), smoking (69%) and diabetes mellitus (35%) were common. CONCLUSION: PAD is a very common and underdiagnosed illness in rural India. A simple tool like ABI can help diagnosis in underserved areas.

Comparison of single versus dual antiplatelet therapy after TAVR: A systematic review and meta-analysis.

OBJECTIVE: We aim to evaluate the efficacy of dual versus single anti-platelet therapy (SAPT) after TAVR through a systematic review and meta-analysis of published research. BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is a commonly practiced strategy after transcatheter aortic valve replacement (TAVR). However, there is lack of sufficient evidence supporting this approach. METHOD: We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials (RCT) and observational studies comparing DAPT with SAPT post TAVR. Event rates were compared using a forest plot of relative risk with 95% confidence intervals using a random-effects model assuming inter-study heterogeneity. RESULTS: A total of six studies (3 RCTs and 3 observational studies, n = 840) were included in the final analysis. Compared to SAPT, DAPT was associated with increased risk of significant bleeding (life threatening and major) [RR = 2.52 (95% CI 1.62-3.92, P < 0.0001)] with the number needed to harm for major or life-threatening bleeding calculated to be 10.4. There was no significant difference in the incidence of stroke [RR = 1.06 (95% CI, 0.43-2.60, P = 0.90)], spontaneous myocardial infarction [RR = 2.08 (95% CI, 0.56-7.70, P = 0.27)] and all-cause mortality [RR = 1.18 (95% CI, 0.68-2.05, P = 0.56] in the DAPT and SAPT groups. CONCLUSION: In this small meta-analysis of DAPT versus SAPT after TAVR, DAPT did not prevent stroke, myocardial infarction or death while the risk of bleeding was higher. Results from ongoing trials are awaited to determine the best anti-thrombotic approach after TAVR.