Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study.

BACKGROUND: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI. METHODS: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality. RESULTS: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001). CONCLUSIONS: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.

AIMS: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV). METHODS AND RESULTS: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days). CONCLUSIONS: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.

The Impella CP device for acute mechanical circulatory support in refractory cardiac arrest.

INTRODUCTION: Mechanical circulatory support may be considered as a therapeutic option in selected patients with refractory cardiac arrest (rCA). Animal studies suggest a potential role for the Impella® left ventricular assist device in this setting, but so far no human data have been published. METHODS: Eight patients with rCA were treated with the Impella CP® device at our institution from November 2014 to October 2015. The Impella CP® was used at the discretion of the treating physicians in patients with rCA and pulseless electrical activity with presumed primary left ventricular failure. These patients were compared to 12 patients with cardiogenic shock also treated with the Impella device during the same period. RESULTS: All cardiac arrests were witnessed with a no-flow time of 0min, six in-hospital and two out-of-hospital. Low-flow time was 50±52min (SD). The Impella device was successfully inserted in all patients with rCA and circulation was re-established. Survival rate to hospital discharge with good neurological outcome was similar among patients with rCA and cardiogenic shock treated with the Impella device (50% vs. 58%). Major vascular complications after Impella insertion occurred more frequently among patients with rCA compared to patients with cardiogenic shock (50% vs. 0%, P<0.05). CONCLUSION: Mechanical support with the Impella CP® device is a feasible and promising treatment option for selected patients with rCA. Further studies are warranted to determine the full potential and optimal patient selection compared to other modalities of mechanical circulatory support.