Anatomical suitability and off-label use of contemporary transcatheter heart valves.

BACKGROUND: Despite excellent procedural results in a broad clinical population, certain anatomical or clinical conditions are still challenging for transcatheter aortic valve replacement (TAVI). Whether the adherence to the instructions for use (IFU) or the use of a clinically suitable device is a prerequisite for procedural success has not been well characterized. AIMS: The anatomical and clinical suitability of new-generation transcatheter heart valves (THV) was evaluated in an all-comers population (n = 540) at a high-volume center. METHODS: Conformity with anatomical IFU criteria was evaluated in each implanted THV. In addition, the suitability of the implanted THV was verified in each case according to clinical and anatomical criteria, which had been previously defined according to the results of an international survey including 20 renowned TAVI operators. Furthermore, criteria of clinical suitability and adherence to IFU of each THV were applied to the overall cohort to analyze the proportion of patients in whom the use of the respective THV would have been judged to be unsuitable or off-label. RESULTS: An off-label use of THV based on anatomical considerations was found in 20% of all procedures, whereas the implantation of a THV deemed to be clinically unsuitable was noted in 16.3% of all procedures. Clinical suitability and conformity with IFU were present to a varying extent across the THV systems. Neither clinical suitability, nor conformity with IFU were associated with device failure or periprocedural mortality. On multivariable analysis, aortic tortuosity, mean transaortic gradient and ascending aorta diameter were identified as independent predictors of device failure (VARC-3). CONCLUSIONS: Off-label TAVI and the use of clinically unsuitable THVs were common, but did not affect procedural outcomes. The variety of clinical and anatomical coverage of the different THV systems emphasizes the importance of an individualized THV selection.

Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in Patients at Very High or Prohibitive Surgical Risk: A Single-Center Experience.

BACKGROUND: Mitral valve surgery in patients with failing bioprosthesis, annuloplasty rings, or in patients with advanced mitral annular calcification (MAC) is associated with high morbidity and mortality rates. Percutaneous antegrade transseptal transcatheter mitral valve implantation (TMVI) has recently successfully been performed in those patients at high or prohibitive surgical risk, but data on patients treated by TMVI are sparse. This study sought to evaluate short- and midterm outcomes of patients treated by TMVI at our site in clinical practice. METHODS AND RESULTS: From October 2016 to February 2018, seven patients (six women and one man) at high or prohibitive surgical risk underwent TMVI at our site. Three procedures were performed as TMVI in failed mitral valve bioprostheses (TMVI-VIV, "valve-in-valve"), one procedure was performed as TMVI in a failed mitral annuloplasty ring (TMVI-R), and three procedures were performed as TMVI in advanced native mitral annular calcification (TMVI-MAC). Mean age of the population treated was 77 ± 8.1 years, and mean log EuroScore I was 39 ± 0.12%. In all patients, an Edwards SAPIEN 3 transcatheter heart valve was implanted under 3D-TOE and fluoroscopic guidance using a transvenous/transseptal access. Indication for TMVI was the presence of advanced heart failure symptoms in all patients (NYHA class III/IV). The predominant dysfunction of the mitral valve treated was severe regurgitation in 72% (n = 5) and severe stenosis in 29% (n = 2) of all patients. TMVI was technically successful in all procedures. Clinical success with functional improvement of at least one NYHA class after procedure compared with before procedure was also achieved in all patients. Median NYHA class improved significantly from 4 before procedure to 2 after TMVI (p=0.008). Mitral valve regurgitation was reduced to trace or mild in all but one patient, who showed moderate MR after TMVI-MAC. No patient-prosthesis mismatch or LVOT obstruction occurred after TMVI. Two patients underwent interventional ASD closure during the in-hospital course due to a large and persisting atrial septal defect after transseptal access. One patient underwent pacemaker implantation due to complete AV-block after TMVI. One patient died in hospital 12 days after the procedure due to severe hospital-acquired pneumonia and sepsis. In-hospital mortality rate was 14% (1/7) in this high-risk population. After hospital discharge, no death occurred and clinical improvement-according to NYHA functional class-remained stable during one-year follow-up. CONCLUSION: In this small single-center series, TMVI appears promising for patients at high or prohibitive surgical risk with either failing mitral bioprostheses/annuloplasty rings or native mitral valve dysfunction in combination with advanced MAC. Gaining experience in TMVI and new valves will further improve safety and efficacy of this new treatment option.

Prognostic relevance of new onset arrhythmia and ICD shocks in primary prophylactic ICD patients.

BACKGROUND: The prognostic relevance of new onset arrhythmias compared to ICD shocks in ICD patients is not well known. OBJECTIVES: Aim of the study was to evaluate the prognostic relevance of new onset atrial fibrillation (AF) or ventricular arrhythmias (VT/VF) compared to ICD shocks in primary prophylactic ICD-patients. METHODS: A total of 622 of 1955 (32%) patients of the prospective single-centre ICD-registry Ludwigshafen with primary prophylactic ICD indication and sinus rhythm (SR) at baseline without history of AF were analyzed. All patients underwent an ICD implantation between 1992 and 2012. RESULTS: During the median follow-up time of 6 years, 200 (32%) ICD patients developed new AF and 249 (40%) patients new VT/VF. There was an approximately 10% increase of 5-year mortality rate depending on the type of new onset arrhythmia (no arrhythmia 19%, new AF 28%, new VT 36% and new VF 55% 5-year mortality). In a multivariate analysis, new onset of AF or VT/VF was an independent predictor for increased mortality whereas VT shocks and inappropriate ICD shocks were not. CONCLUSION: More than half of primary prophylactic ICD patients with SR at baseline develop new AF or VT/VF after 6 years. New onset arrhythmias of AF and VT/VF are independent prognostic factors for increased mortality in primary prophylactic ICD patients. ICD shocks itself, inappropriate or appropriate, are not additionally associated with a worse outcome. These results support the hypothesis that in clinical practice rather the arrhythmia than the ICD shock itself is responsible for a deteriorated prognosis.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Procedural Success Rates and Mortality in Elderly Patients With Percutaneous Coronary Intervention for Cardiogenic Shock.

OBJECTIVES: The aim of this study was to determine the impact of age on procedural and clinical outcomes in patients with cardiogenic shock (CS). BACKGROUND: The use of early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcome in patients with acute myocardial infarction (AMI) complicated by CS. METHODS: Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry were centrally collected and analyzed. Patients were divided into 4 groups according to their age (<65, 65 to 74, 75 to 84, and >85 years). Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared among the 4 groups. RESULTS: Between 2010 and 2015, a total of 2,323 consecutive patients with AMI and CS were treated by PCI in 51 hospitals. TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 patency after PCI decreased with increasing age from 84% to 78%, while in-hospital mortality increased from 32% to 56%. Bleeding rates were low (2.0% to 2.3%) and not different among age groups. In the multivariate analysis, higher age, TIMI flow grade <3 after PCI, 3-vessel disease, and left main PCI were independent predictors of mortality. CONCLUSIONS: PCI in patients with AMI and CS is associated with a high procedural success rate and a low bleeding rate, even in very elderly patients, while mortality increases with increasing age. Because mortality in elderly patients with CS without revascularization therapy is very high, it seems justified to perform PCI in selected patients to reduce mortality.

Long-term performance and lead failure analysis of the Durata defibrillation lead compared to its previous model, the recalled Riata defibrillation lead.

INTRODUCTION: Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice. METHODS AND RESULTS: A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%). CONCLUSION: Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice.

Contemporary benefit-harm profile over two decades in primary prophylactic ICD-therapy.

BACKGROUND: Implantable cardioverter defibrillator (ICD) was implemented into clinical routine more than 20 years ago. Since then, ICD therapy became standard therapy for primary and secondary prevention of sudden cardiac death in clinical practice. OBJECTIVES: Aim of the study was to evaluate the benefit-harm profile of contemporary primary prophylactic ICD therapy. METHODS: A total of 1222 consecutive patients of a prospective single-center ICD-registry were analyzed who underwent primary prophylactic ICD implantation between 2000 and 2017. Patients were divided into two groups according to the implantation year: 2010-2017 (group 1, n = 579) and 2000-2009 (group 2, n = 643). RESULTS: The rate of estimated appropriate ICD therapy after 8 years was 51% in the 2000s and 42% in the 2010s (P < .001). The complication rate changed slightly from 53% to 47% (P = .005). This decline was mainly driven by the reduction of inappropriate ICD shocks (30% vs 14%, P < .001) whereas the rate of ICD shock lead malfunction and device/ lead infection remained unchanged over time. Nonischemic cardiomyopathy was an independent predictor for ICD complications without benefit of ICD therapy (HR 1.37, 95% CI 1.07-1.77). CONCLUSION: The ICD therapy rate for ventricular arrhythmias in patients with primary prophylactic ICD implantation is decreasing over the last two decades. Complication rate remains high due to an unchanged rate of ICD shock malfunctions and device infections. Nonischemic cardiomyopathy is an independent predictor for ICD complications without benefit of ICD therapy in primary prophylactic ICD-therapy.

Patients at Intermediate Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Implantation for Severe Symptomatic Aortic Valve Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%-8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

Interventional treatment of paravalvular regurgitation by plug implantation following prosthetic valve replacement: a single-center experience.

BACKGROUND: Interventional closure of paravalvular leaks (PVL) by plug implantation has emerged as an alternative to surgical correction, which is associated with high mortality rates for re-operation. To date, data on procedural efficacy and clinical outcome after transcatheter closure is sparse. We present our experience with interventional PVL closure at our site. METHODS AND RESULTS: From 08/2014 to 10/2016 ten patients (three women, seven men) at high surgical risk for repeat surgery underwent interventional PVL closure for severe paravalvular regurgitation (PVR) in 14 procedures at our site. Nine procedures (64%) were performed for mitral PVLs, five procedures were performed for aortic PVLs (36%). Mean age of the population treated was 70 ± 8.6 years and mean log. Euro-Score I was 27.4 ± 14.9%. All patients were treated by implantation of Amplatzer Vascular Plug III occluders. All aortic PVLs were treated using a retrograde transfemoral access, mitral PVLs were treated using either a transseptal (8/9) or transapical access (1/9) under 3-dimensional transesophageal echocardiographic and fluoroscopic guidance. Indication for PVL closure was the presence of severe heart failure symptoms in all patients (NYHA class III/IV, n = 14) and additional mechanical hemolytic anemia (n = 5) with a need for transfusion. Interventional closure of PVL was completely successful in 12 procedures (85%), partially successful in one procedure due to inability to cross the defect with a wire (7.5%) and failed in one of 14 procedures due to inability of plug deployment in a very large defect (7.5%). One patient in a critical clinical condition died within 24 h after procedure due to progressive cardiogenic shock after procedural failure and refusal of a surgical treatment by cardiac surgeons. After interventional treatment clinical success with improvement in NYHA functional class or hemolysis was achieved in 93% (13/14). Median NYHA class improved significantly from 4 prior to procedure to 2 after PVL closure (p = 0.0005). Severe PVR was significantly reduced to mild in six patients and to moderate in three patients after procedure (p = 0.001). Complications included one hemothorax after transapical access and one pseudoaneurysm after transfemoral arterial access. In-hospital mortality rate was 20% (2/10) in this high-risk population. After hospital discharge no death occurred during 30-day follow-up, one patient died during 1-year follow-up after PVL closure. CONCLUSION: In this single-center series interventional PVL closure appears promising for patients at high surgical risk with symptomatic paravalvular regurgitation. Gaining experience in interventional PVL closure at specialized sites will further improve safety and efficacy of this relatively new treatment option. All patients should be treated within large clinical registries to gain more data on mid- and long-term efficacy of transcatheter PVL closure.

Matched comparison of next- and early-generation balloon-expandable transcatheter heart valve implantations in failed surgical aortic bioprostheses.

AIMS: Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves. METHODS AND RESULTS: After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071). CONCLUSIONS: Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.

Five-year follow-up after transcatheter aortic valve implantation for symptomatic aortic stenosis.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of long-term mortality need to be evaluated to better select patients. Therefore, we aimed to analyse predictors of 5-year mortality after TAVI. METHODS: We analysed data from the German Transcatheter Aortic Valve Interventions-Registry. Each of the 27 participating hospitals agreed to include all consecutive TAVI patients at their institution. Out of 1444 patients treated with TAVI, 1378 patients had a follow-up of at least 4.5 years (completeness 95.4%). Endpoint for this analysis was 5-year survival. Cox regression analysis was used to determine risk factors associated with this endpoint. RESULTS: Patients who died were compared with survivors. The two groups showed multiple differences in patient characteristics, indications for interventions, preinterventional, as well as interventional characteristics and postinterventional events. Calculated 1-year mortality was 21.8% and 5-year mortality 59.1%. A higher logistic EuroScore was associated with a lower 5-year survival, being 45.5% in patients with a logistic EuroScore of <20%, 34.5% in those with 20% to 40% and 28.4% in patients with a logistic EuroScore >40%. Cox proportional hazard analysis revealed the following independent predictors of 5-year mortality: female gender (HR =0.66, 95% CI 0.56 to 0.77, p<0.0001), renal failure (HR=1.43, 95% CI 1.22 to 1.69, p<0.0001), prior mitral regurgitation ≥II° (HR=1.42, 95% CI 1.21 to 1.65, p<0.0001), residual aortic regurgitation ≥II° (HR=1.52, 95% CI 1.24 to 1.85, p<0.0001), atrial fibrillation (HR=1.38, 95% CI 1.18 to 1.64, p=0.0001), low gradient aortic stenosis (HR=1.48, 95% CI 1.19 to 1.84, p=0.0004), prior decompensation (HR=1.32, 95% CI 1.13 to 1.54, p=0.0006), frailty (HR=1.31, 95% CI 1.09 to 1.58, p=0.004), surgical TAVI (HR=1.42, 95% CI 1.12 to 1.80, p=0.004), age (by year) (HR=1.02, 95% CI 1.01 to 1.03, p=0.006), prior myocardial infarction (HR=1.29, 95% CI 1.07 to 1.57, p=0.009), urgent TAVI (HR=1.25, 95% CI 1.04 to 51, p=0.020) and diabetes mellitus (HR=1.20, 95% CI 1.02 to 1.40, p=0.024). CONCLUSIONS: These data from the early TAVI experience show a 5-year mortality of 59.1%. Some of the predictors of 5-year mortality seem to be modifiable, such as residual aortic regurgitation, type of TAVI access route and concomitant mitral regurgitation.

Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for patients with severe, symptomatic aortic valve stenosis at high surgical risk over the last years. However, besides its minimal invasive character, TAVI still is an invasive procedure usually performed in a population, carrying a substantial risk for vascular complications, like stroke. Stroke is known to be a rare but serious complication of transvascular interventions in clinical practice, which is associated with high morbidity and mortality rates. Despite broad clinical research in many fields of TAVI over the last years, only sparse data still exist on the incidence and clinical risk factors of stroke complicating TAVI in clinical practice today. METHODS: We analyzed data of 1.413 TAVIs, which were enrolled at 30 sites into the prospective and multicenter German TAVI Registry from January 2009 until June 2010. RESULTS: The overall incidence of cerebrovascular events complicating TAVI was 3.2% (n = 45/1.413) in a real-world population today. 40% of all cerebrovascular events were classified as transient ischemic attacks (TIA) with symptoms lasting < 24 hr (18/45) and 60% were classified as stroke with symptoms persisting > 24 hr (27/45). All strokes complicating TAVI of 50% were classified as major strokes leading to notable disability in patients, who survive this complication (Modified Ranking Scale 3-6). In-hospital mortality rate in patients with stroke/TIA was 28.9%, compared to 6.9% in patients without stroke/TIA and 1-year mortality rate 46.7% versus 18.6%, respectively. In multivariate analysis, prior stroke and renal impairment were found as the only independent predictors for stroke complicating TAVI. CONCLUSIONS: Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

[Catheter-based closure of paravalvular leaks: "Plug the hole"]. / Interventionelle Therapieoptionen paravalvulärer Leckagen : "Plug the hole".

Paravalvular leak (PVL) is a relatively rare, but serious complication occurring in up to 10% of patients after prosthetic aortic valve replacement and in up to 17% of patients after prosthetic mitral valve replacement. Up to 5% of patients will present with symptoms of congestive heart failure or mechanical haemolytic anaemia due to PVL and need further surgical or interventional treatment. Surgical repair is often technically challenging and carries a high mortality and morbidity risk. Catheter-based closure of PVL has emerged as an alternative approach especially for patients with relevant comorbidities at high surgical risk. Interventional closure of PVL is a complex procedure, which needs to be performed by an experienced team of interventional cardiologist, echocardiographer and anesthesiologist. To date available clinical results are promising showing low complication rates and high technical or clinical success rates of catheter-based closure of PVL (60-90%). Compared to surgical closure of PVL lower mortality rates (30-days mortality rate: 4,6%) have been documented in patients treated by catheter-based closure of PVL in clinical practice. Therefore interventional closure seems to be a promising option, which need to be discussed with every symptomatic patient suffering from PVL prior to therapeutical decision making. To date only sparse clinical data is available regarding indication and clinical outcome of patients undergoing catheter-based PVL in clinical practice. Therefore interventional closure of PVL should be limited to experienced interventional cardiologist at present. All patients treated should further be enrolled into a clinical registry to evaluate the safety and efficacy of catheter-based closure of PVL in clinical practice.

Fifteen-year experience with carotid artery stenting (from the carotid artery stenting-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte).

To date only sparse data are available on trends and changes in indications, patient's characteristics, and clinical outcome of patients undergoing carotid artery stenting (CAS) in clinical practice. From February 1996 to December 2010, 6,116 CAS procedures were performed in 5,976 patients at 36 hospitals within the prospective, multicenter CAS registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Median age of patients was 71 years, 71.6% were men; a symptomatic stenosis was treated in 50.3% and an embolic protection device (EPD) was used in 82.5% of the patients. The overall hospital mortality or stroke rate was 3.1%. Stroke or in-hospital death occurred in 4.0% in symptomatic patients and in 2.2% in asymptomatic patients. In a logistic regression model, independent predictors of in-hospital death or stroke were heart failure (odds ratio [OR] 2.03, 95% confidence interval [CI] 1.22 to 3.36, p = 0.006), symptomatic stenosis (OR 1.52, 95% CI 1.05 to 2.18, p = 0.03), and age (OR per 10 years 1.46, 95% CI 1.17 to 1.81, p <0.001). The use of an EPD was significantly associated with a lower rate of death or stroke in the registry (OR 0.45, 95% CI 0.26 to 0.78, p = 0.004). From 1996 to 2010, mean age of patients increased by 4.1 years (p <0.001), the proportion of male patients decreased from 82.4% to 70.2% (p = 0.07), the proportion of symptomatic stenoses decreased (84.6% to 24.7%, p <0.001), and the use of EPDs increased from 1.4% to 97.2% (p <0.001). Comparing 2 periods from 1996 to 2003 and 2004 to 2010, a numeric decrease in the in-hospital stroke or death rate was seen in symptomatic (4.7% vs 3.5%, p = 0.11), and in asymptomatic patients (2.9% vs 2.1%, p = 0.27) undergoing CAS, which did not reach statistical significance. In conclusion, the proportion of symptomatic carotid artery stenoses decreased significantly; EPDs established as a standard tool and a numeric decrease of in-hospital stroke or death was seen in asymptomatic and symptomatic patients undergoing CAS in clinical practice over the last 15 years.

Incidence and clinical impact of stroke complicating percutaneous coronary intervention: results of the Euro heart survey percutaneous coronary interventions registry.

BACKGROUND: Stroke is a rare but serious complication of percutaneous coronary interventions (PCIs). So far, scant information is available about the incidence and outcome of patients developing stroke after PCI for stable angina or acute coronary syndrome (ACS) in daily clinical practice in Europe today. METHODS AND RESULTS: Between 2005 and 2008, 46888 patients undergoing PCI were enrolled into the PCI Registry of the Euro Heart Survey Programme (176 centers in 33 European countries) to document patient's characteristics, PCI details, and hospital complications in different PCI indications. Stroke was observed in 0.4% of the procedures in the total population, in 0.3% of PCIs in elective patients, and in 0.6% in PCIs performed for ACS. The overall in-hospital mortality was 19.2% for patients who developed stroke (elective PCIs, 10.0%; PCI for ACS, 23.2%) compared with 1.3% for those without stroke (elective PCIs, 0.2%; PCI for ACS, 2.3%). In multivariate analysis hemodynamic instability, age ≥ 75 years, history of stroke, and congestive heart failure were found to be independent predictors for periprocedural stroke in ACS, whereas only PCI of a bypass graft and renal failure could be identified as independent predictors for stroke in elective patients. CONCLUSIONS: Stroke as complication of PCI occurs rarely (0.4%) in clinical practice in Europe today. However, peri-interventional stroke is still associated with an exceedingly high in-hospital mortality rate. Most predictors for periprocedural stroke are not modifiable and cannot be diminished before PCI. Therefore, treatment of patients with stroke after PCI needs further research.

Inhibition of neuropeptide degradation suppresses sweating but increases the area of the axon reflex flare.

The neuropeptides CGRP (calcitonin gene-elated peptide) and substance P (SP) mediate neurogenic inflammation. Both are degraded by the neutral endopeptidase (NEP) which can be blocked by phosphoramidon. The aim was to evaluate the effect of NEP inhibition on sweating and vasodilatation. Dermal microdialysis was performed on the skin of 39 subjects. Two fibres were perfused with phosphoramidon (0.01%, 0.02% or 0.2%), two with saline. Acetylcholine (ACh) was either added to the microdialysis perfusate (n = 30, 10(-2)  m) or thermoregulatory sweating was induced (n = 9). Co-application of phosphoramidon reduced cholinergic and thermoregulatory sweating. However, the flare size - a localized increase in superficial blood flow after ACh-application - was significantly increased. The increase in flare size is most probably due to increased CGRP levels. The inhibition of sweating by phosphoramidon may involve an increase in SP, a reduction in CGRP-degradation fragments or a direct inhibitory action of phosphoramidon.

Stroke in patients undergoing coronary angiography and percutaneous coronary intervention: incidence, predictors, outcome and therapeutic options.

In the present day, coronary angiography and percutaneous coronary intervention are considered to be safe procedures with low complication rates in general. Nevertheless due to their widespread use and their application in a continually aging population known to carry a higher risk for complications, periprocedural stroke affects thousands of patients undergoing coronary angiography and percutaneous coronary intervention worldwide every year. Stroke is reported to occur in 0.05-0.1% of diagnostic cardiac catheterizations and in 0.18-0.44% of patients treated with percutaneous coronary intervention in clinical routine today. Despite all improvements in pharmacological and technical issues, the rate of stroke after cardiac catheterization has remained almost constant over the last 20 years of invasive cardiology of invasive and interventional cardiology, which is most probably due to the immutability of the majority of risk factors before cardiac procedures. An advanced age, arterial hypertension, diabetes mellitus, coronary angiography performed under emergency conditions, history of stroke, renal failure, the use of an intra-aortic balloon pump, congestive heart failure and interventions at bypass grafts have been identified as risk factors for periprocedural stroke in large registries. Due to exceedingly high rates of mortality and disability stroke after coronary angiography still has an enormous impact on the patient's prognosis and on quality of life. If patients survive this devastating complication, most of them suffer from persistent neurological deficits such as motor or speech disorders. For its low incidence and consecutively missing data from randomized clinical trials, an evidence-based treatment could not yet be established, and treatment options are generally based on case series and small studies only. Nevertheless, intra-arterial thrombolysis and mechanical embolectomy seem to be promising and relatively safe approaches in the treatment of periprocedural ischemic stroke. Further research by randomized trials and large registries are needed to validate its efficacy and safety.

Carotid artery stenting in clinical practice: does sex matter? Results from the carotid artery stenting registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

BACKGROUND: Carotid artery stenting (CAS) is increasingly used for treatment of severe carotid artery stenosis, but only few procedural risk factors for complications of CAS are clearly defined yet. A possible impact of the patient's gender on the outcome of patients undergoing CAS has not been investigated properly and only little information about this topic is available so far. METHODS: We analysed data of the German prospective, multicenter CAS Registry of the Arbeitsgemeinschaft leitende kardiologische Krankenhausärzte. RESULTS: From July 1996 to May 2009 5130 patients underwent CAS at 35 German hospitals and were enrolled into the prospective ALKK CAS Registry. Therefrom 1443 (28.1%) patients were female. There was no significant time-related difference in the proportion of women undergoing CAS over the years. Women undergoing CAS were significantly older than men (73 years vs. 70 years, p < 0.01) and had a longer in hospital stay in comparison to men (p < 0.01). The majority of patients treated with CAS was between 60 and 80 years of age (∼73%). No significant differences between women and men could be found regarding in-hospital events like death (0.5% vs. 0.5%, p = 0.99), major or minor stroke (1.7% vs. 1.6%, p = 0.97; 1.0% vs. 1.6%, p = 0.12), TIA (2.8% vs. 2.6%, p = 0.64), amaurosis fugax (0.3% vs. 0.5%, p = 0.25) , intracranial bleeding (0.5% vs. 0.3%, p = 0.43), myocardial infarction (0.1% vs. 0.0%, p = 0.48) or all non-fatal strokes and all death (3.0% vs. 3.4%, p = 0.47). 30 day event rates did not show gender related differences in the combined endpoint of the outcome of patients undergoing CAS, as well (♀ n = 31/882 [3.5%] vs. ♂ n = 109/2273 [4.8%], p = 0.12). CONCLUSION: Our results do not suggest any gender-related differences in success rates and complications in CAS. In clinical practice approximately 30% of patients treated with CAS are women. The institutions and people who participated in the ALKK CAS Registry are listed in Zahn et al.16 The authors have no funding, financial relationships, or conflicts of interest to disclose.