Transcatheter aortic valve replacement with the 34 mm Medtronic Evolut valve : Early results of single institution experience.

OBJECTIVES: To report our experience with the recently introduced 34 mm Evolut transcatheter aortic valve replacement (TAVR) prosthesis. BACKGROUND: A larger TAVR prosthesis has become available for the treatment of aortic stenosis (AVS) in larger native aortic annuli (up to 30 mm). Outcomes with this new device are still unreported. RESULTS: The first 25 transfemoral TAVRs performed by our team with the self-expandable 34 mm Evolut are presented. The majority of patients were male (84%) with a mean age of 81.3 ± 5.6 years, a median logistic euro-SCORE of 14.7 (5.4-61.0), and a computed tomography measured mean perimeter-derived aortic annulus diameter of 27.1 ± 1.4 mm (min. 25.0-max. 31.2 mm). We implanted one 34 mm Evolut in all patients. Median operative time and radiation time were 68.5 and 12.4 min respectively. To optimise final valve position and haemodynamic performance, at least one complete re-sheathing and re-positioning of the same valve was reported in 33.2%. New permanent pacemaker implantation (PPMI) was necessary in 28.5%. At Receiver Operating Characteristic (ROC) analysis, a minimal diameter of the left ventricular outflow tract <21.9 mm was a significant predictor for PPMI (specificity 82%; sensitivity 83%; p = 0.005; Area Under the Curve (AUC) = 0.9). Length of stay in hospital was 9.2 ± 5.8 days and no in-hospital death was reported. At discharge, grade 1 + para-valvular regurgitation was present in 32%, and no regurgitation in the remaining patients. Device success and early safety were 100% and 92% respectively. CONCLUSIONS: TAVR with the 34 mm Evolut prosthesis has shown satisfactory acute outcomes. Although results are consistent with those observed with smaller Evolut prostheses, a trend for a higher PPMI rate has been noticed and could derive from a higher oversizing rate.

Mitro-aortic pathology: a point of view for a fully transcatheter staged approach.

Severe aortic valve stenosis (AVS) and mitral valve regurgitation (MVR) often coexist. Although a fully percutaneous treatment for the two conditions, by means of transcatheter aortic valve implantation (TAVI) followed by MitraClip, can be appealing in selected high-risk candidates, critical and strategical reasoning should be applied. In a 3-year period we have developed a single-centre experience of 14 patients who were managed with a staged percutaneous approach to treat severe AVS and MVR. The average interval from TAVI to MitraClip repair was 101 ± 12 days. Success for TAVI was 100% and 92.9% (13/14) for MitraClip. At late follow-up, 3 patients developed MVR 3+. Estimated 1­year survival was 66.5%. Freedom from 1­year endpoint (death, stroke, major bleeding, myocardial infarction, and cardiac re-hospitalisation) was 57.9%.In our view, a fully transcatheter approach for mitro-aortic pathology is feasible and should be performed only as a staged procedure in those patients that remain symptomatic, in spite of successful TAVI. It should be emphasised that although the periprocedural success rate is satisfactory, follow-up mortality and re-hospitalisation rates remain high, even at mid-term follow-up. This most probably results from the advanced clinical picture at time of referral for treatment.

MitraClip step by step; how to simplify the procedure.

The MitraClip system is a device for percutaneous edge-to-edge reconstruction of the mitral valve in patients with severe mitral regurgitation who are deemed at high risk for surgery. Studies have underlined the therapeutic benefit of the MitraClip system for patients at extreme and high risk for mitral valve surgery, suffering from either degenerative or functional mitral regurgitation. The MitraClip procedure shows low peri-procedural complication rates, and a significant reduction in mitral regurgitation, as well as an improvement in functional capacity and most importantly quality of life. It hereby widens the spectrum of mitral valve repair for the Heart Team. The current review underscores the efficacy of the procedure and describes the technique to simplify the procedure.

Introducing transcatheter aortic valve implantation with a new generation prosthesis: Institutional learning curve and effects on acute outcomes.

OBJECTIVES: We present our single-centre experience with the direct flow medical (DFM) trans-catheter aortic valve implantation (TAVI) prosthesis addressing the impact of learning curve upon outcomes. BACKGROUND: The DFM has been recently introduced for TAVI. The prosthesis presents original design and implantation features. METHODS: Patients were divided into three groups according to the chronological implantation sequence that reflected technical skills acquisition of the entire team. RESULTS: Group I included the first 20 patients (early learning phase), group II the second 20 patients (proctoring to other members of the team), and group III the following 93 patients (technique consolidation). Differences in baseline and procedural variables were analysed. Nonparametric correlation and linear regression were used to identify changes according to institutional cumulative experience. There was a significant correlation between catheterisation time and institutional experience (rho = -0.4; p < 0.0001) confirmed at linear regression (beta = -0.2; p = 0.001; CI: -0.3 - -0.08). Moreover, there was lower rate of valve retrieval in group III (15% vs. 20% vs. 10%; p = 0.5). No intra-procedural mortality was reported and improved early safety (at 30 days) was observed (80% vs. 85% vs. 87.1; p = 0.7). At hospital discharge, valve haemodynamic performance was satisfactory with only mild regurgitation in 10% (I), 20% (II), and 9.7% (III) (p = 0.8). CONCLUSIONS: DFM adequate sizing and implantation can be achieved after the early learning phases. A significant reduction in catheterisation time is reported after the first 20 patients. Results remain satisfactory during the proctoring and technical consolidation phase.

A Rare Clinical Course of Seronegative Pulmonary-Renal Syndrome.

Purpose. Pulmonary-renal syndrome (PRS) is characterized by diffuse alveolar hemorrhage and rapidly progressive glomerulonephritis mainly due to autoimmune etiologies. Seronegative PRS is a challenging entity to the clinician, since early diagnosis may be missed leading to delayed appropriate treatment. Materials and Methods. We present the clinical course of a 77-year-old patient who was admitted under the suspected diagnosis of pneumogenic sepsis and septic renal failure with fever, dyspnea, and elevated CRP levels. The diagnosis of pulmonary-renal syndrome was initially missed because of the absence of autoantibodies in all serological findings. Results. Despite delayed initiation of immunosuppressive therapy and a prolonged period of dialysis and extracorporeal membrane oxygenation the patient recovered well and was released to a rehabilitation center with nearly normalized creatinine levels. The diagnosis of PRS was established by renal biopsy. Conclusion. This case illustrates the important differential diagnosis of seronegative pulmonary-renal syndrome in patients with pulmonary and renal impairment.

[Interdisciplinary differential treatment of structural heart disease : When operation and when catheter-based intervention?]. / Interdisziplinäre Differenzialtherapie struktureller Herzerkrankungen : Wann Operation und wann kathetergestützte Intervention?

The demographic changes in society lead to an increasing number of patients with aortic valve stenosis and mitral regurgitation. Simultaneously the higher age of patients is associated with an increase in multimorbidity with a high surgical risk so that they cannot be referred to surgery. Besides the current gold standard of surgery, minimally invasive therapeutic options are increasingly becoming established for these patients. For the differentiated indications and therapeutic success, a multidisciplinary heart team assumes an important role. The next generation of transcatheter aortic valve implantation (TAVI) systems will lead to improvement in the results, lower complication rates and mortality and as a result there is a general trend towards expanding the indications. New innovative minimally invasive mitral valve devices are still undergoing clinical trials and will define future therapy options.

[We carry out too many TAVI - contra]. / Wir machen zu viele TAVI - Kontra.

Transcatheter aortic valve implantation (TAVI) is an established and approved procedure with an increasing implantation rate, whilst the number of surgical aortic valve replacements (SAVR) remained unchanged (AQUA data). This demonstrates that more patients who were unsuitable for SAVR were treated with TAVI. First randomized trials have shown a significant survival benefit for TAVI compared to conservative therapy (PARTNER B) and non-inferiority to SAVR in high-risk patients (PARTNER A). The US pivotal trials demonstrated even a significant survival benefit in TAVI patients compared to SAVR. The current 5-year data of the PARTNER trials demonstrate a long-term durability of the TAVI valves, which even have superior hemodynamic parameters. Increasing experience, optimization and evolution of the TAVI systems lead to better results and lower rates of complications and mortality, as was shown by the "real world data" from the German aortic valve registry (GARY). The analysis of the subgroups and also the Nordic aortic valve intervention (NOTION) study showed equivalent results for TAVI and SAVR in patients with intermediate and low risk. There is a trend to expand the indications to patients with intermediate risk and the currently ongoing large prospective and randomized trials SURTAVI and PARTNER II could provide greater clarity.

[Stent graft of the thoracic aorta]. / Stentversorgung der thorakalen Aorta.

Considering the demographic changes in our society and the proliferation of imaging-based improved diagnostics, both acute and chronic aortic diseases attract increasing attention and require dedicated care. Cardiac as well as vascular surgery used to represent the gold standards for therapeutic management of pathologies of the ascending aorta and the arch; however, the technological evolution of endoluminal strategies has had a serious impact on the treatment of the descending aorta, the aortic arch in combination with vascular debranching or bypass, and in selected cases even on managing pathologies of the ascending aorta. Although several case series and meta-analyses of published observations hint towards superiority of endografting in comparison to open surgical repair, the affected usually multimorbid patients with highly complex aortic disease should be subjected to an individual evaluation by a team of cardiologists, cardiac and vascular surgeons as well as imaging specialists; a dedicated individualized treatment concept in highly experienced centers of excellence is likely to provide the best results for such challenging patients.

Penetrating aortic ulcer, intramural hematoma, acute aortic syndrome: when to do what.

Acute aortic syndrome (AAS) is a modern term to describe interrelated emergency aortic conditions with similar clinical characteristics and challenges. These conditions include aortic dissection, intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Population-based studies suggest that the incidence of aortic dissection ranges from 2.6-3.5 cases per 100,000 person/year; hypertension and a variety of genetic disorders with altered connective tissue are the most prevalent risk conditions. One in eight patients diagnosed with acute aortic dissection has either an IMH or a PAU. Pain is the most commonly presenting symptom of acute aortic syndrome and should prompt immediate attention including diagnostic imaging modalities (such as multislice computed tomography, transesophageal ultrasound, or magnetic resonance imaging). IMH and PAU need a specific therapeutic approach, because without treatment they have a very poor evolution, are unpredictable and can be worse than acute aortic dissection. All patients must receive the best medical treatment available at admission. High-risk but asymptomatic patients with IMH and PAU can probably be followed-up without intervention. All symptomatic patients will need treatment. In many of these patients, a direct surgical approach is often prohibitive, due to age and multiple comorbidities. Endovascular treatment offers superior results and is becoming a recognized indication for patients. Irrespective of treatment modality, a close follow-up is mandatory in order to detect disease progression.

[Dynamic left ventricular outflow tract obstruction in pulmonary embolism]. / Dynamische Obstruktion des linksventrikulären Ausflusstrakts bei Lungenembolie.

Left ventricular hypertrophy, dehydration, sepsis, vasodilatation, excessive sympathetic stimulation, pericardial tamponade and surgical treatment of the atrioventricular valve are known causes of left ventricular outflow tract (LVOT) obstruction. We report the rare case of a patient who developed dynamic LVOT obstruction as a complication of acute pulmonary embolism.

Surface and intracardiac ECG for discriminating conduction disorders after CoreValve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been developed to minimize operative morbidity and mortality in high-risk symptomatic patients unfit for open surgery. With the proximity of the aortic valve annulus to the conduction system there is, however, an unknown risk of conduction disturbances necessitating monitoring and often cardiac pacing. MATERIALS AND METHODS: We enrolled 50 consecutive patients from January 2007 to 2008 in our prospective evaluation of conduction disturbances measured by surface and intracardiac ECG recordings. Baseline parameters, procedural characteristics as well as twelve-lead surface ECG and intracardiac conduction times were revealed pre-interventionally, after TAVI and at 7-day follow-up. RESULTS: TAVI was performed successfully in all patients. During 7 days of follow-up the rate for first-degree AV block raised from 14% at baseline to 44% at day 7 (p < 0.001), while rates for type II second- and third-degree were 0 versus 8% (p < 0.001) and 0 versus 12% (p < 0.001), respectively. Similarly, the prevalence of new left bundle branch block (LBBB) rose from 2 to 54% (p < 0.001). Intracardiac measurements revealed a prolongation of both AH and HV interval from 123.7 ± 41.6 to 136.6 ± 40.5 ms (p < 0.001) and from 54.8 ± 11.7 to 71.4 ± 20.0 ms (p < 0.001), respectively. Pacemaker implantation at a mean follow-up of 4.8 ± 1.2 days was subsequently performed in 23 patients (46%) due to complete AV block (12%) and type II second-degree AV block (8%) while another 13 patients (26%) received a pacemaker for the combination of new LBBB with marked HV prolongation. The high rate of first-degree AV block was primarily driven by an increase in HV interval. CONCLUSION: Cardiac conduction disturbances were common in the early experience with CoreValve implantation necessitating close surveillance for at least 1 week.

Enhanced mobilization of the bone marrow-derived circulating progenitor cells by intracoronary freshly isolated bone marrow cells transplantation in patients with acute myocardial infarction.

Autologous bone marrow cell transplantation (BMCs-Tx) is a promising novel option for treatment of cardiovascular disease. We analysed in a randomized controlled study the influence of the intracoronary autologous freshly isolated BMCs-Tx on the mobilization of bone marrow-derived circulating progenitor cells (BM-CPCs) in patients with acute myocardial infarction (AMI). Sixty-two patients with AMI were randomized to either freshly isolated BMCs-Tx or to a control group without cell therapy. Peripheral blood (PB) concentrations of CD34/45(+) - and CD133/45(+)-circulating progenitor cells were measured by flow cytometry in 42 AMI patients with cell therapy as well as in 20 AMI patients without cell therapy as a control group on days 1, 3, 5, 7, 8 and 3, 6 as well as 12 months after AMI. Global ejection fraction (EF) and the size of infarct area were determined by left ventriculography. We observed in patients with freshly isolated BMCs-Tx at 3 and 12 months follow up a significant reduction of infarct size and increase of global EF as well as infarct wall movement velocity. The mobilization of CD34/45(+) and CD133/45(+) BM-CPCs significantly increased with a peak on day 7 as compared to baseline after AMI in both groups (CD34/45(+): P < 0.001, CD133/45(+): P < 0.001). Moreover, this significant mobilization of BM-CPCs existed 3, 6 and 12 months after cell therapy compared to day 1 after AMI. In control group, there were no significant differences of CD34/45(+) and CD133/45(+) BM-CPCs mobilization between day 1 and 3, 6 and 12 months after AMI. Intracoronary transplantation of autologous freshly isolated BMCs by use of point of care system in patients with AMI may enhance and prolong the mobilization of CD34/45(+) and CD133/45(+) BM-CPCs in PB and this might increase the regenerative potency after AMI.

TEVAR: the solution to all aortic problems?

Chronic as well as acute diseases of the thoracic aorta are attracting increasing attention, both in the light of an ageing Western and Oriental population and with the proliferation of modern diagnostic imaging modalities. While classic surgical strategies still dominate the treatment of pathology of the ascending aorta and the proximal arch region, new endovascular concepts are emerging and are likely to evolve as primary treatment strategies for descending and abdominal aortic pathology. Additionally, aortic arch pathologies are becoming the target of hybrid approaches combining surgical head-vessel debranching and interventional stent-graft implantation in an attempt to improve outcome by avoiding the high risk of open arch repair or complete replacement. Nonetheless, due to the complexity of the underlying vascular disease, each patient should be discussed in a team consisting of cardiologists, cardiac surgeons, and an imaging specialist in order to design an individualized therapeutic strategy carried out best in a center with experience in both endovascular and surgical procedures.

Tratamiento en la disección aórtica torácica con prótesis endovascular / Treatment of the thoracic aortic dissection with stents

El tratamiento de endoprótesis endovascular para la disección aórtica aparece con buenos resultados a mediano tiempo. Las posteriores indicaciones, por ejemplo, tanto la disección del arco aórtico como las disecciones aórticas agudas no complicadas se encuentran bajo estudio.

O tratamento de endoprótese endovascular para a dissecção aórtica aparece com bons resultados a médio prazo. As posteriores indicações, por exemplo, tanto a dissecção do arco aórtico quanto as dissecções aórticas agudas não complicadas se encontram sob estudo.

Endovascular stent-graft therapy for aortic dissection is emerging with good midterm results. Further indications, i.e. aortic arch dissection and uncomplicated acute aortic dissections, are under evaluation.

Second- and third-generation drug-eluting coronary stents: progress and safety.

Drug-eluting stents (DES) have revolutionized the treatment of coronary artery disease by reducing the rate of in-stent restenosis from 20-40% with bare-metal stent (BMS) to 6-8% with DES. However, with widespread use of DES, safety concerns have risen due to the observation of late stent thrombosis. With this in mind and better understanding of mechanism and pathophysiology of stent thrombosis, the technological platform, especially innovative anti-restenotic agents, polymeric coatings, and stent platforms, improved with newer DES. Two second-generation DES, the Endeavor zotarolimus-eluting stent (ZES) and the Xience-V everolimus-eluting stent (EES), have provided promising results in both randomized controlled trials (SPIRIT and ENDEAVOR) and registries (E-Five, COMPARE) compared with bare-metal stents (BMS) and first-generation DES. Newer third-generation stent technology, especially biodegradable polymers, polymer-free stents, and biodegradable stents on the basis of poly-L-lactide (PLLA) or magnesium, has been evaluated in preclinical and initial clinical trials. However, despite encouraging initial results, long-term data of large-scale randomized trials as well as registries comparing them to currently approved first- and second-generation DES are still lacking.

Improved functional activity of bone marrow derived circulating progenitor cells after intra coronary freshly isolated bone marrow cells transplantation in patients with ischemic heart disease.

OBJECTIVES: There is growing evidence that intracoronary autologous bone marrow cells transplantation (BMCs-Tx) in patients with chronic myocardial infarction beneficially affects postinfarction remodelling. In this randomized controlled study we analyzed the influence of intracoronary autologous freshly isolated bone marrow cells transplantation by use of point of care system on cardiac function and on the functional activity of bone marrow derived circulating progenitor cells (BM-CPCs) in patients with ischemic heart disease (IHD). METHODS: 56 patients with IHD were randomized to either received freshly isolated BMC-Tx or a control group that did not receive cell therapy. The functional activity of BM-CPCs in peripheral blood (PB) was measured by migration assay and colony forming unit assay pre- and 3, 6 as well as 12 months after procedure. Global ejection fraction (EF) and infarct size area were determined by left ventriculography. RESULTS: Intracoronary transplantation of autologous freshly isolated BMCs led to a significant reduction of infarct size and an increase of global EF as well as infarct wall movement velocity after 3 and 12 months follow-up compared to control group. The colony-forming capacity of BM-CPCs significantly increased 3, 6 and 12 months after cell therapy compared to pre BMCs-Tx and control group (CFU-E: p < 0.001, CFU-GM: p < 0.001). Likewise, we found significant increase of migratory response to stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor (VEGF) after cell therapy compared to pre BMCs-Tx (SDF-1: p < 0.001, VEGF: p < 0.001) and to control (SDF-1: p < 0.001, VEGF: p < 0.001). There was no significant difference of migratory- and colony forming capacity between pre- and 3, 6, 12 months after coronary angiography in control group without cell therapy. CONCLUSIONS: Intracoronary transplantation of autologous freshly isolated BMCs by use of point of care system may lead to improvement of BM-CPCs functional activity in peripheral blood, which might increase the regenerative potency in patients with IHD.