Christian Thilo

Overexpansion of the SAPIEN 3 Transcatheter Heart Valve : A Feasibility Study

The Edwards SAPIEN 3 (S3) (Edwards Lifesciences Inc., Irvine, California) is the latest iteration of the balloon-expandable transcatheter heart valve (THV) with several new features designed to address the limitations of earlier generation devices. An initial feasibility study performed in Europe

Bicuspid aortic valve stenosis with successful transfemoral transcatheter aortic valve replacement (TAVI) using the Sapien 3 valve

An 80-year-old woman with coronary artery disease status post bypass surgery, pulmonary hypertension, and permanent atrial fibrillation presented with symptoms of dyspnoea (New York Heart Association class IV). She was found to have a severely stenotic bicuspid aortic valve (AV). Coronal ( Panel A ), sagittal ( Panel B ), and transverse axis ( Panel C , upper image) CT angiogram images reveal a …

Variables associated with disability in male and female long-term survivors from acute myocardial infarction. Results from the MONICA/KORA Myocardial Infarction Registry

Increasing attention is paid on functional limitations and disability among people with chronic diseases. However, only few studies have explored disability in persons with acute myocardial infarction (AMI). The objective of this study was to provide a description of disability and to identify determinants of disability in a population-based sample of long-term AMI survivors. The sample consisted of 1943 persons (35-85years) with AMI from the German population-based MONICA/KORA Myocardial Infarction Registry, who responded to a postal follow-up survey in 2011. Disability was assessed with the 12-item version of the World Health Organization Disability Schedule (WHODAS). Multivariate linear regression models were established in order to identify socioeconomic and clinical factors, risk factors and comorbidities which are associated with disability. The mean WHODAS score for the total sample was 7.86±9.38. The regression model includes 26 variables that explained 37.2% of the WHODAS variance. Most of the explained variance could be attributed to the presence of depression, female sex, joint disorders, digestive disorders, and stroke. Depression was the most important determinant of disability in both sexes. Replacement of single comorbidities by the total number of comorbidities resulted in a model with 15 variables explaining 31.9% of the WHODAS variance. Most of the variance was explained by the number of comorbidities. Further significant determinants of disability were female sex, low education level, angina pectoris, and no revascularization therapy. In AMI patients, the number of comorbidities and particularly the presence of depression are important determinants of disability and should be considered in post-AMI health care.

Presenting symptoms, pre-hospital delay time and 28-day case fatality in patients with peripheral arterial disease and acute myocardial infarction from the MONICA/KORA Myocardial Infarction Registry

Background Previous studies have indicated that patients with acute myocardial infarction (AMI) who have a history of peripheral arterial disease (PAD) have different characteristics and poorer outcomes than patients without PAD. However, data on short-term mortality are conflicting and it is unclear whether patients with PAD have a different scope of AMI symptoms or differences in pre-hospital delay time (PHDT) compared with patients without PAD. The objective of this study was to determine the associations between a history of PAD and presenting AMI symptoms, PHDT and 28-day case fatality in a population-based sample of patients with AMI. Design This was an observational study. Methods Information on history of PAD was obtained from the patients’ medical records and their AMI symptoms were assessed by interviews with patients. Multivariable logistic regression models were used to determine the association of PAD with AMI symptoms and 28-day case fatality. A multivariable linear regression model was developed to examine the relations between PAD and PHDT. Results From the 5848 patients with AMI included in this study, 9.8% had a history of PAD. Patients with PAD were significantly less likely to report chest symptoms (odds ratio (OR) 0.52, 95% confidence interval (CI) 0.41–0.66) or pain in the upper left extremity (OR 0.67, 95% CI 0.54–0.84) than patients without PAD. PAD was significantly related with longer PHDT in patients <69 years of age (p = 0.0117) and men (p = 0.0104). A significantly higher 28-day case fatality (OR 2.09, 95% CI 1.47–2.96) was found in patients with PAD compared with patients without PAD. Conclusions Patients with PAD should receive comprehensive education on the possibility of atypical AMI symptoms and the need to call emergency medical services immediately.

Fluoroscopic calcification-guided optimal deployment projection during transcatheter aortic valve replacement--"The eye of the pigtail." (Follow the right cusp rule--Part II).

Transfemoral transcatheter aortic valve replacement (TAVR) has evolved significantly over the last decade. Various imaging modalities play a critical role in the assessment and management of the TAVR patients. Aortic root angiograms, multiple detector computed tomography (MDCT), and C-arm rotational angiography using DynaCT (Siemens AG, Munich, Germany) are the most common imaging modalities used to obtain the optimal deployment projection (ODP) [1–3]. We describe how to predictably and successfully obtain the ODP under fluroscopy using the aortic valve (AV) calcification as guidance. To obtain the ODP, first identify the calcification outlining the aortic cusps and the opening movements of leftand non-coronary cusp which is usually visible under fluroscopy in a posterior–anterior projection. Place a curved pigtail catheter in the right coronary cusp and bring the opening movement in the “eye” of the Pigtail catheter by using the Right Cusp Rule as described previously [4] (Fig. 1A and B). From January 2013 until February 2014, we evaluated the procedural and clinical outcomes of a 129 consecutive patients with severe aortic stenosis (AS) who underwent transfemoral TAVR with an Edwards Sapien valve (Edwards Lifesiences, Irvine, CA). The ODP for all cases were derived using our described fluoroscopic technique. The primary endpoint was the amount of contrast used to obtain the ODP. The secondary endpoints were device success, acute kidney injury (AKI), and in-hospital mortality. The ODP was obtained successully in all patients with a mean contrast volume of 25.5 13.6 mL (Fig. 2). Device success was achieved in 99% of our patients. AKI was noted in four patients (3.1%) of which only one (0.8%) had stage 3 kidney disease. One patient (0.8%) died during the primary hospitalization from an aortic annulus rupture. Kasel et al. [4] described how to use fluoroscopy to define the perpendicular annulus plane and to obtain the alignment of the right cusp in one line between leftand non-coronary cusps. We took this “Follow the Right Cusp” rule a step further by describing how to use the calcification outlining the aortic cusps, as seen under fluoroscopy, to guide us in obtaining the ODP before taking the first bulbous angiogram; this minimizes the amount of contrast and number of angiograms performed to obtain the ODP. Knowing how to obtain the ODP with fluoroscopic assessment plays a vital role in situations where MDCT derived data is not available, or is innacurate. The amount of contrast generally used with MDCT examination is 80–120 mL [1,2], and 3D reconstruction with DynaCT requires from 20 mL to 32 mL of contrast media [1]. The need for rapid pacing and breath hold before the contrast injection with DynaCT [1] make it a less desirable option for obtaining the ODP. The majority of patients undergoing TAVR are elderly with multiple comorbidities, poor left ventricular function, and more prone to kidney injury; therefore, it is important to reduce the contrast load during the procedure and avoid deleterious steps such as rapid pacing. Our technique of using valve calcification, when present, to set up the ODP under fluroscopy, and then adjusting the angulation using the “Follow the Right Cusp” rule provides a means to successfully obtain the ODP without the need for rapid pacing and with minimal contrast amount. Our high device success rate, low rates of in-hospital mortality, and AKI shows that our technique is feasible and safe.

Successful management of cerebral embolism during TAVR

An 89-year-old woman underwent transfemoral aortic valve replacement (TAVR) for treatment of severe symptomatic aortic stenosis as recommended by the institutional heart team (transvalvular gradient max 71 mmHg/mean 55 mmHg). Aortic annulus size as determined by computed tomography (CT) was 19 mm with moderate calcifications. Accordingly, a 23 mm Edwards Sapien XT valve (Edwards Lifesciences) was selected. The patient was preloaded with 500 mg Aspirin and 100 IE/kg of unfractionated heparin was given during the procedure. After successful implantation of the valve under conscious sedation, the patient presented with right sided hemiplegia and aphasia. The patient was immediately transferred from the cath lab to cerebral CT angiography which revealed complete occlusion of the M1 branch of the left middle cerebral artery (ACM). After transfer to the neuroradiology intervention room, intubation, and reaccess to the left femoral artery, a catheter was placed in the left carotid artery confirming the occlusion and sufficient collateralization (Fig. 1a). Contrast injection via a microcatheter after passage of the occlusion with a microwire demonstrated correct positioning (Fig. 1b). Subsequently, a Solitaire 4 9 20 mm Stent Retriever (Covidien) was placed in the occluded segment and released for 5 min. Contrast injection assessed filling of the stent retriever (Fig. 2a). Subsequently, the device was retrieved and substantial thrombotic material was attained (Fig. 3). The final angiogram revealed complete restoration of flow (Fig. 2b). The patient was extubated after the procedure and mobilized on the next day without any residual neurological pathology. Cerebral embolization is a critical complication of TAVR [1]. Successful neurovascular rescue was recently described in a patient with stroke after TAVR performed in general anesthesia [2]. Conduction of TAVR under conscious sedation, however, allows for rapid assessment of neurological symptoms during and after the procedure. Timely diagnosis of cerebral ischemia facilitates immediate and full restoration of cerebral flow.

Factors Associated With Emergency Services Use by Patients With Recurrent Myocardial Infarction: From the Monitoring Trends and Determinants in Cardiovascular Disease/Cooperative Health Research in the Region of Augsburg Myocardial Infarction Registry.

Background: Although emergency medical services (EMS) use is the recommended mode of transport in case of acute coronary symptoms, many people fail to use this service. Objective: The objective of this study was to determine factors associated with EMS use in a population-based sample of German patients with recurrent acute myocardial infarction (AMI). Methods: The sample consisted of 998 persons with a first and recurrent AMI, recruited from 1985 to 2011. Logistic regression modeling adjusted for sociodemographic, situational, and clinical variables, previous diseases, and presenting AMI symptoms was applied. Results: Emergency medical services was used by 48.8% of the patients at first, and 62.6% at recurrent AMI. In first AMI, higher age, history of hyperlipidemia, ST-segment elevation AMI, more than 4 presenting symptoms, symptom onset in daytime, and later year of AMI were significantly related with EMS use. Pain in the upper abdomen and pain between the shoulder blades were significantly less common in EMS users. In recurrent AMI, EMS use at first AMI, presence of any other symptom except chest pain, ST-segment elevation myocardial infarction, and later year of AMI were significantly related with EMS use. Significant predictors of EMS use in recurrent AMI in patients who failed to use EMS at first AMI were unmarried, experience of any symptom except chest symptoms at reinfarction, bundle branch block (first AMI), any in-hospital complication (first AMI), longer duration between first and recurrent AMI, and later year of reinfarction. Conclusions: Patients with AMI and their significant others may profit by education about the benefits of EMS use.

Current and future applications of CT coronary calcium assessment

ABSTRACT Introduction: Computed tomographic (CT) coronary artery calcium scoring (CAC) has been validated as a well-established screening method for cardiovascular risk stratification and treatment management that is used in addition to traditional risk factors. The purpose of this review is to present an update on current and future applications of CAC. Areas covered: The topic of CAC is summarized from its introduction to current application with focus on the validation and clinical integration including cardiovascular risk prediction and outcome, cost-effectiveness, impact on downstream medical testing, and the technical advances in scanner and software technology that are shaping the future of CAC. Furthermore, this review aims to provide guidance for the appropriate clinical use of CAC. Expert commentary: CAC is a well-established screening test in preventive care that is underused in daily clinical practice. The widespread clinical implementation of CAC will be decided by future technical advances in CT image acquisition, cost-effectiveness, and reimbursement status.

Peripheral arterial disease is associated with higher mortality in patients with incident acute myocardial infarction

BACKGROUND Little data is available on short- and long-term survival in patients with peripheral arterial disease (PAD) after acute myocardial infarction (AMI). We aimed to examine the association of PAD and 28-day case fatality as well as long-term mortality in a population-based sample of patients with incident AMI. METHODS In this secondary analysis of data from the German MONICA/KORA Myocardial Infarction Registry 4307 patients aged 28-74years with incident AMI with and without history of PAD (information derived from medical chart) were included. Data were collected between 2000 and 2008. Patients were followed-up until December 2011. Associations between PAD and 28-day case fatality were examined via multivariable logistic regression models, between PAD and long-term mortality with Cox proportional hazards regression models, respectively. RESULTS From 303 (8.9%) patients with PAD, 22 (7.3%) died within 28-days post-AMI in contrast to 96 (2.9%) of patients without PAD. However, the fully adjusted model (OR 1.55, 95% CI 0.89-2.70) revealed no significant association. Long-term follow-up (median 5.7years) yielded 100 (32.4%) versus 483 (14.4%) cases of deaths among patients with and without PAD, respectively. This association was significant (fully adjusted model: HR 1.70, 95% CI 1.35-2.13), persisted up to 11years after AMI and was present in all subgroups according to age, sex and history of diabetes. The highest long-term mortality risk was found for patients younger than 63years with PAD (HR 2.19; 95% CI 1.41-3.39). CONCLUSION AMI patients with PAD differ considerably from their counterparts without PAD in terms of long-term survival.

Late migration of Edwards SAPIEN 3 transcatheter heart valves: mechanisms and transcatheter treatment options for a rare phenomenon

Over the last decade, transcatheter aortic valve implantation (TAVI) has evolved from a challenging intervention in inoperable patients to a standardized minimalistic procedure in lower risk patients with high procedural success rates [1]. However, several TAVI-specific complications require special attention [2–4]. Valve migration is a rare, but serious complication, which mostly occurs early (< 1 h) after TAVI [5]. We report a case series of three patients with late valve migration of the SAPIEN 3TM valve (Edwards Lifesciences, Irvine, CA, USA) and provide different mechanisms and transcatheter treatment options (Fig. 1). A 78-year-old male patient underwent transfemoral TAVI for severe aortic stenosis (AS). A 26 mm Edwards SAPIEN 3 (S3) transcatheter heart valve (THV) was deployed based on pre-procedural multislice-computed tomography (MSCT) mean annulus diameter of 23.0 mm (annulus area 410 mm2). Although the S3 valve was placed in a deep position (60% aortic and 40% ventricular), the final angiography showed a good functional result with only trace paravalvular leakage (PVL). Echocardiography 1 day after the procedure showed satisfactory THV function (PVL I°–(II)°, mean gradient 16 mmHg). At 30-day follow-up, echocardiography demonstrated worsened valve function (PVL II°–III°, mean gradient 18 mmHg), and revealed a slight migration of the bioprosthesis from an intra-annular position towards the left ventricular outflow tract. Further imaging with MSCT confirmed these findings. Deep initial positioning of the intra-annular THV is likely to have accounted for valve migration. Re-intervention was indicated to avoid further valve migration and balloon post-dilatation with overexpansion was chosen, as previously described [6]. Overexpansion was performed with a 26 mm deployment balloon (nominal deployment volume + 4 ml), resulting in an upwards repositioning of the THV due to valve frame foreshortening from the ventricular end. Intraprocedural angiography and postinterventional echocardiography showed improved prosthesis function (PVL < I°, mean gradient 13 mmHg), which remained unchanged after 2-month follow-up. Reason for migration: Borderline valve size and implantation height. An 83-year-old male patient underwent successful transfemoral TAVI for severe AS in an external center. A 23 mm S3 THV was deployed based on pre-procedural CT mean annulus diameter of 22.2 mm (annulus area 339 mm2). Four months later, he was admitted to our emergency department with dyspnea (NYHA class III). Echocardiography showed normal transvalvular gradients (mean gradient 14 mmHg) and severe PVL. Transesophageal echocardiography and MSCT demonstrated marked migration of the THV towards the left ventricle with a sub-annular position of the prosthesis skirt. Re-evaluation of the initial CT suggested a true mean annulus diameter of 23.7 mm (annulus area 446 mm2), suggesting deployment of a 26 mm S3 model. Therefore, undersizing of the initial THV due to poor imaging quality was most likely the reason for valve migration. Repeat procedure was indicated to avoid further valve migration. The chosen treatment strategy was to perform a transfemoral valve-in-valve TAVI with a larger THV (26 mm S3). Intraprocedural angiography and post-interventional echocardiography revealed excellent short-term results with good prosthesis function (PVL < I°, mean gradient 13 mmHg). Freedom from symptoms and good valvular function were maintained at 30-day and 6-month follow-up. Reason for migration: Udersizing of chosen THV. * Albert Markus Kasel markus_kasel@web.de