Smoking and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: a substudy from the randomized TROPICAL-ACS trial.

AIMS: Prior analyses disclosed variations in antiplatelet drug response and clinical outcomes between smokers and non-smokers, thus the safety and efficacy of any dual antiplatelet therapy (DAPT) de-escalation strategy may differ in relation to smoking status. Hence, we assessed the impact of smoking on clinical outcomes and adenosine diphosphate-induced platelet aggregation following guided de-escalation of DAPT in invasively managed acute coronary syndrome (ACS) patients. METHODS AND RESULTS: The multicentre TROPICAL-ACS trial randomized 2610 biomarker-positive ACS patients 1:1 to standard treatment with prasugrel for 12 months (control group) or a platelet function testing guided de-escalation of DAPT. Current smokers (n = 1182) showed comparable event rates between study groups [6.6% vs. 6.6%; hazard ratio (HR) 1.0, 95% confidence interval (CI) 0.64-1.56, P > 0.99]. In non-smokers (n = 1428), a guided DAPT de-escalation was associated with a lower 1-year incidence of the primary endpoint [cardiovascular death, myocardial infarction, stroke, or bleeding ≥ Grade 2 according to Bleeding Academic Research Consortium (BARC) criteria] compared with control group patients (7.9% vs. 11.0%; HR 0.71, 95% CI 0.50-0.99, P = 0.048). This reduction was mainly driven by a lower rate of BARC ≥ Grade 2 bleedings (5.2% vs. 7.7%; HR 0.68, 95% CI 0.45-1.03, P = 0.066). There was no significant interaction of smoking status with treatment effects of guided DAPT de-escalation (Pint = 0.23). Adenosine diphosphate-induced platelet aggregation values were higher in current smokers [median 28 U, interquartile range (IQR: 20-40)] vs. non-smoker [median 24 U (16-25), P < 0.0001] in the control group and in current smokers [median 42 U, IQR (27-68)] vs. non-smoker [median 37 U, IQR (25-55), P < 0.001] in the monitoring group. CONCLUSION: Guided DAPT de-escalation appears to be equally safe and effective in smokers and non-smokers. Regardless of smoking status and especially for those patients deemed unsuitable for 1 year of potent platelet inhibition this DAPT strategy might be used as an alternative antiplatelet treatment regimen.

Transcatheter aortic valve implantation (TAVI) by centres with and without an on-site cardiac surgery programme: preliminary experience from the German TAVI registry.

AIMS: To analyse patient characteristics, decision-making processes, and outcomes of TAVI performed in hospitals with versus those without on-site cardiac surgery (CS). METHODS AND RESULTS: Current guidelines mandate transcatheter aortic valve implantation (TAVI) to be performed at hospitals with both cardiology and on-site CS departments. Some hospitals in Germany perform TAVI without CS departments in-house. We analysed the data of 1,432 patients enrolled in the German TAVI registry at 27 hospitals between January 2009 and June 2010. Nineteen of these had on-site CS (group 1), while eight centres performed TAVI with no CS department at their institution (group 2). Patients in group 2 (n=178, 12% of the overall study population) were older than in group 1 (mean age 82.6±6.3 years vs. 81.6±6.2 years) with similar logistic EuroSCORE (average: 21%). Patients in group 2 were haemodynamically more stable (higher blood pressures, better ejection fraction, less low-flow or low-gradient aortic stenosis, and less urgent procedures). Procedure times and use of contrast were higher in group 2. The procedural success rate was higher in group 1 (98% vs. 95%). Post-procedural complications were similar in the two groups with 30-day mortality of 6.2% in group 2 compared with 8.3% in group 1 patients. CONCLUSIONS: Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.

Outcome of patients after emergency conversion from transcatheter aortic valve implantation to surgery.

AIMS: To evaluate: 1) the causes of emergency conversion from transcatheter aortic valve implantation (TAVI) to surgery, 2) procedural settings, and 3) short-term outcome of converted patients. METHODS AND RESULTS: The prospective German TAVI registry was used to identify patients who underwent bail-out surgery during TAVI. Additionally, standardised questionnaires were developed and used to assess more detailed periprocedural and postprocedural data. Emergency conversion from TAVI to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Primary conversion causes were aorto-valvular complications (i.e., aortic annulus rupture, aortic perforation, or thoracic aortic dissection). This was followed by prosthesis embolisation, myocardial perforation, severe aortic regurgitation, and coronary obstructions. The mean time interval between abortions of TAVI to surgery was 19 minutes (SD ± 17 min, range 5-80 min). Four of 24 patients (16.7%) died during the initial surgery, seven of 24 (29.2%) within the first 72 hours and the 30-day mortality was 45.8%. The highest mortality was observed in patients with aortic perforation or dissection (4/5, 80%). Mortality rates for other entities were: prosthesis embolisation 40% (2/5), myocardial perforation 50% (2/4), annulus rupture 67% (2/3), severe aortic regurgitation 33% (1/3), and coronary impairment 0% (0/3). CONCLUSIONS: Emergency conversion from TAVI to surgery is a rare event carrying a mortality of around 45% after 30 days. Outcome of converted patients with prior injury of aortic, aorto-valvular, or myocardial tissue during TAVI was poor, whereas patients with severe aortic regurgitation and those with coronary complications had a more favourable outcome after 30 days. Collected procedural and outcome data demand on-site cardiac surgery as a prerequisite for TAVI and constant process optimisation efforts regarding such emergency scenarios.

Percutaneous closure of perivalvular leaks with Amplatzer occluders: feasibility, safety, and shortterm results.

BACKGROUND AND AIM OF THE STUDY: Perivalvular leak (PVL) may have significant hemodynamic and/or hematological consequences, and re-do surgery is associated with considerable mortality and morbidity. Herein are reviewed the short-term results of percutaneous closure of PVLs using the Amplatzer occluder. METHODS: Eleven patients (five males, six females; mean age 59.7 +/- 7.3 years; range: 46-67 years) were referred for percutaneous closure of PVL using the Amplatzer occluder. Patients presented with congestive heart failure (n = 2), hemolysis (n = 1), or both (n = 8). The average number of previous heart operations was 2.4 +/- 1.3 per patient; seven patients had undergone two or more operations. The procedure was performed under general anesthesia, with fluoroscopic and transesophageal echocardiographic guidance. Antegrade and retrograde approaches were used for the mitral and aortic leaks, respectively. RESULTS: The PVLs were in the mitral position (n = 8), aortic position (n = 1), or both (n = 2). Device deployment was achieved in 11 (91.7%) of 12 attempted valves (10 patients, 90.9%). Failure to cross the leak with the wire occurred in one patient, and interruption of mitral leaflet movement occurred in two patients. Leakage was decreased in six patients (60%), but residual leak was observed at 10 of the 11 sites. Hemolysis was reduced in four patients, increased in four, and remained unchanged in two. An improved NYHA functional class of one grade was noted in five patients. One patient required a second operative session to seal a residual leak. CONCLUSION: Percutaneous closure of PVL using the Amplatzer occluder is feasible, but technically demanding. Although symptoms were improved, there was an inconsistent effect on hemolysis. At present, the Amplatzer occluder should be reserved for poor surgical candidates.