Implantation depth measured by 64-slice computed tomography is associated with permanent pacemaker requirement following transcatheter aortic valve implantation with the Core Valve(®) system.

BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk for post-interventional conduction disturbances leading to pacemaker (PM) implantation. We analyzed the association between implantation depth within the left ventricular outflow tract (LVOT), measured by 64-slice computed tomography (CT), and 'index electrocardiographic (ECG) changes' (new onset atrioventricular-block grade II or III or left bundle branch block with PR interval prolongation >200ms). METHODS: We evaluated patients who underwent TAVI with the Core Valve(®) revalving system (Medtronic, Minneapolis, MN, USA) for treatment of severe aortic stenosis at our department. Patients with a prior PM implantation and patients for whom no CT scan was available after 3 months were excluded from analysis. We assessed implantation depth of the prosthesis within the LVOT as possible risk factors for the development of post-interventional 'index ECG changes' resulting in PM implantation and compared it with individual patient data as well as echocardiographic and electrocardiographic parameters. RESULTS: The final study cohort comprised 53 patients for whom a 64-slice CT scan was available (mean age 81.7±5.1 years, 36% male). Twenty-eight of these finally underwent PM implantation due to 'index ECG changes' within the first 48hours after TAVI. Univariate logistic regression analysis could identify implantation depth of the prosthesis as the only significantly correlated risk factor for PM need in our cohort (OR 1.27, 95% CI: 1.08-1.51, p=0.004). A cut-off value of 6mm predicted this need with a sensitivity of 89% and specificity of 40%. CONCLUSION: Implantation depth of the Core Valve(®) into the LVOT was associated with post-procedural PM requirement. Thereby, a cut-off value of 6mm, as measured by 64-slice CT, proved useful to define patients at risk for PM requirement.

Individual-patient visit-by-visit office and ambulatory blood pressure measurements over 24months in patients undergoing renal denervation for hypertension.

BACKGROUND: Renal denervation (RDN) is a promising treatment option in addition to medical antihypertensive treatment in patients suffering from resistant hypertension. Despite the growing interest in RDN, only few long-term results are published so far. METHODS: We systematically investigated the effects of RDN on ABPM in a consecutive series of patients with resistant hypertension out to 24 months. Office BP measurements and ABPM assessment were offered at 3, 6, 12 and 24 months. The patients with an average systolic BP reduction of more than 10 mmHg in office BP 6months after RDN were classified as responders. Additional to this classical responder concept, we categorized response to RDN by an individual-patient visit-by-visit evaluation of office BP and 24-hour-BP, separately. RESULTS: We included 32 patients. In 21 patients (65.6%) we found a mean systolic BP reduction >10 mmHg in office BP six months after RDN. These patients were classified as responders. In responders, mean office BP dropped from 175.3 ± 15.9/96 ± 14.2 mmHg to 164.8 ± 24.4/93.2 ± 10.4 mmHg (p=0.040/p=0.323) and mean 24-h BP in ABPM decreased from 146.8 ± 17.0/89.1 ± 11 mmHg to 136.8 ± 15.0/83.2 ± 10.7 mmHg after 24 months (p=0.034/p=0.014). Additionally, we performed a visit-by-visit evaluation of all patients and results were divided in larger-than-median and smaller-than-median response. By this evaluation, we found a high variation of office BP reductions and the 24-hour BP results demonstrated a significant BP reduction in patients with larger-than-median response, which sustained over the 24 months of follow-up. CONCLUSIONS: In contrast to the observed variation of office BP measurements, ABPM demonstrated a reproducible and sustained significant BP reduction in patients with larger-than-median response to RDN.

Effects of renal denervation on ambulatory blood pressure measurements in patients with resistant arterial hypertension.

BACKGROUND: The sympathetic nervous system is an important factor in hypertension. In patients suffering from resistant hypertension, transfemoral renal sympathetic denervation (RDN) reduces office blood pressure (BP) values. HYPOTHESIS: Ambulatory BP measurement (ABPM) is a better predictor than office BP of cardiovascular morbidity and mortality. We thus believe that ABPM should be added to the systematic evaluation and follow-up protocol when treating patients with resistant hypertension with RDN. Therefore, we evaluated the effect of RDN on mean 24-hour BP by the use of ABPM. METHODS: Patients with resistant hypertension (office systolic BP >160 mm Hg, or >150 mm Hg in patients with diabetes) have been treated with RDN. Ambulatory BP measurement was performed at baseline and at 3 and 6 months after RDN. Patients with a 24-hour systolic BP reduction of ≥5 mm Hg were classified as responders. RESULTS: Of 86 patients initially enrolled in the study, 5 had to be excluded from the analysis because of <70% valid ABPM recordings. Out of the 81 studied patients, we found 49 responders (60.5%). In all patients, office BP decreased from 169.9/87.8 mm Hg to 153.5/86.3 mm Hg (P < 0.001/P = not significant [NS]) and 24-hour BP decreased from 144.3/86.0 mm Hg to 139.9/84.0 mm Hg (P = 0.025/P = NS) 6 months after RDN. In responders, office BP decreased from 169.6/90.3 mm Hg to 143.7/79.7 mm Hg (P < 0.001/P < 0.001). The ABPM levels started at 144.3/84.7 mm Hg and decreased to 138.3/81.5 mm Hg (P = 0.025/P = 0.045). In nonresponders, office BP was 150.2/84.0 mm Hg and 24-hour BP was 144.5/84.7 mm Hg at baseline; at 6 months, office BP was 168.7/96.4 mm Hg (P < 0.001/P = NS) and 24-hour BP was 142.2/81.5 mm Hg (P = NS/P = NS). CONCLUSIONS: Office BP and AMBP levels can be significantly lowered by RDN in patients with resistant hypertension.

A validated risk score to predict outcomes after carotid stenting.

BACKGROUND: Periprocedural outcome has been extensively investigated in patients undergoing carotid artery stenting. However, risk factors contributing to long-term mortality have not been comprehensively assessed. We aimed to establish a validated clinical risk score for long-term mortality in patients after carotid artery stenting. METHODS AND RESULTS: Two independent cohorts after successful carotid artery stenting (602 and 552 patients) were prospectively investigated. Multivariable Cox regression and bootstrap variable selection were used to select the best-fitting multivariable model. The mortality rate was 35% in the derivation and 39% in the validation cohort during a median follow-up of 6.5 and 7.4 years, respectively. The following variables were identified as most robust risk factors in the derivation cohort: age, heart failure, diabetes mellitus, relative lymphocyte count, prothrombin time, peripheral artery disease, and contralateral carotid occlusion. A weighted multimarker risk score yielded an area under the receiver operating characteristic curve of 0.79 in the derivation (P<0.001) and of 0.69 (P<0.001) in the validation cohort. In comparison, the best area under the receiver operating characteristic curves for single risk factors were 0.67 and 0.63, respectively. For optimal clinical use, a simplified risk score was also developed, which discriminated very well from very low to very high risk. The risk of all-cause mortality ranged from 8% for a score of 1 to 93% for a score of 7 (P<0.001) in the derivation and from 11% to 100% in the validation cohort (P<0.001). CONCLUSIONS: A multimarker risk score outperformed the prognostic value of single risk factors for the prediction of long-term mortality.

Incidence of stent thrombosis in patients with drug eluting stents and short-term dual antiplatelet therapy.

AIMS: This study sought to investigate the incidence of stent thrombosis (ST) in patients treated with drug-eluting stents (DES) and clearly defined short-term dual antiplatelet therapy (DAT) for three or six months for sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES), respectively. METHODS AND RESULTS: A series of 1023 consecutive patients with 1,414 stented lesions and prescribed short-term DAT were followed for at least two years after DES implantation. The individual durations of DAT, the rate of ischaemic events, and survival status were assessed. Follow-up was completed for 1017 patients (99.4%) with a mean follow-up of 3.0 +/- 0.7 years. DAT duration was 2.8 +/- 0.4 and 5.9 +/- 0.8 months in patients with SES and PES, respectively. Adherence to continued single antiplatelet therapy was 98.4%. We identified 14 patients with definite ST (1.4%) and no patients with probable ST with a cumulative incidence of 0.6% at 30 days, of 0.8% at one year, of 1.2% at 2 years, and of 1.4% at three years. CONCLUSIONS: Definite or probable ST after DES implantation and short DAT occurs with a cumulative incidence of 1.4% at 3 years if excellent patient adherence to the continued single antiplatelet therapy can be achieved.

TIMI 3 flow after primary angioplasty is an important predictor for outcome in patients with acute myocardial infarction.

BACKGROUND: Growing evidence suggests that poor coronary blood flow after primary percutaneous coronary intervention (PCI) is associated with unfavorable clinical out-come. We retrospectively evaluated data from our single center "real world patients" database of patients undergoing primary PCI to determine differences in clinical and angiographic patterns in patients with or without restoring thrombolysis in myocardial infarction (TIMI) flow 3. METHODS AND RESULTS: Between 2001 and 2006, 500 patients underwent primary PCI for STEMI. In 430 patients, post-interventional TIMI flow 3 could be established. In this group, in-hospital mortality was significant lower (6.4% Vs. 32.9%; P < 0.0001), left ventricular ejection fraction was better (51.3 Vs. 44.2%; P < 0.0001), and prehospital fibrinolytic therapy (6.3% Vs. 14.3%; P = 0.015), cardiogenic shock (10.9% Vs. 24.3%; P = 0.002) and use of intra-aortic balloon pump were all more unlikely (5.8% Vs. 11.4%; P = 0.045) compared to patients with TIMI flow < or = 2. In patients with post-interventional TIMI flow < or = 2 the left anterior descending coronary artery (LAD) was significantly more often seen as the target vessel (54.3% Vs. 44.6%; P = 0.039). A regressions analysis showed that predictors leading to such flow patterns are diabetes (P = 0.013), pre-hospital fibrinolytic therapy (P = 0.017), cardiogenic shock (P = 0.002) and a 3-vessel disease (P = 0.003). After 6 months, patients without restored normal TIMI flow had worse New York Heart Association functional class (NYHA), and had to undergo repeat coronary angiography more often. CONCLUSION: Post-interventional TIMI flow < or = 2 is strongly associated with adverse out-come during hospitalization and after 6 months following hospitalization.

In-stent restenosis in bare metal stents versus sirolimus-eluting stents after primary coronary intervention for acute myocardial infarction and subsequent transcoronary transplantation of autologous stem cells.

BACKGROUND: Following stenting for acute myocardial infarction, transcoronary transplantation of granulocyte-colony stimulating factor (G-CSF) mobilized autologous stem cells (ASC) has been shown to result in an increased in-stent restenosis rate of bare metal stents (BMS). HYPOTHESIS: This study sought to compare the extent of neointimal growth in BMS and sirolimus-eluting stents (SES) after primary implantation, and subsequent transcoronary transplantation of G-CSF mobilized stem cells. METHODS: Patients with stenting of the left anterior descending coronary artery for acute anterior myocardial infarction were randomly assigned to receive a BMS or SES. Intracoronary stem cell injection was performed after G-CSF application for at least 4 d and cell apheresis. The angiograms obtained after cell transplantation and after 6 mo were analyzed by quantitative coronary angiography. RESULTS: We performed primary stenting and stem cell transplantion in 16 patients who received a BMS (n = 8) or an SES (n = 8). In 2 patients with a BMS, late stent thrombosis occurred after 58 d and 177 d, respectively. In the remaining patients, control angiography after 6 mo revealed in-stent restenosis of >50% in no patients with SES but in 4 patients with BMS (67%). Late lumen loss and in-stent plaque volume were significantly higher in patients with BMS compared with patients with SES. CONCLUSIONS: Compared with BMS, SES impair in-stent intima hyperplasia after stenting for acute myocardial infarction and transcoronary transplantation of G-CSF mobilized ASC.

Risk score for peri-interventional complications of carotid artery stenting.

BACKGROUND AND PURPOSE: Routinely available independent risk factors for the peri-interventional outcome of patients undergoing elective carotid artery stenting (CAS) are lacking. The rationale of the study was to create a risk score identifying high-risk patients. METHODS: We prospectively enrolled 606 consecutive patients assigned to CAS at a secondary care hospital. Various biochemical, clinical, and lesion-related risk factors were prospectively defined. The primary end point reflecting periprocedural complications encompassed minor and major stroke, nonfatal myocardial infarction and all-cause mortality within 30 days. RESULTS: Three percent of patients (n=18) experienced a nonfatal minor (n=13) or major (n=5) stroke. 1.3% of patients (n=8) died from fatal stroke (n=4) or other causes (n=4). No myocardial infarction was observed within 30 days after stenting. Multivariable analysis revealed diabetes mellitus with inadequate glycemic control (HbA1c > 7%), age > or = 80 years, ulceration of the carotid artery stenosis, and a contralateral stenosis > or = 50% as independent risk factors. A risk score formed with these variables showed a superior predictive value (C-statistic = 0.73) compared with single risk factors. The presence of 2 or more of these risk factors identified patients with a risk of 11% for a periprocedural complication compared with 2% in patients with a score of 0 or 1. CONCLUSIONS: In patients undergoing elective CAS, a risk score based on routinely accessible variables was able to identify patients at high-risk for atherothrombotic events and all-cause death within 30 days after the intervention.

Long-term follow-up in patients with lost coronary stents during interventional procedures.

The aim of this retrospective study was to determine the incidence of stent loss during interventional procedures and to identify the associated immediate and long-term consequences of such loss. We evaluated 36 cases in which the stents were prematurely displaced from the stent delivery device. Five stents were completely removed from the vascular system successfully. Five stents could not be retrieved from the coronary circulation and led to significant adverse events in 3 patients, in whom the lost stents were not excluded by the placement of another stent. In 26 patients, peripheral embolism below the renal arteries occurred after successful stent retrieval from the coronary arteries. Of these 26 patients, 1 patient died during hospital stay, unrelated to the peripheral stent loss. Additional follow-up examinations were performed for 20 of the remaining 25 patients. Clinical patient status and the ankle-brachial index were evaluated 59 +/- 30 months after stent loss. All patients were free of any stent-related peripheral ischemic symptoms. We also attempted to determine the exact physical locations of the lost stents using computed tomography during follow-up. In 15 patients, we were able to detect the stent in the peripheral arteries using computed tomography. In conclusion, if stents cannot be retrieved from the coronary system, severe problems may occur. Stent loss with peripheral embolization is asymptomatic in long-term follow-up.

Mid-term outcome after carotid artery stenting depends on presence of coronary artery disease.

BACKGROUND: Longer-term outcome of patients following carotid artery revascularization depends predominantly on cardiac events rather than neurological events. AIM: To assess the longer-term outcomes of patients with known coronary artery morphology undergoing carotid artery stenting. METHOD: In a prospective observational study including 549 consecutive patients undergoing carotid artery stenting, a coronary angiography was performed in a single session unless a recent angiogram was available. Following the intervention, patients were followed prospectively to determine neurological events as well as major adverse coronary events (MACE) during long-term follow-up. RESULTS: Coronary artery disease was present in 378 patients including 92 patients without current significant stenosis. The MACE rate was 6.4% in patients without coronary artery disease compared to 28.3% in patients with coronary artery disease (P<0.00001). Cardiac and all-cause mortality were statistically significantly higher in patients with a significant coronary stenosis than in patients without coronary artery disease (P<0.001 and P<0.01). Cardiac mortality and all-cause mortality were 2.3% and 7.6% in patients without coronary artery disease (patient group I), 7.6% and 13.0% in patients with coronary artery disease but no current significant stenosis (patient group II), and 10.5% and 16.1% in patients with significant coronary stenosis (patient group III). Neurological events, however, were distributed equally among the three patient groups. CONCLUSIONS: In the longer term, outcomes in patients undergoing carotid artery stenting depend on concomitant coronary artery disease rather than neurological events, cardiac mortality and even all-cause mortality depending on a significant coronary artery stenosis.

Thrombus aspiration prior to primary angioplasty in acute myocardial infarction: estimation of rescued myocardial tissue by return of ST-segment elevation.

BACKGROUND: The goal of the study was to validate the clinical benefit of adjunctive thrombus aspiration prior to balloon or stent angioplasty in patients with acute myocardial infarction. HYPOTHESIS: Adjunctive thrombus aspiration reduces no-reflow by eliminating peripheral thromboembolism. METHODS: In all, 143 consecutive patients underwent primary angioplasty for acute myocardial infarction in our institution. We excluded patients with subacute stent thrombosis or bundle-branch pattern of the electrocardiogram (ECG) and divided the remaining 131 into two groups: 62 patients who underwent intervention without a thrombus aspiration device (Group 1) and 69 patients who were treated as soon as a specifically designed thrombus aspiration catheter became available at our institution (Group 2). The intention was to use thrombus aspiration in every suitable case with proximal occlusion of a major vessel. The reduction of the sum of ST-segment elevation following angioplasty as a marker of rescued myocardial tissue was compared between the two groups. RESULTS: Thrombus aspiration was technically feasible in 23 of 25 attempted cases. The reduction of the sum of ST-segment elevation following intervention was 0.41 +/- 0.39 mV in Group 1 and 0.37 +/- 0.42 mV in Group 2 (p > 0.05). CONCLUSIONS: Thrombus aspiration may be helpful during primary angioplasty in selected cases but does not improve the general outcome. Other reasons for "no-reflow," apart from peripheral thromboembolism, seem to be responsible for the lack of clinical benefit.

Simultaneous stenting of the carotid artery and other coronary or extracoronary arteries: does a combined procedure increase the risk of interventional therapy?

Simultaneous interventions in carotid and other extracarotid arteries are not performed on a routine basis up to now. In 67 out of 295 consecutive patients (23%) undergoing elective stenting of the internal carotid artery, additional interventions in the coronary arteries (n = 65), the iliac artery (n = 3), renal artery (n = 1), left subclavian artery (n = 3), vertebral artery (n = 4), or a combination thereof were performed. Primary stenting was done in 51 (74%) out of 69 carotid arteries, in 48 (74%) of 65 coronary arteries, and in 10 (91%) of 11 other targeted vessels. Neurological complications consisted of two (2.9%) transient ischemic attacks and one (1.5%) minor stroke. In addition, one (1.5%) myocardial infarction occurred during coronary artery intervention. In comparison, 16 (6.6%) transient ischemic attacks, 1 minor stroke (0.4%), 5 (2.2%) major strokes, and 3 (1.2%) deaths were observed in 228 patients without combined procedures. Simultaneous percutaneous interventions including carotid arteries and other extracarotid arteries are feasible, relatively safe, and cost-effective.

Carotid sinus reactions during carotid artery stenting: predictors, incidence, and influence on clinical outcome.

Carotid sinus reactions (CSR), defined as asystole >/= 3 sec and hypotension (systolic blood pressure ostial > isolated internal carotid artery; P < 0.001). The other independent predictors were presence of contralateral stenosis (P < 0.02), length of stenosis (P < 0.03), and balloon-to-artery ratio (P < 0.02). Occurrence of CSR was unrelated to periprocedural cerebral or cardiovascular complications (7.1% vs. 9.5%; NS). We conclude that CSR occurs frequently (40%) during CAS. Bifurcation location of stenosis is the most important predictor of CSR. CSR does not increase the risk of periprocedural complications.

Abciximab bolus injection does not reduce cerebral ischemic complications of elective carotid artery stenting: a randomized study.

BACKGROUND AND PURPOSE: Abciximab has been shown to significantly reduce thromboembolic complications of coronary artery stenting. A prospective, randomized study was performed to test whether abciximab has comparable beneficial effects in carotid artery stenting. METHODS: Seventy-four consecutive patients undergoing elective stenting of the carotid artery were included in the study. Standard antithrombotic medication consisted of aspirin, clopidogrel, and heparin. In addition, half of the patients received an abciximab bolus of 0.25 mg/kg body weight given prophylactically before the intervention. RESULTS: The procedure was successful in all but 1 patient. In patients receiving abciximab, ischemic complications consisted of 4 transient ischemic attacks, 1 minor stroke, 1 nonfatal major stroke, and 1 fatal stroke caused by cerebral hemorrhage. In the control group, 2 transient ischemic attacks and 1 major nonfatal stroke occurred. In summary, the total number of periprocedural ischemic events was 7 (19%) in the abciximab group and 3 (8%) in the control group. Nonischemic complications consisted of 1 inguinal hematoma requiring blood transfusions in each group. CONCLUSIONS: Abciximab bolus given prophylactically before elective carotid artery stenting does not reduce ischemic complications.