Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. Circulation. 2020 May 21;: Authors: Strom JB, Faridi KF, Butala NM, Zhao Y, Tamez H, Valsdottir LR, Brennan JM, Shen C, Popma JJ, Kazi DS, Yeh RW Abstract Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. Methods: We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016. Primary (e.g. death and stroke) and secondary trial endpoints, were compared across treatment arms (e.g. TAVR vs. SAVR) using trial-adjudicated outcomes versus outcomes derived from claims at 1-year (HiR) or 2-years (SURTAVI). Results: Among 600 linked CoreValve HiR participants (linkage rate 80.0%), the rate of the trial's primary endpoint of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1-year using both trial data (HR 0.84, 95% CI 0.65-1.09; p= 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80). Noninferiority ...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research

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ConclusionsPatients with cardiogenic shock can safely undergo LTHS dLVAD implantation after stabilization with ECMO or IABP. Outcomes and complications in these patients were comparable to a less severely ill cohort without tMCS.
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
AbstractSpinal cord infarction (SCI) is a rare disease among central nervous system vascular diseases. Only a little is known about venoarterial extracorporeal membrane oxygenation (VA-ECMO)-related SCI. Retrospective observational study conducted, from 2006 to 2019, in a tertiary referral center on patients who developed VA-ECMO-related neurovascular complications, focusing on SCI. During this period, among the 1893 patients requiring VA-ECMO support, 112 (5.9%) developed an ECMO-related neurovascular injury: 65 (3.4%) ischemic strokes, 40 (2.1%) intracranial bleeding, one cerebral thrombophlebitis (0.05%) and 6 (0.3%) sp...
Source: Journal of Artificial Organs - Category: Transplant Surgery Source Type: research
AbstractAimsThe aim of this study was to determine the incidence, predictors, and short ‐term and long‐term outcomes associated with in‐hospital sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) collectively termed ventricular arrhythmia (VA) in the heart failure (HF) patients.Methods and resultsThe HEart function Assessment Registry Trial in Saudi Arabia (HEARTS registry) is a prospective national registry of patients with chronic HF from18 tertiary care hospitals across Saudi Arabia. Diagnosis of HF was in accordance with American Heart Association/European Society of Cardiology definition cr...
Source: ESC Heart Failure - Category: Cardiology Authors: Tags: Original Research Article Source Type: research
AbstractIntroductionThe outcomes of transfemoral (TF) compared with transapical (TA) access for transcatheter aortic valve replacement (TAVR) in diabetics are unknown.MethodsWe queried the NIS database (2011 –2014) to identify diabetics who underwent TAVR. We performed a propensity matching analysis comparing TF-TAVR versus TA-TAVR.ResultsThe analysis included 14.555 diabetics who underwent TAVR. After matching, in-hospital mortality was not different between TF-TAVR and TA-TAVR. (3.5 vs. 4.4%,p = 0.11). TF-TAVR was associated with lower rates of cardiogenic shock (2.7 vs. 4.7%,p = 0.02), ...
Source: Cardiology and Therapy - Category: Cardiology Source Type: research
In conclusion, temporary VAD with CentriMag support is an effective treatment for patients in refractory cardiogenic shock. Despite its side effect, profile including a high rate of blood transfusion early in the immediate postoperative period of CentriMag support, aggressive use of the CentriMag support device has acceptable survival to discharge and 1 year survival.
Source: ASAIO Journal - Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
CONCLUSION: Mortality in CS patients due to decompensated severe AS is high, regardless of interventional treatment strategy. Both eBAV and eTAVR seem feasible. As eTAVR is associated with better initial improvements in hemodynamics and simultaneously avoids sequential interventions, it might be favorable to eBAV in select patients. If eTAVR is not available, eBAV might serve as a "bridge" to elective TAVR. PMID: 31611428 [PubMed - as supplied by publisher]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
ConclusionsIn this observational analysis of STEMI patients who underwent primary percutaneous coronary intervention, ticagrelor was associated with improved outcomes compared with clopidogrel and prasugrel. An appropriately powered randomized trial is needed to confirm these findings.RésuméContexteIl n’existe pas d’analyse robuste comparant les inhibiteurs P2Y12 à prise orale (clopidogrel, prasugrel et ticagrélor) chez les patients ayant subi un infarctus du myocarde avec élévation du segment ST (STEMI) traités par une intervention coronaire percutanée (I...
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
CONCLUSION: Although veno-arterial extracorporeal membrane oxygenation can improve the survival, it is associated with morbidity. Therefore, risk-benefit analysis for veno-arterial extracorporeal membrane oxygenation and prevention of complications are important to improve prognosis. PMID: 31394965 [PubMed - as supplied by publisher]
Source: The International Journal of Artificial Organs - Category: Transplant Surgery Authors: Tags: Int J Artif Organs Source Type: research
This article discusses patient assessment and management with anticoagulation, sedation, ventilation, and nutrition. Complications may occur, including bleeding, hemolysis, infection, acute kidney injury, stroke, left ventricular distention, limb ischemia, and upper body hypoxia. Patients may recover enough myocardial function to be weaned from ECMO or may be transitioned to a ventricular assist device or transplant. Quality of life may be affected by VA ECMO but may be no different than patients with other chronic health issues.
Source: Critical Care Nursing Clinics of North America - Category: Nursing Authors: Source Type: research
ConclusionsIn this observational analysis of STEMI patients undergoing PPCI, ticagrelor was associated with improved outcomes compared to clopidogrel and prasugrel. An appropriately powered randomized trial is needed to confirm these findings.
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
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