Gert Richardt

Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis.

OBJECTIVESnThe purpose of this study was to determine the predictors of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI).nnnBACKGROUNDnTAVI has been associated with a high rate of paravalvular regurgitation, usually mild. Nevertheless, moderate to severe regurgitations still occur and may have negative clinical consequences.nnnMETHODSnFifty patients with severe aortic stenosis were recruited and underwent successful TAVI with the Medtronic CoreValve bioprosthesis through the transfemoral route. The end point of this study is the early occurrence of significant AR, defined as the occurrence of grade II or more AR by post-procedural aortography.nnnRESULTSnThe study populations mean age was 80.5 ± 7.9 years, with a mean aortic valve area of 0.64 ± 0.17 cm². Post-procedural AR was absent in 3 patients and was grade I in 27 patients, grade II in 13 patients, and grade III in 7 patients. Using univariate analysis, the chance of significant AR increased with increasing angle of left ventricular outflow tract to ascending aorta (∠LVOT-AO) (odds ratio: 1.24, p < 0.001). For the depth of the device in relation to the noncoronary cusp, there was a minimum chance of AR corresponding to depth = 9.5 mm (odds ratio: 1.1, p = 0.01). Using multivariate analysis, we found a greater chance of significant AR with a greater angle (odds ratio: 1.24, p = 0.001), and that the chance of significant AR is a minimum when depth of the device in relation to the noncoronary cusp is ∼10 mm (odds ratio: 1.1, p = 0.024). A predictive model was generated, and if 2 ×∠LVOT-AO + (depth to noncoronary cusp - 10)² ≥ 50, the likelihood of occurrence of significant AR could be predicted with a sensitivity of 85% and a specificity of 87%.nnnCONCLUSIONSnThe occurrence of significant AR after TAVI can be predicted by anatomic and procedural variables. A model such as that presented can be used to select suitable patients for this procedure and guide operators during implantation of the device.

Comparison of Hospital Mortality With Intra-Aortic Balloon Counterpulsation Insertion Before Versus After Primary Percutaneous Coronary Intervention for Cardiogenic Shock Complicating Acute Myocardial Infarction

Primary percutaneous coronary intervention (PCI) and intra-aortic balloon pump counterpulsation (IABP) are established treatment modalities in acute myocardial infarction complicated by cardiogenic shock. We hypothesized that the insertion of the IABP before primary PCI might result in better survival of patients with cardiogenic shock compared to postponing the insertion to after primary PCI. We, therefore, retrospectively studied 48 patients who had undergone primary PCI with IABP because of cardiogenic shock complicating acute myocardial infarction (26 patients received the IABP before and 22 patients after primary PCI). No significant differences were present in the baseline clinical characteristics between the 2 groups. The mean number of diseased vessels was greater in the group of patients treated with the IABP before primary PCI (2.8 +/- 0.5 vs 2.3 +/- 0.7, p = 0.012), but the difference in the number of treated vessels was not significant. The peak creatine kinase and creatine kinase -MB levels were lower in patients treated with the IABP before primary PCI (median 1,077, interquartile range 438 to 2067 vs median 3,299, interquartile range 695 to 6,834, p = 0.047, and median 95, interquartile range 34 to 196 vs median 192, interquartile range 82 to 467, p = 0.048, respectively). In-hospital mortality and the overall incidence of major adverse cardiac and cerebrovascular events were significantly lower in the group of patients receiving the IABP before primary PCI (19% vs 59% and 23% vs 77%, p = 0.007 and p = 0.0004, respectively). Multivariate analysis identified renal failure (odds ratio 15.2, 95% confidence interval 3.13 to 73.66) and insertion of the IABP after PCI (odds ratio 5.2, 95% confidence interval 1.09 to 24.76) as the only independent predictors of in-hospital mortality. In conclusion, the results of the present study suggest that patients with cardiogenic shock complicating acute myocardial infarction who undergo primary PCI assisted by IABP have a more favorable in-hospital outcome and lower in-hospital mortality than patients who receive IABP after PCI.

Comparison of carvedilol and metoprolol in patients with acute myocardial infarction undergoing primary coronary intervention--the PASSAT Study.

SummaryBackgroundThe value of early therapy with beta-blocking agents in acute myocardial infarction (AMI) undergoing reperfusion is not yet well established. Newer beta-blocking agents such as carvedilol offer potential advantages in the setting of ischemia and reperfusion injury.MethodsWe randomized 100 patients with acute ST-elevation myocardial infarction (STEMI) to receive either 12.5 mg carvedilol or 50 mg metoprolol tartrate orally already before percutaneous coronary intervention (PCI) of the infarct-related artery, uptitrating to a daily target dose of 50 mg carvedilol or 150 mg metoprolol during the first week. Pts. were subjected to left ventricular (LV) angiography just before reperfusion and after 14 days to compare ejection fraction (EF) and regional wall motion abnormalities by quantitative LV analysis. Furthermore, kinetics of cardiac troponin T (cTnT), NT-proANP, NT-proBNP, endothelin, argenine vasopressin, epinephrine and norepinephrine were assessed during the first 12 hours and again at 2 weeks. In addition, reperfusion-induced rhythm abnormalities like VT, triplets, couplets, and bradycardic events were assessed continuously during the first 12 hours starting at reperfusion by Holter analysis.ResultsBoth groups did not differ with respect to onset of pain, target vessel, extent of coronary heart disease, age, gender, rate of stenting or use of a GP IIb/IIIa inhibitor, pre- and postinterventional TIMI flow grade, time course of heart rate or blood pressure. There were neither significant differences in the cardiac and neurohumoral markers nor in the occurrence of arrhythmias between both treatment groups. Within 14 days, EF improved by 5.8±2.0% (mean±SEM) in the metoprolol group and by 5.2±2.1% in the carvedilol group (n.s.). Area of infarction was reduced by 6.1±2.9% in the metoprolol group and by 12.8±3.6% of total LV outline in the carvedilol group (n.s.). Maximum hypokinesia in the central infarcted region was diminished by 0.40±0.11 standard deviation (SD) in the metoprolol group and by 0.34±0.13 SD in the carvedilol group (n.s.).ConclusionIn the setting of direct PCI in acute STEMI, administration of carvedilol before reperfusion appears not to be superior to metoprolol with respect to myocardial injury and improvement of global and regional LV function. The study documents equivalent improvement of LV function and similar kinetics of cardiac and neurohumoral markers in pts. with acute STEMI undergoing direct PCI if the pts. were immediately treated with either carvedilol or metoprolol. Thus, superiority of carvedilol in experimental studies did not translate into a clinical benefit.

Altered calcium transient and development of hypertrophy inβ2-adrenoceptor overexpressing mice with and without pressure overload

Transgenic (TG) mice with cardiac specific 200‐fold overexpression of β2‐adrenoceptors (β2‐AR) have a facilitated development of heart failure following thoracic aortic constriction (TAC). We have studied the alterations of intracellular Ca2+ transients and myocyte size in wild‐type (WT) and TG mice after TAC. Cardiomyocytes were isolated from mice 9 weeks after TAC or sham operation, and incubated with Fura 2/AM. The Ca2+ transients were determined by Spex dual wavelength Spectrometer during electrical stimulation. The cell size was also determined planimetrically. Cells of sham operated TG mice displayed higher systolic Ca2+ amplitude than respective WT group (ΔF340/F380 ratio: 1.05±0.08 vs. 0.63±0.05; P<0.01), a finding in keeping with enhanced ventricular contractility in the TG mice. However, hypertrophied and failing myocytes of TG animals showed a fall in Ca2+ transients from sham‐operated control levels and there was no difference between TG and WT groups following TAC. In sham‐operated groups, the cell size of TG mice was significantly bigger than in WT animals (3212±139 vs. 2605±162 μm2; P<0.05). The cell size increased to a similar extent in both groups after TAC (4715±216 vs. 5027±365 μm2, P=n.s.). In summary, hypertrophy of cardiomyocytes was present in β2‐AR TG mice under baseline conditions. A further hypertrophy occurred during pressure overload to an extent similar to that in WT animals. However, the increased intracellular Ca2+ transient, seen in sham‐operated TG mice, was no longer detectable following development of severe hypertrophy and heart failure. These findings provide explanation on the lack of hemodynamic benefit in β2‐AR TG mice subjected to pressure overload.

A case of rotational atherectomy after implantation of the Medtronic CoreValve bioprosthesis

Sirs: Despite the paucity of data regarding the outcome of percutaneous coronary intervention (PCI) before performing transcatheter aortic valve implantation, (TAVI) [1–3], PCI prior to TAVI whether as a staged or a combined transfemoral procedure remains an accepted wisdom. However, a strategy of pre-TAVI PCI is not universally possible. Coronary artery disease (CAD) is a progressive disease and so PCI after TAVI becomes sometimes necessary. We report the first case of rotational atherectomy in the setting of multivessel PCI after implantation of the Medtronic CoreValve prosthesis (MCP). An 86-year-old active male patient presented with progressive dyspnea (NYHA III on admission). Diagnostic work-up revealed severe calcific aortic stenosis and invasive coronary angiography revealed 60 % calcific left anterior descending artery (LAD) stenosis, 80 % left circumflex artery (LCX) stenosis, and 50 % distal right coronary artery (RCA) lesion. Successful TAVI using a 29-mm MCP (Medtronic Parkway, Minneapolis, MN, USA) preceded by LCX stenting were performed. The TAVI was performed under local anesthesia with mild sedation [4]. He presented 14 months later with progressive dyspnea. Echocardiography revealed a well-functioning MCP (mild paravalvular aortic regurgitation, mean/ peak pressure gradient 5/20 mmHg), and so conservative management was advised. As the patient did not improve despite optimum medical treatment, stress echocardiography was then performed revealing jeopardized ischemic myocardium in the three LAD, LCX and RCA supplied territories. Coronary angiography revealed progression of his CAD with now a significant (80 %) calcific proximal LAD stenosis, a 70 % mid LAD lesion (Fig. 1a), an 80 % diffuse in-stent restenosis in the LCX, and an 80 % distal RCA lesion. There was a minimal gradient across the aortic valve with mild AR. Our heart team’s decision was to perform multivessel staged PCI because of moderate renal failure (GFR = 48 ml/min). PCI to RCA was then performed after a relatively easy intubation with a 6 French JR4 Launcher guiding catheter (Medtronic, Minneapolis, MN, USA) using a Xience Prime 3.0 9 8 mm stent (Abbott Vascular, Illinois, USA). 4 weeks later, PCI to LAD and LCX was performed. The case was part of a live presentation at the annual meeting of the German Cardiac Society in April 2011. Cannulating the left main artery with a 7F JL4 Launcher guiding catheter was cautiously performed. A BMW wire (Abbott Vascular, Illinois, USA) was then advanced across the LCX lesion, followed by successful dilatation of the restenotic segment with a Pantera Lux paclitaxel-releasing balloon (Biotronik, Berlin, Germany) with satisfactory immediate angiographic results. A second BMW wire was placed in the LAD. Pre-dilatation of the mid LAD followed by stenting with a 2.5 9 23 mm Xience Prime stent was then performed. The proximal heavily calcified LAD lesion could not be adequately dilated even with a 2.5 9 8 mm noncompliant Quantum Apex balloon (Boston Scientific Corporation, Boston, MA, USA) despite high-pressure inflation (Fig. 1b). Due to our high experience and familiarity with rotational atherectomy, a strategy of rotablating calcified lesions that do not respond well to balloon dilatation with non-compliant balloons is usually attempted. So rotablation was performed using a 1.5-mm burr (Rota Link plus, Boston Scientific Corporation, Boston, MA, USA) M. Abdel-Wahab A. E. Mostafa (&) G. Richardt Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the University of Kiel), Am Kurpark 1, 23795 Bad Segeberg, Germany e-mail: ahmad_sayedyousef@yahoo.com

Long-Term Clinical Outcome of Thin-Strut Cobalt-Chromium Stents in the Drug-Eluting Stent Era: Results of the COBALT (Comparison of Bare-Metal Stents in All-Comers’ Lesion Treatment) Registry

BACKGROUNDnDespite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking.nnnMETHODS AND RESULTSnThis single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16).nnnCONCLUSIONnIn the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.

Risk factors for clinical events at 1-year follow-up after drug-eluting stent implantation: results from the prospective multicenter German DES.DE registry.

BackgroundDrug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option.Methods and resultsIn the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6xa0%, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1xa0year.ConclusionData collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

Outcome of percutaneous coronary intervention with drug-eluting stents in unprotected left main versus non-left main native coronary artery disease: results from the prospective multicenter German DES.DE registry

BackgroundUnprotected left main coronary artery (ULMCA) disease is considered an indication for surgical revascularization. However, refined percutaneous coronary intervention (PCI) technology and modern drug-eluting stents (DES) render the ULMCA a target for interventional treatment.Methods and resultsBetween October 2005 and September 2009, 374 patients receiving DES in ULMCA and 18,678 patients receiving DES in non-left main coronary arteries (nLMCA) with no previous coronary artery bypass graft surgery, were registered at 130 DES.DE sites. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) were defined as primary endpoints. Baseline clinical and descriptive morphology of coronary artery disease revealed more comorbidities and more complex anatomies in the ULMCA group. At 1-year follow-up, the ULMCA group suffered from higher rates of overall death (5.6 versus 2.3xa0%; pxa0<xa00.0001), stroke (2.0 versus 0.8xa0%; pxa0<xa00.05), MACCE (8.6 versus 4.9xa0%; pxa0<xa00.01); whereas rates for definite/probable stent thrombosis (2.4 versus 1.6xa0%; pxa0=xa00.29), TVR (14.2 versus 10.8xa0%; pxa0=xa00.06) and MI (1.3 versus 1.9xa0%; pxa0=xa00.44) were not statistically different. These results persisted even after adjustment for different baseline characteristics, except MACCE that was no longer statistically significant.ConclusionData collected in DES.DE revealed that ULMCA PCI with DES result in similar TVR rates as compared to PCI in nLMCA. Moreover, modern DES have not offset the higher comorbidity index and higher procedure-related complication rate with PCI of ULMCA lesions.

Symptomatic abnormal vessel wall reaction after implantation of the first generation sirolimus-eluting stent: A case series

AIMSnExpansive vessel wall remodeling has been previously reported after implantation of drug-eluting stents. These abnormal vessel wall reactions (AVWR), though uncommon may be associated with serious clinical events. We report on a series of patients in whom symptoms developed despite patent stents.nnnMETHODS AND RESULTSnWe report a series of 10 consecutive patients with evidence of AVWR on angiography and/or intravascular ultrasonography after implantation of sirolimus-eluting stents (age 39-90 years, 4 females) during a period of 4 years. All patients were symptomatic despite patent stents in coronary angiographies done because of persistent chest pain. Four patients subsequently developed very late stent thrombosis (VLST). These 4 patients were only on aspirin monotherapy prior to the VLST. Of the remaining 6 patients, 3 patients underwent coronary interventions (with or without stenting) while the remaining 3 patients were managed conservatively. All 6 were advised for life-long dual antiplatelet therapy.nnnCONCLUSIONnThough uncommon, AVWR might precede VLST. In our series, all patients were symptomatic despite patent stents. Additional studies are required to identify patients at risk and to determine the best treatment modality for this challenging new entity. Until further data become available, these patients should stay on dual antiplatelet therapy after an AVWR has been identified.