A retrospective analysis of frailty status on atrial fibrillation catheter ablation outcomes.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) reduces symptoms and improves the quality of life compared with medical treatment. It is unclear if frailty impacts on the outcome of catheter ablation in patients with symptomatic AF. We sought to evaluate the association between frailty as measured by the validated NHS electronic Frailty Index (eFI) and outcomes post-AF ablation. METHODS: Two hundred forty eight patients who had undergone AF ablation with a mean age of 72.9 ± 5.16 were included in the study retrospectively. The primary endpoint for success was defined as freedom from atrial arrhythmia lasting >30 s beyond the 3-month blanking periods. Frailty was based on the eFI, and the cohort split into four groups: fit (no frailty), mild, moderate and severe frailty. RESULTS: Frailty was categorized as fit (118/248; 47.6%), mild (66/248; 26.6%), moderate (54/248; 21.8%), and severe (10/248; 4.0%). Freedom from arrhythmia occurred in 167 of 248 (67.3%) patients after a mean follow-up of 25.8 +/- 17.3 months. Fit patients had significantly greater freedom from arrhythmia (92/118; 78%) compared to mild frailty (40/66; 60.6%, p-value = .020), moderate frailty (31/54; 57.4%, p-value = .006), or severe frailty (4/10; 40.0%, p-value < .001). There was also a significant difference in arrhythmia occurrence between patients with mild frailty and severe frailty (p-value = .044). CONCLUSION: Frailty is associated with poorer outcomes in patients undergoing AF ablation. The eFI may be used in the prognostic evaluation of AF ablation outcomes. Further studies are essential to confirm the findings of this study.

A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale.

INTRODUCTION: Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS: The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS: Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION: This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden.

A randomized comparison of retrograde left-sided versus anterograde right-sided ablation of the atrioventricular junction.

BACKGROUND: Catheter ablation of the atrioventricular node (AVN) is an effective treatment for patients with symptomatic atrial fibrillation. This study compares the success rate, procedure time, radiation time, and complication rates of retrograde left-sided (LSA) and anterograde right-sided (RSA) AVN ablation in a randomised controlled trial. METHODS: Thirty-one patients undergoing AVN ablation were randomized to either LSA (15 patients) or RSA (16 patients). Crossover occurred after six unsuccessful radiofrequency (RF) applications. RESULTS: The LSA cohort had a mean age of 77.00 ± 5.17 and the RSA cohort was 79.44 ± 6.08 (p = .0240). There were five crossovers from LSA to RSA and there was one crossover from RSA to LSA. There was no significant difference in ablation time between LSA and RSA (210.40 ± 179.77 vs. 192.19 ± 130.29 seconds, p = .748). There was no significant difference in procedure time, fluoroscopy time, radiation dose, or number of RF applications between the two groups. There was 1 (6.67%) serious adverse event in the LSA group and 1 (6.25%) in the RSA group due to femoral hematomas requiring blood transfusion or intervention. There was no significant difference in patient-reported discomfort between LSA and RSA (16.43 ± 20.67 vs. 17.87 ± 28.08, p = .877). The study was stopped before full recruitment due to futility. CONCLUSIONS: Retrograde LSA of the AVN does not reduce RF applications, procedure time, or radiation exposure compared with conventional RSA and cannot be recommended as a first-line clinical approach.

The long-term effect of thermal-guided second-generation cryoablation in paroxysmal and persistent atrial fibrillation.

BACKGROUND: Second-generation cryoballoon ablation is safe and effective in patients with paroxysmal (PAF) and persistent atrial fibrillation (AF). OBJECTIVE: This study aimed to assess the long-term clinical outcomes and freedom from AF in patients undergoing thermal-guided cryoablation without the use of an electrical mapping catheter. METHODS: All patients who had undergone thermal-guided second-generation cryoablation without electrical mapping between January 2015 and April 2018 at Eastbourne District General Hospital were retrospectively analysed. Success was defined as freedom from atrial arrhythmia lasting >30 s during the follow up period. RESULTS: The study included 234 patients with a mean age of 65.3 ± 10.6 years. There were 134 (57.0%) and 100 (42.7%) patients who had PAF and persistent AF respectively. Arrhythmia recurrence occurred in 38 of 134 (28.4%) PAF and 42 of 100 (42.0%) persistent AF patients after mean follow up of 40 ± 9.2 months. The patients with PAF had a significantly greater freedom from arrhythmia than patients with persistent AF (p = .040). The mean procedure time was 55.5 ± 12.2 min and the mean fluoroscopy time was 10.9 ± 4.8 min 73.5% of patients were discharged on the same day. CONCLUSION: Thermal-guided cryoablation is feasible, safe and results in freedom from arrhythmia in the majority of paroxysmal and persistent AF patients in the long term. Randomised controlled trials are required to confirm the findings of this study.

Long Term outcomes of percutaneous atrial fibrillation ablation in patients with continuous monitoring.

INTRODUCTION: There is limited data using continuous monitoring to assess outcomes of atrial fibrillation (AF) ablation. This study assessed long-term outcomes of AF ablation in patients with implantable cardiac devices. METHODS: 207 patients (mean age 68.1 ± 9.5, 50.3% men) undergoing ablation for symptomatic AF were followed up for a mean period of 924.5 ± 636.7 days. Techniques included The Pulmonary Vein Ablation Catheter (PVAC) (59.4%), cryoablation (17.4%), point by point (14.0%) and The Novel Irrigated Multipolar Radiofrequency Ablation Catheter (nMARQ) (9.2%). RESULTS: 130 (62.8%) patients had paroxysmal AF (PAF) and 77 (37.2%) persistent AF. First ablation and repeat ablation reduced AF burden significantly (relative risk 0.91, [95% CI 0.89 to 0.94]; P <0.0001 and 0.90, [95% CI, 0.86-0.94]; P <0.0001). Median AF burden in PAF patients reduced from 1.05% (interquartile range [IQR], 0.1%-8.70%) to 0.10% ([IQR], 0%-2.28%) at one year and this was maintained out to four-years. Persistent AF burden reduced from 99.9% ([IQR], 51.53%-100%) to 0.30% ([IQR], 0%-77.25%) at one year increasing to 87.3% ([IQR], 4.25%-100%) after four years. If a second ablation was required, point-by-point ablation achieved greater reduction in AF burden (relative risk, 0.77 [95% CI, 0.65-0.91]; P <0.01). CONCLUSION: Ablation reduces AF burden both acutely and in the long-term. If a second ablation was required the point-by-point technique achieved greater reductions in AF burden than "single-shot" technologies. Persistent AF burden increased to near pre ablation levels by year 4 suggesting a different mechanism from PAF patients where this increase did not occur.

The effect of second-generation cryoablation without electrical mapping in persistent AF using continuous monitoring.

BACKGROUND: Second-generation cryoballoon ablation is safe and effective in patients with persistent atrial fibrillation (AF). The aim of this study is to report the real long-term AF burden and freedom from AF post-cryoablation using continuous monitoring, and to assess whether intraoperative confirmation of pulmonary vein isolation using electrical mapping is necessary. METHODS: A total of 33 patients (mean age 75.7 ± 5.6 years, 16 men) with persistent AF who underwent second-generation cryoablation without electrical mapping were reviewed. All patients had a cardiac implantable device and were followed up for a mean of 755 ± 170 days. RESULTS: AF burden significantly decreased from 67.51% ± 34.90% to 18.28% ± 26.65% at 1-year follow-up, and this reduction was maintained at final follow-up (18.26% ± 23.70%, p < 0.001). Continuous monitoring revealed a freedom from AF rate of 33% and 24% at 1-year and full follow-up, respectively. Patients who remained in persistent AF at final follow-up had a trend towards higher pre-ablation AF burden (81.6% ± 29.7% vs 57.3% ± 36.4%, p = 0.08). CONCLUSION: Second-generation cryoablation without confirming pulmonary vein isolation using electrical mapping is effective leading to significant reductions in AF burden based on continuous beat-to-beat monitoring at 1-year and long-term follow-up.

How many patients with heart failure are eligible for cardiac contractility modulation therapy?

BACKGROUND: Increasing evidence exists suggesting that cardiac contractility modulation therapy (CCM) improves symptoms in heart failure patients if various selection criteria are fulfilled. The aim of this study is to analyse an unselected sample of heart failure patients to establish what percentage of patients would meet the current criteria for CCM therapy. METHODS: All patients admitted to two district general hospitals in the UK in 2018 with a diagnosis of heart failure were audited for eligibility for CCM therapy. The selection criteria were (a) ejection fraction (EF) 25%-45%, (b) QRS duration less than 130 ms, (c) New York Heart Association (NYHA) class 3-4 and (d) treated for heart failure for at least 90 days and on stable medications. Exclusion criteria included: (a) significant valvular disease, (b) permanent or persistent atrial fibrillation, (c) biventricular pacing system implanted or QRS duration more than 130 ms and (4) patients not suitable for device therapy as a result of palliative treatment intent. RESULTS: A total of 475 patients were admitted with heart failure during the study period. From this group, 24 (5.1%) patients fulfilled the criteria for CCM therapy. The mean age and ejection fraction were 70.8 ± 10.2 and 32.5% ± 7.4%. The majority of patients were men (71%) and had an ischaemic cardiomyopathy (75%). If patients with atrial fibrillation were included, an additional 18 (3.8%) patients potentially may be eligible for CCM. CONCLUSION: Only 5.1% of all patients presenting with heart failure might benefit from cardiac CCM. This is a small proportion of the overall heart failure population. However, this population has no other current option for device therapy of their condition.

A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection.

PURPOSE: Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to 'gold standard' monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor 'R' Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated. METHODS: Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated. RESULTS: RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001). CONCLUSIONS: All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications.

A trial of three non-invasive blood pressure monitors compared with invasive blood pressure assessment in atrial fibrillation and sinus rhythm.

OBJECTIVE: To investigate the accuracy of three non-invasive blood pressure (BP) devices in atrial fibrillation (AF) compared with invasive arterial BP. METHODS: One hundred patients aged 45-90 years, 63% male (50 in AF and 50 age matched controls in sinus rhythm [SR]) were identified with arterial lines measuring beat-to-beat BP fluctuation. Non-invasive BP measurements utilising the manual sphygmomanometer (MS), PulseCor R6.5 (PC) and automated sphygmomanometer (AS) were taken simultaneously with invasive BP in a randomised sequence. This was repeated three times in each patient. RESULTS: In SR differences in systolic BP (SBP) for MS, AS and PC were -0.34 mm Hg (95% CI -2.31 to 1.63; P = .733), -3.80 mm Hg (95% CI -5.73 to -1.87; P = .0001) and -3.90 mm Hg (95% CI -5.90 to -1.90; P = .0001) and for diastolic BP (DBP) were 6.02 mm Hg (95% CI 4.39-7.64; P < .0001), 8.95 mm Hg (95% CI 7.36-10.55; P < .0001) and 7.54 mm Hg (95% CI 5.89-9.18; P < .0001), respectively. In AF mean differences in SBP for MS, AS and PC were -7.33 mm Hg (95% CI -9.11 to -5.55; P < .0001), -5.29 mm Hg (95% CI -7.08 to -3.50; P < .0001) and -5.75 mm Hg (95% CI -7.54 to -3.96; P < .0001) respectively and for DBP were 5.28 mm Hg (95% CI 4.03-6.54; P < .0001), 6.26 mm Hg (95% CI 5.00-7.52; P < .0001) and 6.89 mm Hg (95% CI 5.64-8.15; P < .0001) respectively. CONCLUSIONS: The MS is accurate in SR because of direct assessment of Korotkoff sounds. Non-invasive BP assessment in AF is significantly less accurate. These findings have important prognostic and therapeutic implications.

Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence.

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.

The hemodynamic effects of a central iliac arteriovenous anastomosis at 6 months in patients with resistant and uncontrolled hypertension.

A central iliac arteriovenous anastomosis, termed the "coupler" (ROX Medical), results in a significant reduction in blood pressure (BP) in hypertensive patients. This study assessed functional and hemodynamic changes induced by the device. Twenty-one patients with resistant and/or uncontrolled hypertension underwent stress echocardiography and cardiopulmonary exercise testing (CPET) at baseline and 6 months post-coupler implantation. End points were selected to best evaluate cardiac function including Doppler stroke volume (SV), septal and lateral E/E', and right ventricular systolic velocity S' (RV S'). CPET VO2 peak demonstrated total cardiopulmonary performance. SV increased from 76.4 SD12.2 mL to 92.1 SD22.7 mL 6 months post-coupler insertion; P = .002. No changes in RV S', septal or lateral E/E', or VO2 peak were observed. Five patients experienced increased diuretic requirement ≥3 times baseline. RV S' fell from 19.0 SD1.87 cm/s to 16.80 SD3.43 cm/s in these patients (P > .05). A significant increase in SV 6 months post-coupler insertion was observed. In patients with increased diuretic requirement, the device was associated with a lower RV S' suggesting occult RV dysfunction as the mechanism of this pre-specified adverse outcome.

The effect of atrial fibrillation intervention on nocturnal respiratory events in elderly patients with persistent AF.

BACKGROUND: Sleep-disordered breathing (SDB) and atrial fibrillation (AF) are associated. This study investigated the impact of AF intervention on 6-month home sleep testing data. METHODS: Sixty-seven patients (aged 66 to 86, 53% male) with persistent AF were randomized (1:1:1) to direct current cardioversion (DCCV) (22 patients), permanent pacemaker (PPM) + atrioventricular node ablation (AVNA) + DCCV (22 patients) or AF ablation (23 patients). Baseline and 6-month multichannel home sleep tests with the Watch-PAT200 (Itamar Medical Lts., Caesarea, Israel) were recorded. Implantable cardiac monitors (ICMs) (Medtronic Reveal XT, Minneapolis, Minnesota) in the DCCV and AF ablation groups, and PPM Holters in the 'pace and ablate' group were utilized to assess cardiac rhythm beat-to-beat throughout the study period. RESULTS: The prevalence of moderate-to-severe SDB [apnoea-hypopnoea index (AHI) ≥ 15/h] was 60%. At 6 months there was no change in AHI, Epworth sleepiness scale, sleep time, % REM sleep, respiratory desaturation index or central apnoeic events. Twenty-five patients (15 AF ablation, 9 DCCV and 1 following DCCV post-AVNA) maintained SR at 6 months confirmed on ICMs in these patients. AHI fell from 29.8 ± 26.6/h to 22.2 ± 20.4/h; P = 0.049. CONCLUSIONS: SDB is highly prevalent in patients with persistent AF. Restoration of sinus rhythm, and the associated long-term recovery of haemodynamics, is associated with a significant reduction in AHI. This implicates reversal of fluid shift from the lower limbs to the neck region, a key mechanism in the pathogenesis of SDB.

Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension and paroxysmal AF.

A central iliac arteriovenous anastomosis, the 'coupler' (ROX Medical, California, USA) results in a significant reduction in blood pressure in hypertensive patients. This study assessed the change in AF burden following coupler implantation in patients with paroxysmal AF (PAF) and hypertension. Good blood pressure control using the coupler results in a significant reduction in AF burden.

A double-blind, randomised, placebo-controlled, cross-over study assessing the use of XEN-D0103 in patients with paroxysmal atrial fibrillation and implanted pacemakers allowing continuous beat-to-beat monitoring of drug efficacy.

PURPOSE: The ultrarapid delayed rectifier current (IKur) carried by Kv1.5 channels, which are solely expressed in the atrium, is a potential target for safer treatment of paroxysmal atrial fibrillation (PAF). XEN-D0103 is a nanomolar ion channel blocker that selectively inhibits potassium ion flux through the Kv1.5 ion channel. The efficacy of XEN-D0103 in reducing AF burden was assessed in patients with DDDRp permanent pacemakers (PPMs) and PAF. METHODS: A double-blind, placebo-controlled, cross-over study was performed in patients with PAF and DDDRp PPMs with advanced atrial and ventricular Holters allowing beat-to-beat arrhythmia follow-up. All anti-arrhythmic drugs were withdrawn before randomised treatment. After baseline assessment, patients were randomly assigned to two treatment periods of placebo then XEN-D0103 50 mg bd, or XEN-D0103 50 mg bd then placebo. RESULTS: Fifty-four patients were screened and 21 patients were eligible and included in the randomised trial. All 21 patients completed both treatment periods. The primary endpoint was change in AF burden assessed by PPM. There was no significant difference in AF burden on treatment with XEN-D0103 versus placebo. There was a reduction in the mean frequency of AF episodes (relative reduction 0.72, 95% CI 0.66 to 0.77; p < 0.0001). XEN-D0103 was safe and well tolerated, and there were no serious adverse events. XEN-D0103 did not have any apparent effect on heart rate compared to placebo. CONCLUSIONS: XEN-D0103 did not reduce AF burden in patients with PAF and dual chamber pacemakers providing beat-to-beat monitoring. XEN-D0103 was well tolerated and did not have any apparent effect on heart rate. Although single-ion channel blockade with XEN-D0103 did not affect AF in this study, there might be a potential for this agent to be used in combination with other atrially specific drugs in the treatment of AF. EUDRACT TRIAL REGISTRATION NUMBER: 2013-004456-38.

Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation.

Aims: To investigate the effect of minimally invasive thoracoscopic surgical ablation and nMARQ irrigated multi-electrode phased radiofrequency (RF) ablation to treat paroxysmal atrial fibrillation (AF) compared with PVAC multi-electrode phased RF ablation, with beat-to-beat device-derived Holter monitoring throughout the study duration. Methods and results: An investigator-initiated prospective trial of patients with paroxysmal AF randomized (1:1:1) to initial surgical, nMARQ or PVAC ablation. All patients had continuous beat-to-beat monitoring with an ILR or pacemaker to evaluate and document AF recurrence. There was a strong trend (P = 0.050) toward difference in AF outcome, with surgical AF ablation more efficacious than catheter ablation. At one year, the proportion of patients with less than 1% AF burden after one procedure and off all antiarrhythmic drugs was 63, 56, and 90% for PVAC, nMARQ and surgical ablations respectively. There were significantly more repeat ablations in the catheter ablation groups (P = 0.008): 25% PVAC, 27% nMARQ, 0% surgery. However, 7 of 20 (35%) of patients undergoing surgical ablation suffered a procedural complication, including two sternotomies for bleeding and one death. This was higher than for catheter ablation (P < 0.001). Surgical ablation took longer to perform (P < 0.001) and had a longer hospital admission (P < 0.001) than catheter ablation. Conclusion: Surgical AF ablation required significantly fewer repeat procedures than catheter ablation, and there was a clear trend towards improved arrhythmia outcome. However, it was associated with a significantly higher rate of procedural complications. Surgical ablation for paroxysmal AF is promising, however more prospective outcome data is required. Clinical Trial Registration: NCT01504451, http://clinicaltrials.gov/show/NCT01504451.

Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial.

Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP ≥140 mm Hg and average daytime ambulatory BP ≥135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone. At 12 months, 39 patients who had coupler therapy were included in the intention-to-treat analysis. Office-based systolic BP reduced by 25.1±23.3 mm Hg (baseline, 174±18 mm Hg; P<0.0001) post-coupler placement, and office diastolic BP reduced by 20.8±13.3 mm Hg (baseline, 100±13 mm Hg; P<0.0001). Mean 24-hour ambulatory BP reduced by 12.6±17.4/15.3±9.7 mm Hg (P<0.0001 for both). In a prespecified subset of patients who failed to respond adequately to prior renal denervation, coupler therapy led to highly significant reduction in office systolic/diastolic BP (30.7/24.1 mm Hg) and significant reduction in 24-hour ambulatory systolic/diastolic BP (12.4/14.4 mm Hg) at 12 months (n=9). After coupler therapy, 14 patients (33%) developed ipsilateral venous stenosis; all were treated successfully with venous stenting. These findings confirm the importance of arterial mechanics in the pathophysiology of hypertension and support the clinical use of a central iliac arteriovenous anastomosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.

Clinical events and echocardiographic lesion progression rate in subjects with mild or moderate aortic regurgitation.

Background: The rate of progression of aortic regurgitation (AR) is not well described. Current guidelines state that asymptomatic patients with mild AR should be followed up every 3­5 years and 1­2 yearly for moderate AR. This study describes the lesion and clinical based progression of mild and moderate AR in a population of patients undergoing systematic follow-up. Methods and results: 341 patients with either mild or moderate AR were included. The rates of clinical events (death, aortic valve replacement and cardiac hospitalization) and progression of AR are reported. 341 patients were included; mean age was 71.1 years (IQR 66­80 years) and the median follow-up period was 4.6 (IQR 2­6.7) years. 292 patients did not have any events during follow-up. 3 patients required aortic valve replacement (2 of these due to severe aortic stenosis and 1 due to severe mitral regurgitation and co-existent moderate AR). 44 patients required cardiac hospitalization. 9 patients died during follow-up and 35 patients (10%) showed a progression of AR during follow-up with an average time of 4.0 ± 2.6 years. 8 patients (2.3% of the total) progressed to severe AR. Patients with mixed valvular pathology showed a greater increase in AR progression (27 (15%) vs 8 (5%); P = 0.004). Conclusions: Over medium term systematic follow-up progression and clinical events in patients with AR is rare, regardless of etiology. Patients who suffered from AR as an isolated valve pathology were less likely to show AR progression over time.

Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension.

BACKGROUND: Options for interventional therapy to lower blood pressure (BP) in patients with treatment-resistant hypertension include renal denervation and the creation of an arteriovenous anastomosis using the ROX coupler. It has been shown that BP response after renal denervation is greater in patients with combined hypertension (CH) than in patients with isolated systolic hypertension (ISH). We analyzed the effect of ROX coupler implantation in patients with CH as compared with ISH. METHODS AND RESULTS: The randomized, controlled, prospective ROX Control Hypertension Study included patients with true treatment-resistant hypertension (office systolic BP ≥140 mm Hg, average daytime ambulatory BP ≥135/85 mm Hg, and treatment with ≥3 antihypertensive drugs including a diuretic). In a post hoc analysis, we stratified patients with CH (n=31) and ISH (n=11). Baseline office systolic BP (177±18 mm Hg versus 169±17 mm Hg, P=0.163) and 24-hour ambulatory systolic BP (159±16 mm Hg versus 154±11 mm Hg, P=0.463) did not differ between patients with CH and those with ISH. ROX coupler implementation resulted in a significant reduction in office systolic BP (CH: -29±21 mm Hg versus ISH: -22±31 mm Hg, P=0.445) and 24-hour ambulatory systolic BP (CH: -14±20 mm Hg versus ISH: -13±15 mm Hg, P=0.672), without significant differences between the two groups. The responder rate (office systolic BP reduction ≥10 mm Hg) after 6 months was not different (CH: 81% versus ISH: 82%, P=0.932). CONCLUSIONS: Our data suggest that creation of an arteriovenous anastomosis using the ROX coupler system leads to a similar reduction of office and 24-hour ambulatory systolic BP in patients with combined and isolated systolic hypertension. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.