Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses.

OBJECTIVES: We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses. METHODS: From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database. RESULTS: Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1-year follow-up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013. CONCLUSION: ViV-TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.

Validation of the HCM Risk-SCD model in patients with hypertrophic cardiomyopathy following alcohol septal ablation.

Aims: The HCM Risk-SCD model for prediction of sudden cardiac death (SCD) in hypertrophic cardiomyopathy recommended by the 2014 European Society of Cardiology (ESC) guidelines has not been validated after septal reduction therapy. The aim of this study was to validate the HCM Risk-SCD model in patients undergoing alcohol septal ablation (ASA) and to compare its performance to previous models. Methods and result: A total of 844 ASA patients without prior SCD event were included. The primary endpoint was a composite of SCD and appropriate implantable cardioverter defibrillator (ICD) therapy, identical to the HCM Risk-SCD endpoint. A distinction between periprocedural (≤30 days) and long-term (>30 days) SCD was made to discern procedure-related adverse arrhythmic events caused by the ASA-induced myocardial infarction from long-term SCD risk. Twenty patients reached the SCD endpoint within the first 30 days. During a follow-up of 6.5 ± 4.2 years, another 46 patients reached the SCD endpoint. The predicted 5-year SCD risk according to the HCM Risk-SCD model was 5.1%, and the observed 5-year SCD risk was 4.0%. The C-statistics for the use of the HCM Risk-SCD model was 0.61 (P = 0.02), the C-statistics for the use of the 2003 American College of Cardiology/ESC guidelines was 0.59 (P = 0.051), and the C-statistic for the use of the 2011 American College of Cardiology Foundation/American Heart Association guidelines was 0.58 (P = 0.054). Maximal left ventricular wall thickness, syncope after ASA, and fulfilling the 2014 ESC recommendations for primary ICD implantation according to the HCM Risk-SCD model, respectively, predicted SCD during long-term follow-up. Conclusion: The HCM Risk-SCD model can be used for SCD prediction in patients undergoing ASA.

Cycle length identifies obstructive sleep apnea and central sleep apnea in heart failure with reduced ejection fraction.

AIM: To clarify whether unmasking of central sleep apnea during continuous positive airway pressure (CPAP) initiation can be identified from initial diagnostic polysomnography (PSG) in patients with heart failure with reduced ejection fraction (HFREF) and obstructive sleep apnea (OSA) MATERIALS AND METHODS: Forty-three consecutive patients with obstructive sleep apnea and central sleep apnea (OSA/CSA) in HFREF were matched with 43 HFREF patients with OSA and successful CPAP initiation. Obstructive apneas during diagnostic PSG were then analyzed for cycle length (CL), ventilation length (VL), apnea length (AL), time to peak ventilation (TTPV), and circulatory delay (CD). We calculated duty ratio (DR) as the ratio of VL/CL and mathematic loop gain (LG). RESULTS: While AL was similar, CL, VL, TTPV, CD, and DR was significantly longer in patients with OSA/CSA compared to those with OSA, and LG was significantly higher. Receiver operator curves identified optimal cutoff values of 50.2 s for CL (area under the curve (AUC) 0.85, 29.2 s for VL (AUC 0.92), 11.5 s for TTPV (AUC 0.82), 26.4 s for CD (AUC 0.79), and 3.96 (AUC 0.78)) respectively for LG to identify OSA/CSA. CONCLUSION: OSA/CSA in HFREF can be identified by longer CL, VL, TTPV, and CD from obstructive events in initial diagnostic PSG. The underlying mechanisms seem to be the presence of an increased LG.

Physiological left ventricular segmental myocardial mechanics: Multiparametric polar mapping to determine intraventricular gradients of myocardial dynamics.

OBJECTIVE: We investigated physiological systolic left ventricular (LV) myocardial mechanics and gradients to provide a database for later studies of diseased hearts. METHODS: The analyses were performed in 131 heart-healthy individuals and included seven parameters of myocardial mechanics using speckle tracking echocardiography (STE). RESULTS: Basal to apical and circumferentially significant physiological intraventricular parameter gradients of myocardial activity were determined. Global mean values and segmental ranges were peak systolic longitudinal strain -21.2 ± 3.3%, 95% confidence interval [CI] -21.8% to -20.6%), gradient (basal to apical) -16.0% to -26.7%; peak systolic longitudinal strain rate -1.24 ± 0.31%/s, 95% CI -1.29% to -1.19%/s, gradient (basal to apical) -0.91% to -1.61%/s; post-systolic index 2.6 ± 3.2%, 95% CI 3.15%-2.05%, gradient (basal/medial/apical) 7.0/1.2/2.4%; pre-systolic stretch index 1.3 ± 2.7%, 95% CI 1.77%-0.83%, gradient (basal/medial/apical) 6.5/0.2/1.3%; peak longitudinal displacement 12.2 ± 2.6 mm, 95% CI 12.6-11.8 mm, gradient (basal to apical) 21.0-3.4 mm; time-to-peak longitudinal strain 370 ± 43 ms, 95% CI 377-363 ms, gradient (basal to apical) 396-361 ms; and time-to-peak longitudinal strain rate 180 ± 47 ms, 95% CI 188-172 ms, gradient (basal to apical) 150-200 ms. CONCLUSION: This study generated a database of seven STE-derived parameters of physiological segmental and global myocardial LV mechanics. The resulting sets of three-dimensional intraventricular mappings of the entire LV provide physiological parameter gradients in baso-apical and circumferential direction by applying the 17-segment polar model. This will facilitate comparison of systolic myocardial activity of the healthy LV with diseased or otherwise altered (eg, sports) hearts.

Impact of procedure-related conduction disturbances after transcatheter aortic valve implantation on myocardial performance and survival evaluated by conventional and speckle tracking echocardiography.

OBJECTIVES: Although procedure-related new cardiac conduction disturbances (CCDs) remain an important issue in transcatheter aortic valve implantation (TAVI), their effect on myocardial function and overall patient outcome remains unclear. The goal of this study was to analyze the influence of procedure-related CCDs on systolic and diastolic LV performance and on patient survival after TAVI. METHODS AND RESULTS: Ninety-five patients who underwent TAVI for severe symptomatic aortic stenosis (AS) and had a complete follow-up were evaluated with respect to procedure-related CCDs. Left ventricular (LV) performance was measured using standard echocardiographic parameters and speckle tracking analysis. Survival was assessed during longer-term follow-up (mean: 29.1 ± 16.9 months). After TAVI, the improvement of global LV function expressed as ejection fraction (LVEF; from 45.5 ± 10.0 to 47.8 ± 13.9%, P = .13) was not significant. New CCDs were found in 35.7% of TAVI recipients. A comparison between patients with and without new CCDs showed that LV systolic function improved in those without CCDs, while it tended to deteriorate in patients with CCDs (change in LVEF: 5.5 ± 12.3% vs -4.9% ± 11.5%, P = .001; change in global longitudinal strain (GLS): -1.1 ± 4.6% vs 1.2 ± 4.5%, P = .01). Changes in diastolic function did not differ significantly between the groups (changes in transmitral E/A-ratio: -0.3 ± 0.6 vs -0.5 ± 0.5, P = .1). Kaplan-Meier survival analysis revealed no significant differences between the two cohorts (P = .795). CONCLUSION: Procedure-related conduction abnormalities after TAVI lead to an LBBB-related dyssynchrony with impairment of LV performance but not of overall survival.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

BACKGROUND: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. METHODS: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001). RESULTS: There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). CONCLUSION: Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.

Impact of sleep-disordered breathing in patients with acute myocardial infarction: a retrospective analysis.

Sleep-disordered breathing (SDB) is associated with an increased risk of cardiovascular events. Previous studies showed that severe SDB has a negative impact on myocardial salvage and progression of left ventricular dysfunction after acute myocardial infarction (AMI). This study investigated the frequency of SDB and the effects of SDB on left ventricular function after AMI. This retrospective study enrolled all patients with AMI who had undergone cardiorespiratory polygraphy for SDB diagnosis. The apnea-hypopnea index was used as a standard metric of SDB severity. SDB was classified as mild (apnea-hypopnea index >5 to <15 per h), moderate (≥15 to <30 per h) or severe (apnea-hypopnea index ≥30 per h). According to the majority of events, SDB was classified as predominant obstructive sleep apnea, central sleep apnea or mixed sleep apnea (mixed SDB). A total of 223 patients with AMI (112 with ST elevation and 111 without ST elevation; 63.2 ± 11.2 years, 82% male, left ventricular ejection fraction 49 ± 12%) were enrolled. SDB was present in 85.6%, and was moderate-to-severe in 63.2%; 40.8% had obstructive sleep apnea, 41.7% had central sleep apnea and 3.1% had mixed SDB. Left ventricular ejection fraction was lower in patients with AMI with severe SDB (45 ± 14%) versus those without SDB (57 ± 7%; P < 0.005). In addition, lower left ventricular ejection fraction (≤45%) was associated with increased frequency (apnea-hypopnea index ≥5 per h in 96%) and severity (apnea-hypopnea index ≥30 per h in 48%) of SDB in general and a higher percentage of central sleep apnea (57%) in particular. SDB is highly frequent in patients with AMI. SDB severity appeared to be linked to impaired left ventricular function, especially in patients with central sleep apnea.

Reduction of radiation exposure in cryoballoon ablation procedures: a single-centre study applying intracardiac echocardiography and other radioprotective measures.

AIMS: The population treated with cryoballoon (CB) ablation is relatively young, and radiation protection is of major importance. We aimed to demonstrate that radiation exposure can be markedly reduced by intracardiac echocardiography (ICE) and optimized settings of the X-ray system. METHODS AND RESULTS: We analysed 100 patients undergoing CB pulmonary vein isolation (PVI) for treatment of paroxysmal atrial fibrillation. In 50 consecutive patients (25 male, 59 ± 13 years; Group 1), we used ICE, skipped PV angiography prior to CB inflation, and avoided fluoroscopy whenever possible. Furthermore, we reduced the frame rate, minimized distance between patient and detector, and consequently applied collimation. These patients were compared with 50 similar preceding patients in Group 2 (29 male, 61 ± 12 years). Total fluoroscopy time was reduced from 18 ± 6 min in Group 2 to 12 ± 5 min in Group 1 (P < 0.001). Moreover, the dose area product was significantly lower (1555 ± 1219 vs. 4935 ± 2094 cGycm2, P < 0.001), total freezing time was significantly shortened (1855 ± 399 vs. 2121 ± 756 s, P = 0.031), and contrast media use was significantly reduced (66 ± 25 vs. 109 ± 27 mL, P < 0.001). At the same time, total procedure duration and complication rates did not differ significantly between both groups. After a 12 months follow-up, a similar percentage of patients was free from recurrences (74% in Group 1 vs. 78% in Group 2, P = 0.640). CONCLUSION: Radiation exposure in CB PVI can be markedly reduced without prolonging procedure times, affecting the outcome or complication rates. Moreover, ICE seems to shorten total freezing time.

Resolution of Cheyne-Stokes Respiration after Treatment of Heart Failure with Sacubitril/Valsartan: A First Case Report.

Sleep-disordered breathing (SDB) is highly prevalent in patients with heart failure (HF), and is known to be associated with a worse prognosis. The severity of central sleep apnea is thought to mirror cardiac dysfunction. The novel angiotensin receptor-neprilysin inhibitor (ARNi) sacubitril has been shown to improve HF, but a relationship between treatment with ARNi and the severity of SDB has not yet been investigated. We report the case of a 71-year-old male with HF and SDB. Treatment with sacubitril/valsartan was associated with improved cardiac function, as shown by a reduction in the level of N-terminal prohormone of brain natriuretic peptide from 3,249 to 1,720 pg/mL, and an improvement in left-ventricular ejection fraction from 30 to 35%. This was accompanied by a marked reduction in the apnea-hypopnea index (from 41 to 19/h). To the best of our knowledge, this is the first case to document parallel improvements in HF and SDB after the initiation of ARNi treatment.

Long-Term Experience with First-Generation Implantable Neurostimulation Device in Central Sleep Apnea Treatment.

BACKGROUND: Sleep-disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) are associated with shorter survival in patients with heart failure. A novel treatment method for this patient group is unilateral phrenic nerve stimulation by the remede® system (Respicardia Inc., Minnetonka, MN, USA), a transvenously implantable neurostimulation device, which has recently been studied in a large randomized, controlled trial. Previous literature has shown efficacy and safety of the treatment with this first-generation device, but hardly any data are available on long-term clinical parameters, the remede® device's battery lifetime, device exchangeability, lead position stability, surgical accessibility, and manageability. METHODS: We performed remede® device replacements in consecutive patients for battery depletion, and documented clinical parameters, longevity, operation procedure, complications, and difficulties. RESULTS: All patients were on neurostimulation treatment by phrenic nerve neurostimulation when device replacement became necessary. Apnea-hypopnea index (from 45 ± 4/h to 9 ± 4/h), oxygen-desaturation index (from 35 ± 7/h to 7 ± 6/h), and time spent with oxygen saturation of <90% (T < 90% from 5 ± 7% to 0 ± 0%) were improved and improvements remained constant throughout the 4-year follow-up. Mean battery life was 4.2 ± 0.2 years and mean replacement procedure time was 25 ± 5.1 minutes. Apart from conventional X-ray documentation of stable lead positions in a long-term setting, no radiation or contrast dye usage was needed and no major complications occurred. In addition, clinical exercise capacity and sleepiness symptoms improved. CONCLUSIONS: Novel remede® device shows sustained therapy efficacy and safety in terms of stable lead positions over 4 years. Long-term phrenic nerve neurostimulation therapy for central SDB/CSR appears feasible in a clinical routine setting.

Sleep duration and quality in heart failure patients.

PURPOSE: Sleep-disordered breathing (SDB) is highly prevalent in patients with heart failure and reduced left ventricular ejection fraction (HF-REF). SDB is classified as predominant obstructive (OSA) or central (CSA) and may alter sleep duration, sleep quality, and quality of life. This study describes sleep quality and duration in well-characterized cohorts of these patients. METHODS: Two hundred fifty consecutive patients with HF-REF (NYHA class ≥II, ejection fraction ≤45%) underwent cardiac and pulmonary examination, plus full attended in-hospital overnight polysomnography (PSG). PSG recordings were performed according to current recommendations and underwent independent, blinded analysis at a core laboratory. RESULTS: Patients with HF-REF and CSA were older and had more impaired cardiac function compared to those with OSA. With respect to sleep parameters, patients with CSA spent more time in bed than those with OSA (468 ± 52 vs 454 ± 46 min, p = 0.021) while sleep efficiency was lower (67 ± 14 vs 72 ± 13% of total sleep time (TST), p = 0.008). In addition, CSA patients spent more time awake after sleep onset (101 ± 61 vs 71 ± 46 min, p = 0.001) and had more stage N1 (light) sleep (33 ± 19 vs 28 ± 16% of TST, p = 0.017). Overall, the proportion of sleep spent in N3 (slow-wave/deep) sleep in HF-REF patients with SDB was low (4.1 ± 6.3% of TST) compared with healthy adults. CONCLUSIONS: HF-REF patients with CSA compared to OSA have worse sleep efficiency and quality. This could result in less restorative sleep, changes in sympathovagal balance, and impaired resetting of important reflexes, which might contribute to worse cardiovascular outcomes in HF-REF patients with SDB.

Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients.

AIM: This study investigated the prognostic value of sleep-disordered breathing (SDB) in a large cohort of patients with heart failure with reduced left ventricular function (HF-REF), with focus on the role of nocturnal hypoxaemia. METHODS: This single-centre prospective cohort study enrolled patients with chronic stable HF-REF (NYHA ≥II) receiving guideline-based treatment. Unattended in-hospital polygraphy was performed to determine the apnoea-hypopnoea index (AHI). Pulse oximetry was used to determine hypoxaemic burden [time with oxygen saturation <90% (T90)], and all-cause mortality was recorded. RESULTS: Complete data were available for 963 of 1249 patients. At baseline, 58% of patients had moderate-to-severe SDB. The median follow-up was 7.35 years; 480 of 963 (49.8%) patients died. Mortality rate (per 100 person-years) was 8.1 [95% confidence interval (CI) 7.0-9.4] in patients with no or mild SDB, but 12.2 (95% CI 10.9-13.7) in moderate-to-severe SDB. Apnoea-hypopnoea index was significantly associated with time to death from any cause in a simple Cox model [hazard ratio (HR) 1.011, P < 0.001], but was no longer significant after adjustment for confounding factors (HR 1.005, P = 0.085). T90 was significantly (P < 0.001) associated with time to death from any cause even after adjustment for confounding factors. The risk of death increased by 16.1% (95% CI 8.6-24.2) per hour of T90. Five-year survival probabilities for patients in T90 quartiles 1, 2, 3, and 4 were 70, 63, 60, and 50%, respectively. CONCLUSION: Hypoxaemic burden was a robust and independent predictor of all-cause mortality in chronic stable HF-REF patients. Whether or not targeting nocturnal hypoxaemia is associated with beneficial effects on mortality in HF-REF patients remains to be determined.

Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: results from the Euro-ASA registry.

AIMS: The first cases of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) were published two decades ago. Although the outcomes of single-centre and national ASA registries have been published, the long-term survival and clinical outcome of the procedure are still debated. METHODS AND RESULTS: We report long-term outcomes from the as yet largest multinational ASA registry (the Euro-ASA registry). A total of 1275 (58 ± 14 years, median follow-up 5.7 years) highly symptomatic patients treated with ASA were included. The 30-day post-ASA mortality was 1%. Overall, 171 (13%) patients died during follow-up, corresponding to a post-ASA all-cause mortality rate of 2.42 deaths per 100 patient-years. Survival rates at 1, 5, and 10 years after ASA were 98% (95% CI 96-98%), 89% (95% CI 87-91%), and 77% (95% CI 73-80%), respectively. In multivariable analysis, independent predictors of all-cause mortality were age at ASA (P < 0.01), septum thickness before ASA (P < 0.01), NYHA class before ASA (P = 0.047), and the left ventricular (LV) outflow tract gradient at the last clinical check-up (P = 0.048). Alcohol septal ablation reduced the LV outflow tract gradient from 67 ± 36 to 16 ± 21 mmHg (P < 0.01) and NYHA class from 2.9 ± 0.5 to 1.6 ± 0.7 (P < 0.01). At the last check-up, 89% of patients reported dyspnoea of NYHA class ≤2, which was independently associated with LV outflow tract gradient (P < 0.01). CONCLUSIONS: The Euro-ASA registry demonstrated low peri-procedural and long-term mortality after ASA. This intervention provided durable relief of symptoms and a reduction of LV outflow tract obstruction in selected and highly symptomatic patients with obstructive HCM. As the post-procedural obstruction seems to be associated with both worse functional status and prognosis, optimal therapy should be focused on the elimination of LV outflow tract gradient.

Echocardiographically derived effective valve opening area in mitral prostheses: a comparative analysis of various calculations using continuity equation and pressure half time method.

Detection of dysfunctional mitral valve prostheses (MP) remains complex even though being optimized by considering echocardiographically derived prosthetic effective orifice area (VA). The purpose was to compare VA in MP, calculated by the continuity equation (CE) using peak velocities (CEVpeak), mean velocities (CEVmean), velocity-time integrals (CEVTI) and the pressure half time method using 220 ms as constant first (PHT220) as well as optimized constants. In 267 consecutive patients with normally functioning MP, we investigated VA within the first postoperative month. With increasing prosthetic sizes, mean VA values also increase in all calculations. The statistical curves demonstrate no significant difference in graphical steepness but show different levels. Comparison of mean VA showed the known systematic higher values of PHT220 and significantly decreased results when using CEVTI. This systematic difference between mean VA applying PHT220 versus CEVTI is approximately 1.0 cm(2) for all prosthetic sizes. Calculations via CEVpeak were close to the results of CEVTI. CEVmean produced values, which graphically correspond to the PHT220 curve. Only PHT220 detected the constructional equal prosthetic inner ring width between 29 and 31 mm. To compensate the systematic difference between CEVTI and PHT220, an optimized constant of 140 ms was calculated to be applied in PHT (PHT140). VA is a robust and, therefore, preferable parameter for investigating MP. If needed, both CE and PHT are applicable with a systematical difference between CEVTI and PHT220. An optimized constant of 140 ms (PHT140) should be applied when calculating VA of mitral valve prostheses via PHT.

Heterogenous haemodynamic effects of adaptive servoventilation therapy in sleeping patients with heart failure and Cheyne-Stokes respiration compared to healthy volunteers.

This study investigated the haemodynamic effects of adaptive servoventilation (ASV) in heart failure (HF) patients with Cheyne-Stokes respiration (CSR) versus healthy controls. Twenty-seven HF patients with CSR and 15 volunteers were ventilated for 1 h using a new ASV device (PaceWave™). Haemodynamics were continuously and non-invasively recorded at baseline, during ASV and after ventilation. Prior to the actual study, a small validation study was performed to validate non-invasive measurement of Stroke volume index (SVI). Non-invasive measurement of SVI showed a marginal overall difference of -0.03 ± 0.41 L/min/m(2) compared to the current gold standard (Thermodilution-based measurement). Stroke volume index (SVI) increased during ASV in HF patients (29.7 ± 5 to 30.4 ± 6 to 28.7 ± 5 mL/m(2), p < 0.05) and decreased slightly in volunteers (50.7 ± 12 to 48.6 ± 11 to 47.9 ± 12 mL/m(2)). Simultaneously, 1 h of ASV was associated with a trend towards an increase in parasympathetic nervous activity (PNA) in HF patients and a trend towards an increase in sympathetic nervous activity (SNA) in healthy volunteers. Blood pressure (BP) and total peripheral resistance response increased significantly in both groups, despite marked inter-individual variation. Effects were independent of vigilance. Predictors of increased SVI during ASV in HF patients included preserved right ventricular function, normal resting BP, non-ischaemic HF aetiology, mitral regurgitation and increased left ventricular filling pressures. This study confirms favourable haemodynamic effects of ASV in HF patients with CSR presenting with mitral regurgitation and/or increased left ventricular filling pressures, but also identified a number of new predictors. This might be mediated by a shift towards more parasympathetic nervous activity in those patients.

Acute improvement of pulmonary hemodynamics does not alleviate Cheyne-Stokes respiration in chronic heart failure-a randomized, controlled, double-blind, crossover trial.

OBJECTIVES: This randomized, controlled trial aimed to investigate whether acute improvement of pulmonary congestion would reduce the severity of Cheyne-Stokes respiration (CSR) in patients with chronic heart failure (CHF). METHODS: Twenty-one consecutive patients with CHF and CSR (apnea-hypopnea index [AHI] ≥15/h) underwent right heart catheterization with titration of intravenous (IV) glyceryltrinitrate (GTN) to a maximum tolerable dosage and inhalation of iloprost 10 µg/mL after a washout phase. Maximum tolerable dosages of GTN and iloprost were randomly applied during full cardiorespiratory polysomnography within two split-night procedures and compared with IV or inhaled sodium chloride (NaCl) 0.9 %, respectively. RESULTS: GTN (6.2 ± 1.5 mg/h) and iloprost significantly lowered \mean pulmonary artery pressure (20.1 ± 9.0 to 11.6 ± 4.2 mmHg, p < 0.001 and 16.9 ± 7.9 to 14.2 ± 6.4 mmHg, p < 0.01, respectively). Pulmonary capillary wedge pressure was only reduced by GTN (14.0 ± 5.6 to 7.2 ± 3.9 mmHg, p < 0.001), and there was no significant change in the cardiac index. Sleep studies revealed no significant improvement in markers of CSR severity, including AHI, central apnea index, and CSR cycle length following GTN or iloprost treatment. Significant decreases in blood pressure, mean oxygen saturation, and S3 sleep were documented during GTN infusion. CONCLUSIONS: Acute improvement of pulmonary congestion by GTN had no immediate impact on CSR severity. Future investigations must therefore include longer treatment periods and treatment regimens that have positive, rather than negative, additional effects on peripheral and central chemoreceptors and sleep structure. TRIAL REGISTRATION: German Clinical Trial Registry-ID:DRKS00000467 ( www.germanctr.de ).

First Explantation of Direct Flow Medical Transcatheter Valve.

Next-generation transcatheter heart valves are designed to overcome procedure-related adverse events such as vascular complications and annulus rupture, and to minimize paravalvular regurgitation. The Direct Flow Medical valve is fully repositionable and shows promising results. The case is presented of Direct Flow Medical valve implantation in a patient with a functional bicuspid aortic valve. Multiple repositioning maneuvers failed to overcome the anatomic difficulties, and this resulted in a moderately high persisting gradient and moderate paravalvular leakage. Surgical valve explantation was necessary which, to the present authors' knowledge, is the first such case of Direct Flow Medical valve explantation to be performed.

A differentiated morphological parameter-coding system to describe the suitability of mitral valve stenoses intended for percutaneous valvotomy.

Percutaneous balloon-mitral-valvotomy (PBMV) is an alternative to surgery in selected patients with mitral valve (MV) stenosis (MS). Applying echocardiography, suitability for PBMV is assessed by detailed morphological description. Echo-scores alone are suboptimal to describe MV morphology, because single parameters, important for a decision concerning PBMV, are not distinguishable out of a score number. The aim was to design a tool (coding-system), which combines a number for a stenotic MV like scores (for statistical options) and decodable, generally applied parameters describing the MS morphology. The reproducibility of the MS morphology using the coding-system has to be tested in 90 patients. A separate group of 297 patients (pts) with MS, scheduled for PBMV, should be investigated prospectively applying the coding-system and a comparable score. We chose the Wilkins score (WS) as representative of scores. The coding-system is designed as a parameter sequencing set consisting of 6 digits. The first digit indicates a decision code concerning suitability for PBMV. The following 5 digits indicate generally accepted morphological parameters, which are partially also used in the WS. Therefore, the MS morphology can be "read" retrospectively by decoding. 201/297 patients were found suitable for PBMV. Applying the coding-system all 201 suitable patients were correctly distinguished from 96 morphologically unsuitable patients. Astonishingly 48/96 of the rejected patients showed a WS ≤8 whereas 28/201 of the suitable patients demonstrated a WS >8. 25/28 of them showed a successful initial outcome. Applying the generally known threshold of "8" when predicting suitability of a MS, the WS demonstrated an initial success rate of 62 %, sensitivity of 0.87, specificity of 0.45, precision of 0.79, and accuracy of 0.78. Applying the coding-system, the initial success rate was 70.8 %, sensitivity = 0.96, specificity = 1.0, precision = 1.0, and accuracy = 0.97. The coding-system is an advanced diagnostic aid, is statistically applicable, offers a decodable morphological description, includes a decision code regarding suitability for PBMV, and can be used for comparing different groups of patients with MS by calculating "mean morphologies" of groups.

Respiratory effects of adaptive servoventilation therapy in patients with heart failure and Cheyne-Stokes respiration compared to healthy volunteers.

BACKGROUND: Nocturnal adaptive servoventilation (ASV) therapy is now frequently used to treat Cheyne-Stokes respiration (CSR), which is highly prevalent in patients with moderate-to-severe heart failure (HF) and characterized by periodical breathing (hyperventilation). OBJECTIVES: This study analyzed and compared the acute effects of a novel ASV device on carbon dioxide pressure (pCO2) and oxygen saturation (SaO2) in HF patients with CSR and healthy volunteers. The influence of being asleep or awake on the ASV algorithm was also determined. METHODS: All subjects underwent ASV (PaceWave™, ResMed) for 1 h. Transcutaneous pCO2 (PtcCO2) and SaO2 were assessed transcutaneously, while wakefulness was analyzed using EEG recordings. Assessments were made 30 min before and after ASV, and during 1 h of ASV. RESULTS: Twenty HF patients (19 male; age 79 ± 12 years) and 15 volunteers (13 male, age 25 ± 4 years) were included. When awake, ASV was associated with a trend towards a decrease in PtcCO2 and an increase in SaO2 versus baseline in HF patients (34.4 ± 3.2 to 33.7 ± 3.8 mm Hg and 93.8 ± 2.6 to 94.9 ± 2.6%, respectively) and volunteers (39.5 ± 3.0 to 38.2 ± 3.8 mm Hg and 96.9 ± 1.3 to 97.8 ± 0.9%). While asleep during ASV, PtcCO2 increased to 36.3 ± 3.8 mm Hg and SaO2 decreased to 93.8 ± 2.6% in HF patients, with similar changes in volunteers (PtcCO2 41.7 ± 3.0 mm Hg, SaO2 97.1 ± 1.2). All comparisons were statistically significant (p ≤ 0.05, except the PtcCO2 decrease in both groups when awake). CONCLUSIONS: ASV therapy might result in hyperventilation when subjects are awake, but while asleep, PtcCO2 increased to mid-normal values, effects that would be favorable in HF patients with CSR.

Performance of conventional and enhanced adaptive servoventilation (ASV) in heart failure patients with central sleep apnea who have adapted to conventional ASV.

PURPOSE: Adaptive servo-ventilation (ASV) is a positive pressure ventilator support system to normalize ventilation in patients with Cheyne-Stokes respiration (CSR). The latest generation enhanced ASV device (PaceWave; ResMed) has a new feature--auto-adjustment of EPAP. This study tested the hypothesis that enhanced ASV with auto-adjustment of EPAP (PaceWave) is non-inferior to conventional ASV (AutoSetCS). METHODS: This prospective, randomized, crossover, single-center study enrolled adult patients with stable heart failure (HF) and moderate-to-severe sleep-disordered breathing (SDB) who had been receiving conventional ASV therapy for at least 4 weeks. Patients received conventional ASV for one night and enhanced ASV on another night. Support settings for the two ASV devices were similar, with fixed expiratory positive airway pressure (EPAP) set to between 4 and 10 cm H2O and variable EPAP set to between 4 and 15 cm H2O. Full polysomnography was performed during ASV therapy on both nights. Endpoints were the number of nocturnal respiratory events and oxygen desaturations, and changes in blood pressure (BP). RESULTS: Levels of EPAP were comparable during the use of enhanced and conventional ASV, but minimum and maximum inspiratory pressure support values were significantly higher with the PaceWave device. All measures of apnea and hypopnea, and oxygen saturation, were significantly improved during ASV therapy with either device. There were no significant changes in BP or heart rate. CONCLUSIONS: Enhanced ASV is non-inferior to ASV with fixed EPAP in patients with chronic HF and CSR, with a trend towards better control of respiratory events.