Dataset Information

Use of Pre- and Intensified Postprocedural Physiotherapy in Patients with Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Study (the 4P-TAVR Study).

ABSTRACT:

Background

Physiotherapy prior to open-heart surgery lowers the rate of pneumonia and length of the hospital stay. Pneumonia is a major contributor to short-term mortality following transcatheter aortic valve replacement (TAVR). Hence, we hypothesized that pre- and intensified postprocedural physiotherapy in patients undergoing TAVR might impact the net functional and clinical outcome.

Methods and results

The 4P-TAVR study was a prospective, monocentric, randomized trial. The study was designed to compare the efficacy and safety of intensified periprocedural physiotherapy including inspiratory muscle training versus standard postprocedural physiotherapy. Patients were randomized in a 1?:?1 fashion. 108 patients were included and followed up for 90 days after TAVR. While patients in group A (control group: 50 patients, age: 81.7?±?5.0 years, 52% male) did not receive physiotherapy prior to TAVR, group B (intervention group: 58 patients, age: 82.2?±?5.82 years, 47% male) participated in intensive physiotherapy. Compared to the control group, patients in the interventional group showed a lower incidence of postinterventional pneumonia (10 [20.0%] vs. 3 [5.1%], p=0.016) and had a 3-day shorter mean hospital stay (13.5?±?6.1 days vs. 10.1?±?4.7 days, p=0.02). The primary composite endpoint of mortality and rehospitalization was not different between the groups.

Conclusion

Intensified physiotherapy is safe and has positive effects on clinical outcomes up to 90 days after TAVR but has no impact on the primary combined endpoint of mortality and rehospitalization. Longer follow-up, a multicenter design, and a higher number of subjects are needed to confirm these preliminary results. This trial is registered with DRKS00017239.

SUBMITTER: Weber M

PROVIDER: S-EPMC7826236 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Use of Pre- and Intensified Postprocedural Physiotherapy in Patients with Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Study (the 4P-TAVR Study).

Weber M M Klein U U Weigert A A Schiller W W Bayley-Ezziddin V V Wirtz D C DC Welz A A Werner N N Grube E E Nickenig G G Sinning J-M JM Ghanem A A

Journal of interventional cardiology 20210116

<h4>Background</h4>Physiotherapy prior to open-heart surgery lowers the rate of pneumonia and length of the hospital stay. Pneumonia is a major contributor to short-term mortality following transcatheter aortic valve replacement (TAVR). Hence, we hypothesized that pre- and intensified postprocedural physiotherapy in patients undergoing TAVR might impact the net functional and clinical outcome.<h4>Methods and results</h4>The 4P-TAVR study was a prospective, monocentric, randomized trial. The stud ...[more]

PMID: 33531881

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Project description:ImportanceReducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR).ObjectiveThis study evaluated the trends of stroke occurring within 30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk.Design, setting, and participantsRetrospective cohort study including 101 430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017.ExposuresTAVR.Main outcomes and measuresThe rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively.ResultsAmong 101 430 patients included in the study (median age, 83 years [interquartile range {IQR}, 76-87 years]; 47 797 women [47.1%]; and 85 147 patients [83.9%] treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99 140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio [HR], 6.1 [95% CI, 5.4-6.8]; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83).Conclusions and relevanceBetween 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.

Project description:Transcatheter mitral valve replacement (TMVR) is currently being investigated as a procedural alternative to surgical mitral valve repair or replacement (SMVR). Early data from first-in-man trials with current devices suggest that TMVR is technically feasible but carries a high mortality. This is substantially different from the early success transcatheter aortic valve replacement (TAVR) has seen and is related to complexities of the mitral valve anatomy, differences in pathology that require mitral valve replacement as well as the impact that mitral valve replacement has on physiology and cardiac function, irrespective of the modality by which the mitral valve is replaced. Importantly, in the case of TAVR, a less invasive method is offered to accomplish the same as the traditional surgical intervention. On the other hand, valve replacement is not the recommended treatment option for the majority of mitral valve disease, and in fact is avoided whenever possible during surgery given the shortened life expectancy and increased morbidity with mitral valve replacement. Another distinction between TAVR and TMVR is the etiology and natural progression of the underlying disease and driving factors for intervention that are vastly different between aortic and mitral valve disease. The primary aortic disease treated has been aortic stenosis, which has several etiologic factors that cause a similar physiologic dysfunction and risk. Aortic valve replacement leads to improved survival and quality of life. The primary mitral valve disease targeted is regurgitation, which occurs as a primary valve defect and as a secondary consequence of ventricular dysfunction. Primary mitral regurgitation is treated by valve repair with excellent long-term outcomes. Secondary regurgitation has poor long-term outcomes with current commonly used repair techniques and limited data exists showing that correction of the regurgitation improves survival. Adoption of TMVR will require overcoming the anatomic challenges as well as generating data that supports improved survival and/or quality of life.

Project description:BackgroundImpaired left ventricular (LV) ejection fraction is a common finding in patients with aortic stenosis and serves as a predictor of morbidity and mortality after transcatheter aortic valve replacement. However, conflicting data on the most accurate measure for LV function exist. We wanted to examine the impact of LV ejection fraction, mean pressure gradient, and stroke volume index on the outcome of patients treated by transcatheter aortic valve replacement.Methods and resultsPatients treated by transcatheter aortic valve replacement were primarily separated into normal flow (NF; stroke volume index >35 mL/m2) and low flow (LF; stroke volume index ?35 mL/m2). Afterwards, patients were divided into 5 groups: "NF-high gradient," "NF-low gradient" (NF-LG), "LF-high gradient," "paradoxical LF-LG," and "classic LF-LG." The 3-year mortality was the primary end point. Of 1600 patients, 789 (49.3%) were diagnosed as having LF, which was characterized by a higher 30-day (P=0.041) and 3-year (P<0.001) mortality. LF was an independent predictor of all-cause (hazard ratio, 1.29; 95% confidence interval, 1.03-1.62; P=0.03) and cardiovascular (hazard ratio, 1.37; 95% confidence interval, 1.06-1.77; P=0.016) mortality. Neither mean pressure gradient nor LV ejection fraction was an independent predictor of mortality. Patients with paradoxical LF-LG (35.0%), classic LF-LG (35.1%) and LF-high gradient (38.1%) had higher all-cause mortality at 3 years compared with NF-high gradient (24.8%) and NF-LG (27.9%) (P=0.001). However, surviving patients showed a similar improvement in symptoms regardless of aortic stenosis entity.ConclusionsLF is a common finding within the aortic stenosis population and, in contrast to LV ejection fraction or mean pressure gradient, an independent predictor of all-cause and cardiovascular mortality. Despite increased long-term mortality, high procedural success and excellent functional improvement support transcatheter aortic valve replacement in patients with LF severe aortic stenosis.

Dataset Information

Use of Pre- and Intensified Postprocedural Physiotherapy in Patients with Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Study (the 4P-TAVR Study).

Background

Methods and results

Conclusion

Publications

Use of Pre- and Intensified Postprocedural Physiotherapy in Patients with Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Study (the 4P-TAVR Study).

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