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  • Ovid Technologies (Wolters Kluwer Health)  (13)
  • Lurz, Philipp  (13)
  • 1
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    Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies : Insights From a Randomized Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Hypertension Vol. 74, No. 2 ( 2019-08), p. 341-348
    Details
    In: Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 74, No. 2 ( 2019-08), p. 341-348
    Abstract: Patients with isolated systolic hypertension (ISH) are thought to show a diminished blood pressure (BP)–lowering effect after renal sympathetic denervation (RDN). This conclusion is mostly derived from unipolar radiofrequency catheter ablation studies. Limited data for newer RDN technologies exist. We used data from the RADIOSOUND-HTN (Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension) comparing 3 different RDN approaches to investigate a possible interaction between ISH and RDN response. One hundred twenty patients were stratified by having ISH or combined systolic-diastolic hypertension (CH). Of these, 39 underwent radiofrequency ablation of the renal main arteries, 39 combined radiofrequency ablation of the main and branch arteries, and 42 were treated with ultrasound-based ablation of the main renal artery. Patients with ISH (n=61) were older and had lower systolic and diastolic BP on ambulatory measurement (ambulatory BP measurement) at baseline in comparison to CH (n=59). At 3 months, patients with ISH showed a less pronounced BP-lowering effect of RDN as compared to patients with CH (daytime average −5.9±11.8 versus −13.3±11.7 mm Hg, P =0.001). This difference was significant for radiofrequency ablation of the renal main arteries and ultrasound-based ablation of the main renal artery treatment but did not reach significance in the radiofrequency ablation of the main and branch arteries group. After adjustment for baseline BP values and age, there was no significant difference in BP reduction between ISH and CH. Using unadjusted BP values, RDN seems to be more effective in CH than in ISH. However, adjusting for baseline BP values revealed similar BP reduction in ISH and CH patients, irrespective of the RDN treatment used. The value of ISH as predictor for successful RDN might have been overestimated in the past. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02920034.
    Type of Medium: Online Resource
    ISSN: 0194-911X , 1524-4563
    URL: Article
    DOI: 10.1161/HYPERTENSIONAHA.119.13019
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 2
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    Comparison of Long‐Term Outcomes for Responders Versus Non‐Responders Following Renal Denervation in Resistant Hypertension
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of the American Heart Association Vol. 10, No. 21 ( 2021-11-02)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 21 ( 2021-11-02)
    Abstract: Recent trial results support the efficacy of renal sympathetic denervation in lowering blood pressure (BP). While BP reduction in general is associated with a clinically meaningful reduction in cardiovascular events and mortality, such a relationship has not been described for patients undergoing renal sympathetic denervation. Methods and Results Clinical events were assessed in patients who underwent renal sympathetic denervation at our center using telephone‐ and clinical follow‐up, interviews with general practitioners, as well as review of hospital databases. Event rates were compared between BP responders (≥5 mm Hg 24‐hour ambulatory BP reduction) and non‐responders; 296 patients were included. Compared with baseline, 24‐hour systolic ambulatory BP was reduced by 8.3±12.2 mm Hg and diastolic BP by 4.8±7.0 mm Hg ( P 〈 0.001 for both) after 3 months. One hundred eighty patients were classified as BP responders and 116 as non‐responders. During a median follow‐up time of 48 months, significantly less major adverse cardiovascular events (cardiovascular death, stroke, myocardial infarction, critical limb ischemia, renal failure) occurred in responders than in non‐responders (22 versus 23 events, hazard ratio [HR], 0.53 [95% CI, 0.28 to 0.97] , P =0.041). This was consistent after adjustment for potential confounders as well as confirmed by propensity‐score matching. A proportional relationship was found between BP reduction after 3 months and frequency of major adverse cardiovascular events (HR, 0.75 [95% CI, 0.58 to 0.97] per 10 mm Hg 24‐hour systolic ambulatory BP reduction). Conclusions Based on these observational data, blood pressure response to renal sympathetic denervation is associated with improved long‐term clinical outcome.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.121.022429
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 3
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    Twenty‐Four‐Month Blood Pressure Results After Renal Denervation Using Endovascular Ultrasound
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Journal of the American Heart Association Vol. 12, No. 16 ( 2023-08-15)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 16 ( 2023-08-15)
    Abstract: Renal denervation has proven its efficacy to lower blood pressure in comparison to sham treatment in recent randomized clinical trials. Although there is a large body of evidence for the durability and safety of radiofrequency‐based renal denervation, there are a paucity of data for endovascular ultrasound–based renal denervation (uRDN). We aimed to assess the long‐term efficacy and safety of uRDN in a single‐center cohort of patients. METHODS AND RESULTS Data from 2 previous studies on uRDN were pooled. Ambulatory 24‐hour blood pressure measurements were taken before as well as 3, 6, 12, and 24 months after treatment with uRDN. A total of 130 patients (mean age 63±9 years, 24% women) underwent uRDN. After 3, 6, 12, and 24 months, systolic mean 24‐hour ambulatory blood pressure values were reduced by 10±12, 10±14, 8±15, and 10±15 mm Hg, respectively, when compared with baseline ( P 〈 0.001). Corresponding diastolic values were reduced by 6±8, 6±8, 5±9, and 6±9 mm Hg, respectively ( P 〈 0.001). Periprocedural adverse events occurred in 16 patients, and all recovered without sequelae. CONCLUSIONS In this single‐center study, uRDN effectively lowered blood pressure up to 24 months after treatment.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.123.030767
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 4
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    Pulse Wave Velocity Predicts Response to Renal Denervation in Isolated Systolic Hypertension
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Journal of the American Heart Association Vol. 6, No. 5 ( 2017-05-05)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 6, No. 5 ( 2017-05-05)
    Abstract: Renal sympathetic denervation seems to be less effective as a treatment for hypertension in patients with isolated systolic hypertension, a condition associated with elevated central arterial stiffness. Because isolated systolic hypertension can also be caused by wave reflection or increased cardiac output, a more differentiated approach might improve patient preselection for renal sympathetic denervation. We sought to evaluate the additional predictive value of invasive pulse wave velocity for response to renal sympathetic denervation in patients with combined versus isolated systolic hypertension. Methods and Results Patients scheduled for renal sympathetic denervation underwent additional invasive measurement of pulse wave velocity and pulse pressure before denervation. Blood pressure was assessed via ambulatory measurement at baseline and after 3 months. In total 109 patients (40 patients with isolated systolic hypertension) were included in our analysis. After 3 months, blood pressure reduction was more pronounced among patients with combined hypertension compared with patients with isolated systolic hypertension (systolic 24‐hour average 9.3±10.5 versus 5.0±11.5 mm Hg, P =0.046). However, when stratifying patients with isolated systolic hypertension by invasive pulse wave velocity, patients in the lowest tertile of pulse wave velocity had comparable blood pressure reduction (12.1±12.6 mm Hg, P =0.006) despite lower baseline blood pressure than patients with combined hypertension (systolic 24‐hour average 154.8±12.5 mm Hg in combined hypertension versus 141.2±8.1, 148.4±10.9, and 150.5±12.7 mm Hg, respectively, by tertiles of pulse wave velocity, P =0.002). Conclusions Extended assessment of arterial stiffness can help improve patient preselection for renal sympathetic denervation and identify a subgroup of isolated systolic hypertension patients who benefit from sympathetic modulation.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.117.005879
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 5
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    Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Circulation: Cardiovascular Interventions Vol. 15, No. 7 ( 2022-07)
    Details
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 15, No. 7 ( 2022-07)
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    URL: Article
    DOI: 10.1161/CIRCINTERVENTIONS.122.011993
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2450801-9
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  • 6
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    General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation : The Randomized SOLVE-TAVI Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Circulation Vol. 142, No. 15 ( 2020-10-13), p. 1437-1447
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. 15 ( 2020-10-13), p. 1437-1447
    Abstract: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. Results: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, −6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, −2.9 to 4.8]; P equivalence 〈 0.001); stroke, 2.4% versus 2.8% (rate difference, −0.4 [90% CI, −3.8 to 3.8]; P equivalence 〈 0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, −3.0 to 3.9]; P equivalence 〈 0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, −0.9 [90% CI, −7.5 to 5.7]; P equivalence =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, −0.2 [90% CI, −5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, −34.4 [90% CI, −41.0 to −27.8]). Conclusions: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02737150.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/CIRCULATIONAHA.120.046451
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
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  • 7
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    Abstract 18891: Prospective Evaluation of Diagnostic Performance and Safety of Implementing a Biventricular Approach for Endomyocardial Biopsy in Patients With Suspected Myocarditis
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Circulation Vol. 130, No. suppl_2 ( 2014-11-25)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 130, No. suppl_2 ( 2014-11-25)
    Abstract: Background: Previous retrospective analyses have suggested that biventricular (BV) endomyocardial biopsy (EMB) is superior to right (RV) or left ventricular (LV) EMB only in diagnosing patients with suspected myocarditis. Aim: To prospectively assess the feasibility, safety and diagnostic yield of BV EMB in consecutive patients with suspected myocarditis. Methods: Five to six EMBs were taken from the RV and LV under fluoroscopic guidance. Biopsies were analyzed in a core lab by highly experienced investigators (KK, RK) Myocarditis/myocardial in[[Unable to Display Character: & #64258;]]ammation was de[[Unable to Display Character: & #64257;]]ned as the detection of ≥14 infiltrating leukocytes/mm2 (CD3 T-lymphocytes and/or CD68 macrophages) in addition to enhanced HLA class II expression in professional antigen-presenting immune cells. Results: 100 consecutive patients (mean age 44 ± 15 years) with clinically suspected myocarditis were included. RV EMB was attempted in 100 patients, in 3 the procedure was abandoned due to unsatisfying positioning on the guiding catheter, in 1/97 RV EMBs were inadequate with no myocardial tissue obtained. LV EMB was attempted in 97 patients, in 3, LV EMB was not performed due to presence of LV thrombi, in 1/97 patient LV EMBs were inadequate with no myocardial tissue obtained. Major complication rate for LV EMB was 0% and for RV EMB, 1% (pericardial tamponade requiring surgical revision). Results of adequate BV EMBs were analyzed in 92 patients. On BV EMB, myocarditis was diagnosed in 61/92 patients. When considering LV EMB only, the diagnosis would have been missed in 3/61, when considering RV EMB only in 7/61 patients. Conclusion: BV EMB is feasible and safe in the majority of patients with suspected myocarditis and yields in a superior diagnostic performance as compared to a single ventricle EMBs.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.130.suppl_2.18891
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 8
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    Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Hypertension Vol. 65, No. 6 ( 2015-06), p. 1202-1208
    Details
    In: Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 65, No. 6 ( 2015-06), p. 1202-1208
    Abstract: Few data are available with regard to the effectiveness of renal sympathetic denervation in patients with resistant hypertension yet only mildly elevated blood pressure (BP). Patients with resistant hypertension and slightly elevated BP (day-time systolic pressure, 135–149 and diastolic pressure, 90–94 mm Hg on 24-hour ambulatory measurement) were randomized in a 1:1 ratio to renal sympathetic denervation with the Symplicity Flex Catheter (Medtronic) or an invasive sham procedure. The primary efficacy end point was the change in 24-hour systolic BP at 6 months between groups in the intention to treat population. A total of 71 patients underwent randomization. Baseline day-time systolic BP was 144.4±4.8 mm Hg in patients assigned to denervation and 143.0±4.7 mm Hg in patients randomized to the sham procedure. The mean change in 24-hour systolic BP in the intention to treat cohort at 6 months was −7.0 mm Hg (95% confidence interval, −10.8 to −3.2) for patients undergoing denervation and −3.5 mm Hg (95% confidence interval, −6.7 to −0.2) in the sham group ( P =0.15). In the per protocol population, the change in 24-hour systolic BP at 6 months was −8.3 mm Hg (95% confidence interval, −11.7 to −5.0) for patients undergoing denervation and −3.5 mm Hg (95% confidence interval, −6.8 to −0.2) in the sham group ( P =0.042). In patients with mild resistant hypertension, renal sympathetic denervation failed to show a significant reduction in the primary end point of 24-hour systolic BP at 6 months between groups in the intention to treat analysis. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01656096.
    Type of Medium: Online Resource
    ISSN: 0194-911X , 1524-4563
    URL: Article
    DOI: 10.1161/HYPERTENSIONAHA.115.05283
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 9
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    Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction : Randomized SHOCK-COOL Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Circulation Vol. 139, No. 4 ( 2019-01-22), p. 448-457
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 4 ( 2019-01-22), p. 448-457
    Abstract: Experimental trials suggest improved outcome by mild therapeutic hypothermia for cardiogenic shock after acute myocardial infarction. The objective of this study was to investigate the hemodynamic effects of mild therapeutic hypothermia in patients with cardiogenic shock complicating acute myocardial infarction. Methods: Patients (n=40) with cardiogenic shock undergoing primary percutaneous coronary intervention without classic indications for mild therapeutic hypothermia underwent randomization in a 1:1 fashion to mild therapeutic hypothermia for 24 hours or control. The primary end point was cardiac power index at 24 hours; secondary end points included other hemodynamic parameters and serial measurements of arterial lactate. Results: No relevant differences were observed for the primary end point of cardiac power index at 24 hours (mild therapeutic hypothermia versus control: 0.41 [interquartile range, 0.31–0.52] versus 0.36 [interquartile range, 0.31–0.48] W/m 2 ; P =0.50; median difference, −0.025 W/m 2 ; 95% CI, −0.12 to 0.06). Similarly, all other hemodynamic measurements were not statistically different. Arterial lactate levels at 6, 8, and 10 hours were significantly higher in patients in the mild therapeutic hypothermia group with a slower decline ( P for interaction=0.03). There were no differences in 30-day mortality (60% versus 50%; hazard ratio, 1.27; 95% CI, 0.55–2.94; P =0.55). Conclusions: In this randomized trial, mild therapeutic hypothermia failed to show a substantial beneficial effect on cardiac power index at 24 hours in patients with cardiogenic shock after acute myocardial infarction. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01890317.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/CIRCULATIONAHA.117.032722
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 10
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    Renal Sympathetic Denervation in Patients With Heart Failure With Preserved Ejection Fraction
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Circulation: Heart Failure Vol. 14, No. 3 ( 2021-03)
    Details
    In: Circulation: Heart Failure, Ovid Technologies (Wolters Kluwer Health), Vol. 14, No. 3 ( 2021-03)
    Abstract: Arterial hypertension is the most common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and mediates adverse hemodynamics through related aortic stiffness and increased pulsatile load. We aimed to investigate the clinical and hemodynamic implications of renal sympathetic denervation (RDN) in patients with HFpEF and uncontrolled arterial hypertension. Methods: Patients undergoing RDN between 2011 and 2018 in a single-center were retrospectively analyzed and classified as HFpEF (n=99) or no HF (n=65). Stroke volume index and aortic distensibility were measured through cardiac magnetic resonance imaging, and left ventricular (LV) systolic and diastolic properties were assessed echocardiographically. Results: At baseline, patients with HFpEF had higher stroke volume index (median 40 [interquartile range, 33–48] versus 33 [26–40] mL/m 2 , P =0.002), pulse pressure (69 [63–77] versus 61 [55–67] mm Hg, P 〈 0.001), but lower LV-VPES 100mm Hg (18 [10–28] versus 24 [15–40] mL, P =0.007) and aortic distensibility (1.5 [1.1–2.6] versus 2.7 [1.1–3.5] 10 −3 mm Hg −1 , P =0.013) as compared to no-HF patients. Systolic blood pressure decreased comparable in patients with HFpEF and no-HF patients following RDN (−9 [−16 to −2], P 〈 0.001). After RDN stroke volume index (−3 [−9 to +3] mL/m 2 , P =0.011) decreased and aortic distensibility (0.2 [−0.1 to +1.1] 10 −3 mm Hg −1 , P =0.007) and systolic stiffness ( P 〈 0.001) increased in HFpEF patients. LV diastolic stiffness and LV filling pressures as well as NT-proBNP (N-terminal pro-B-type natriuretic peptide) decreased after RDN in patients with HFpEF ( P =0.032, P =0.043, and P 〈 0.001, respectively). Conclusions: Patients with HFpEF undergoing RDN showed increased stroke volume index, vascular, and LV stiffness as compared to no-HF patients. Following RDN those hemodynamic alterations and reduced systolic and diastolic LV stiffness were partly normalized, implying RDN might be a potential therapeutic strategy for arterial hypertension and HFpEF.
    Type of Medium: Online Resource
    ISSN: 1941-3289 , 1941-3297
    URL: Article
    DOI: 10.1161/CIRCHEARTFAILURE.120.007421
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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