Romain Chopard

Clinical Outcomes and Safety of Transfemoral Aortic Valve Implantation Under General Versus Local Anesthesia Subanalysis of the French Aortic National CoreValve and Edwards 2 Registry

Background—Transcatheter aortic valve implantation (TAVI) performed under local anesthesia (LA) is becoming increasingly common. We aimed to compare the clinical outcomes in patients who underwent transfemoral-TAVI under general anesthesia (GA) and LA. Methods and Results—Data from 2326 patients in the French Aortic National CoreValve and Edwards 2 (FRANCE 2) registry who underwent transfemoral-TAVI were analyzed. During the study period, the percentage of LA procedures increased gradually from 14% in January 2010 to 59% in October 2011. The clinical outcomes for GA (n=1377) and LA (n=949) were compared. Numerous baseline characteristics differed between the 2 groups, and the use of transesophageal echocardiographic guidance was more common in GA than in LA (76.3% versus 16.9%; P<0.001). Device success and cumulative 30-day survival rates were similar in the 2 groups (97.6% versus 97.0%; P=0.41 and 91.6% versus 91.3%; P=0.69, respectively), whereas the incidence of postprocedural aortic regurgitation≥mild was significantly lower in GA than in LA (15.0% versus 19.1%; P=0.015). The groups were also analyzed using a propensity-matching model, including transesophageal echocardiographic usage (GA [n=401] versus LA [n=401]). This model indicated that there were no significant differences between the 2 groups in the rates of 30-day survival (GA [91.4%] versus LA [89.3%]; P=0.27] and postprocedural aortic regurgitation≥mild (GA [12.7%] versus LA [16.2%]; P=0.19). Conclusions—The less invasive transfemoral-TAVI under LA is preferred in clinical settings and seems to be acceptable; however, the higher incidence of postprocedural aortic regurgitation is emphasized. Therapeutic efforts should be made to reduce such complications during transfemoral-TAVI under LA.

Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting).

Background: No randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of percutaneous coronary intervention (PCI) for non–ST-segment elevation acute coronary syndromes. Methods: We conducted a multicenter, randomized study involving 240 patients with non–ST-segment elevation acute coronary syndromes to compare OCT-guided PCI (use of OCT pre- and post-PCI; OCT-guided group) to fluoroscopy-guided PCI (angiography-guided group). The primary end point was the functional result of PCI assessed by the measure of post PCI fractional flow reserve. Secondary end points included procedural complications and type 4a periprocedural myocardial infarction. Safety was assessed by the rate of acute kidney injury. Results: OCT use led to a change in procedural strategy in 50% of the patients in the OCT-guided group. The primary end point was improved in the OCT-guided group, with a significantly higher fractional flow reserve value (0.94±0.04 versus 0.92±0.05, P=0.005) compared with the angiography-guided group. There was no significant difference in the rate of type 4a myocardial infarction (33% in the OCT-group versus 40% in the angiography-guided group, P=0.28). The rates of procedural complications (5.8%) and acute kidney injury (1.6%) were identical in each group despite longer procedure time and use of more contrast medium in the OCT-guided group. Post-PCI OCT revealed stent underexpansion in 42% of patients, stent malapposition in 32%, incomplete lesion coverage in 20%, and edge dissection in 37.5%. This led to the more frequent use of poststent overdilation in the OCT-guided group versus the angiography-guided group (43% versus 12.5%, P<0.0001) with lower residual stenosis (7.0±4.3% versus 8.7±6.3%, P=0.01). Conclusions: In patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher postprocedure fractional flow reserve than PCI guided by angiography alone. OCT did not increase periprocedural complications, type 4a myocardial infarction, or acute kidney injury. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01743274.

Baseline Characteristics and Prognostic Implications of Pre-Existing and New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: Results From the FRANCE-2 Registry.

OBJECTIVES The aim of this study was to determine baseline characteristics and clinical outcomes of patients with pre-existing atrial fibrillation (AF) and of patients who presented with new-onset AF after transcatheter aortic valve implantation (TAVI). BACKGROUND Little is known regarding the impact of AF after TAVI. METHODS The FRANCE-2 registry included all patients undergoing TAVI (N = 3,933) in France in 2010 and 2011. New-onset AF was defined as the occurrence of AF post-procedure in a patient with no documented history of AF. RESULTS AF was documented before TAVI in 25.8% of patients. New-onset AF was observed in 174 patients after TAVI among patients without a history of pre-existing AF (6.0%). At 1 year, the rates of all-cause death (26.5 vs. 16.6%, respectively; p < 0.001) and cardiovascular death (11.5 vs. 7.8%, respectively; p < 0.001) were significantly higher in patients with pre-existing AF compared with those without AF. Rehospitalization for worsening heart failure and New York Heart Association functional class was also higher in patients with pre-existing AF versus those without, resulting in a higher rate of combined efficacy endpoint in this group (p < 0.001). A history of stroke, surgical (nontransfemoral) approach, cardiological, and hemorrhagic procedure-related events were all independently related to the occurrence of new-onset post-procedural AF. New-onset AF in patients without pre-existing AF was associated with a higher rate of combined safety endpoint at 30 days (p < 0.001) and a higher rate of both all-cause death and combined efficacy endpoint at 1 year (p = 0.003 and p = 0.02, respectively). CONCLUSIONS Pre-existing and new-onset AF are both associated with higher mortality and morbidity after TAVI.

C-reactive protein improves risk prediction in patients with acute coronary syndromes

AIMS Elevated C-reactive protein level is a risk marker in patients with acute coronary syndromes (ACSs), but current risk score systems do not consider this factor. We studied the incremental predictive value of adding C-reactive protein to the Global Registry of Acute Coronary Events (GRACE) risk score. METHODS AND RESULTS Characteristics, treatments and 30-day mortality were recorded for 1408/1901 consecutive ACS patients. Changes in global model fit, discrimination, calibration, and reclassification were evaluated upon addition of C-reactive protein to the GRACE risk score. High-C-reactive protein patients (C-reactive protein >22 mg/L, 4th quartile of C-reactive protein) were older, had more comorbidities and worse haemodynamic conditions, received less recommended treatment, and had a four-fold higher 30 day mortality. Multivariable analysis demonstrated high-C-reactive protein as an important and independent predictor of mortality. Addition of high-C-reactive protein in the GRACE model modestly improved global fit, discriminatory capacity (c-statistic from 0.795 to 0.823), and calibration. Patients were divided into four groups according to GRACE risk score prediction: <1, 1 to <5, 5 to <10, and >or=10%. The model with high-C-reactive protein allowed adequate reclassification in 12.2%. CONCLUSION Elevated C-reactive protein level is a modest but independent predictive factor of 30-day mortality in ACS patients, even after adjustment for co-morbidities, haemodynamic conditions, and treatment. Combined with the GRACE risk score, C-reactive protein information improves risk classification.

Anemia for Risk Assessment of Patients With Acute Coronary Syndromes

In patients admitted with acute coronary syndromes, those with anemia are at higher risk. However, current risk score systems do not take into account the presence of anemia. The impact of anemia on mortality was studied, and its incremental predictive value was evaluated. Demographic, clinical, and biologic characteristics at admission, as well as treatments and mortality, were recorded for 1,410 consecutive patients with acute coronary syndromes. The incremental value of adding anemia information to risk score evaluation was determined using changes in the appropriateness of Cox models when anemia was added. Anemia was detected in 381 patients (27%). They were older, had more co-morbidities, had higher Global Registry of Acute Coronary Events (GRACE) risk scores, received fewer guideline-recommended treatments, and, as a result, had 4-fold higher mortality. When included in a prediction model based on the GRACE risk score, anemia remained an independent predictor of mortality. The addition of anemia improved both the discriminatory capacity and calibration of the models. According to the GRACE risk score, the population was divided into 4 groups of different risk levels of <1%, 1% to <5%, 5% to <10%, and > or =10%. The addition of anemia to the model made it possible to reclassify 9%, 43%, 47%, and 23% of patients into the different risk categories, respectively. In conclusion, our data confirmed that anemia was an independent predictive factor of mortality and had incremental predictive value to the GRACE score system for early clinical outcomes.

Evolution of acute coronary syndrome with normal coronary arteries and normal cardiac magnetic resonance imaging

BACKGROUND Acute coronary syndrome (ACS) with normal coronary angiography is a frequent clinical situation with an uncertain prognosis. Cardiac magnetic resonance imaging (CMRI) is a powerful tool for differential diagnosis between myocardial infarction (MI), acute myocarditis and Tako-tsubo cardiomyopathy (TTC). Data are sparse regarding the evolution of patients presenting an ACS with normal coronary arteries and normal CMRI. AIMS To evaluate the evolution of patients presenting an ACS with normal coronary arteries and normal CMRI, with a 1-year follow-up. METHODS Eighty-seven consecutive patients (mean age, 53 years; 40.2% men) presenting an ACS with troponin elevation and normal coronary arteries by angiography were prospectively included. All patients underwent CMRI at 3-Tesla. Adverse events were recorded with 1-year follow-up. RESULTS A likely aetiology for the acute clinical presentation was established by CMRI in 63.2% of patients (22.7% MI, 26.4% acute myocarditis, 11.5% TTC). During follow-up, one patient in the MI group had a stroke (1.2%). In the myocarditis group, there was one initial cardiogenic shock, one episode of congestive heart failure (1.2%) and nine patients had recurrent chest pain without troponin elevation (10.3%). Two TTC group patients initially presented with cardiogenic shock (2.4%); there were no other adverse events in this group during follow-up. In the remaining 36.7% patients, no clear diagnosis could be identified by CMRI, and no adverse events occurred during follow-up. CONCLUSION CMRI is a useful tool for the management of ACS presenting with normal coronary angiography, as it helps to ascertain the diagnosis and adapt treatment in a large proportion of cases. Nonetheless, patients with no abnormalities identified by CMRI have an excellent evolution.

Propensity score-matched analysis of effects of clinical characteristics and treatment on gender difference in outcomes after acute myocardial infarction.

The greater mortality observed in women compared to men after acute myocardial infarction remains unexplained. Using an analysis of pairs, matched on a conditional probability of being male (propensity score), we assessed the effect of the baseline characteristics and management on 30-day mortality. Consecutive patients were included from January 2006 to December 2007. Two propensity scores (for being male) were calculated, 1 from the baseline characteristics and 1 from both the baseline characteristics and treatment. Two matched cohorts were composed using 1:1 matching and computed using the best 8 digits of the propensity score. Paired analyses were performed using conditional regression analysis. During the study period, 3,510 patients were included in the registry; 1,119 (32%) were women. Compared to the men, the women were 10 years older, had more co-morbidities, less often underwent angiography and reperfusion, and received less medical treatment. The 30-day mortality rate was 12.3% (130 of 1,060) for the women and 7.2% (167 of 2,324) for the men (p <0.001). The 2 matched populations represented 1,298 and 1,168 patients. After matching using the baseline characteristics, the only difference in treatment was a lower rate of angiography and reperfusion, with a trend toward greater 30-day mortality in women. After matching using both baseline characteristics and treatment, the 30-day mortality was similar for the men and women, suggesting that the increased use of invasive procedures in women could potentially be beneficial. In conclusion, compared to men, the 30-day mortality is greater in women and explained primarily by differences in baseline characteristics and to a lesser degree by differences in management. The difference in the use of invasive procedures persisted after matching by characteristics. In contrast, after matching using the baseline characteristics and treatment, the 30-day mortality was comparable across the genders.

Long-term prognostic value of residual pulmonary vascular obstruction at discharge in patients with intermediate- to high-risk pulmonary embolism

BACKGROUND We evaluated prognostic value at 6 months of residual pulmonary vascular obstruction (RPVO) measured before discharge in patients with intermediate- or high-risk pulmonary embolism (PE). METHODS AND RESULTS Prospective registry including 416 consecutive patients with intermediate- or high-risk PE who survived the acute phase. Patients with previous cardiopulmonary disease were excluded. Perfusion lung scans were performed within 6-8 days after the onset of treatment. Residual pulmonary vascular obstruction was graded as the proportion of the lung not perfused. Primary objective was a combined endpoint at 6 months, including death, recurrent PE, and appearance of signs of heart failure. At 6 months, 32 patients (7.7%) had at least one adverse event: 12 deaths (2.9%), 12 recurrent PE (2.9%), and 14 (3.4%) heart failure. Independent predictors of combined endpoint were: cancer [odds ratio (OR) 3.07 (1.22-7.85)]; renal insufficiency at admission [OR: 2.53 (1.17-5.8)]; persistent signs of right ventricular dysfunction at 48 h echography [OR: 3.99 (1.36-11.3)]. The severity of RPVO at discharge was significantly associated with an unfavourable outcome [OR: 2.66 (1.58-3.93)]. The incremental prognostic value of RPVO information was confirmed by significantly improved goodness-of-fit. Threshold RPVO for predicting adverse events was estimated at 35% [area under the curve = 0.76 (0.73-0.82)]. Patients with RPVO greater than threshold at discharge had a significantly higher risk of death at 6 months (P = 0.01). CONCLUSIONS Residual pulmonary vascular obstruction evaluated before hospital discharge in patients with intermediate- to high-risk PE is a powerful prognostic factor for a 6-month outcome. RPVO ≥35% is associated with an increased risk of adverse events at 6 months.

Prognostic value of albuminuria on 1-month mortality in acute myocardial infarction.

RATIONALE An increase in albuminuria occurs in the early days after acute myocardial infarction. The aim of this study was to assess the relation between albuminuria and 30-day mortality, as well as its incremental predictive value, on top of established prognostic parameters. METHODS AND RESULTS Demographic, clinical, and biological characteristics at admission, as well as in-hospital treatments and 1-month survival, were recorded in 1,211 consecutive patients admitted for acute myocardial infarction. Albuminuria was assessed from an 8-hour overnight urine collection within the first 2 days using immunonephelemetry. The population was categorized into 3 groups according to albuminuria levels (<20, 20-200, and >200 microg/min). Among survivors on day 2, 52% (625/1,211) of patients had an albuminuria level <20 microg/min, 39% (477) between 20 and 200 microg/min, and 9% (109) >200 microg/min. High levels of albuminuria were associated with older age, peripheral vessel disease, systolic blood pressure, glucose, creatinine, troponin, B-type natriuretic peptide, and high-sensitivity C reactive protein levels, as well as use of angiography, angiotensin-converting enzyme inhibitors, and beta blockers. At 1 month, there was a significantly higher mortality rate in groups with higher albuminuria. After adjustment for baseline characteristics, patients with albuminuria level of >20 microg/min had a 2.7-fold higher 30-day mortality, and those with >200 microg/min had an almost 4-fold higher 30-day mortality compared to those with albuminuria level of <20 microg/min. The addition of albuminuria information improved the discrimination capacity of the model and the global risk prediction. CONCLUSIONS Albuminuria level, taken as a quantitative or categorical variable, is an independent and powerful predictor of mortality after acute myocardial infarction.

Does optical coherence tomography optimize results of stenting? Rationale and study design

BACKGROUND To date, no randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes. METHODS DOCTORS is a randomized, prospective, multicenter, open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes. Patients (n = 250) will be randomized to undergo OCT-guided angioplasty (use of OCT to optimize procedural result, including change to strategy with the possibility of additional interventions) or angioplasty under fluoroscopy alone. The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) measured at the end of the procedure. Secondary end points include safety of OCT in the context of angioplasty for ACS, percentage of patients in whom OCT reveals suboptimal result of stenting, percentage of patients in whom a change in procedural strategy is decided based on OCT data, correlation between quantitative measures by OCT and FFR, determination of a threshold for quantitative OCT measure that best predicts FFR ≥ 0.90, and identification of OCT variables that predict postprocedure FFR. Adverse cardiac events (death, recurrent myocardial infarction, stent thrombosis, and repeat target lesion revascularization) at 6 months will be recorded. CONCLUSION The DOCTORS randomized trial (ClinicalTrials.gov NCT01743274) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and, if so, whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR.