Effectiveness of Human Amniotic Membrane Membrane Wrapping for

Increasing Range of Motion in Hand Flexor Tendon Repair : a Systematic

Review
Riyan

Abstrak
Latar belakang: Sebuah modifikasi postur ditambahkan pada Manuver Valsalva yang mungkin dapat
meningkatkan keberhasilan dalam mengkonversi irama Takikardia Supraventrikuler (TSV) dengan
hemodinamik stabil menjadi irama sinus. Tujuan dari studi ini adalah membandingkan Manuver
Valsalva Standar dan Manuver Valsalva Termodifikasi dalam menatalaksana pasien TSV dengan
hemodinamik stabil.

Metode: Studi ini adalah laporan kasus berbasis bukti. Pencarian bukti dari situs Pubmed, Scopus,
EBSCOhost, Proquest, dan Cochrane. Kata kunci yang digunakan adalah Valsalva, Modified Valsalva,
SVT or Supraventricular Tachycardia, and Treatment dengan MeSH. Studi terapi yang terpilih akan
dilakukan seleksi dan didapatkan empat studi.

Hasil: Telaah kritis dilakukan pada empat studi menggunakan Oxford CEBM Telaah Terapi dan
ditemukan bahwa valsalva yang termodifikasi memiliki tingkat konversi lebih baik daripada valsalva
standar. Manuver Valsalva yang termodifikasi juga mengurangi pemakaian obat-obatan anti aritmia.
Tidak ada perbedaan yang signifikan dari efek samping yang ditimbulkan.

Kesimpulan: Manuver Valsalva yang termodifikasi aman, hemat biaya, dan lebih efektif dibanding
Manuver Valsalva Standard dalam mentatalaksana pasien TSV dengan hemodinamik stabil.

Abstract
Background: Flexor tendon adhesion to surrounding tissues after repair is the most common
complication. Adhesion causes limitation in Range of Motion. Several methods and materials have been
explored such as
improved suturing techniques, early rehabilitation training after operation, local application of drugs to
inhibit inflammatory response, or inhibition of cytokine release but adhesion after tendon injury repair is
difficult to prevent in clinical practice. Human Amniotic Membrane is an ideal biomaterial and rich of
cytokines to decrease fibrotic response and tendon adhesion. The aim of this study to determine the
effectiveness of Human Amniotic Membrane Membrane Wrapping for Increasing Range of Motion in
Hand Flexor Tendon Repair.

Methods: A systematic search was conducted in the electronic databases (PubMed, Scopus, Ebscohost,
Proquest and ScienceDirect), identifying observational studies within 10 years prior to 2021. Diabetic
ulcer and Topical Propolis were used as keywords. Each article reviewed for quality and clinical
relevance.

Result: Four studies relevant in answering the question were appraised using Oxford CEBM Therapy
Study Appraisal. Modified Valsalva had higher conversion rate to sinus rhytm then standard valsalva.
Modified Valsalva also use less anti-arrhythmic therapy than standard valsalva. There were no differences
in adverse event produced.

Conclusion: Modified Valsalva Maneuver is safe, cost efficient, and more effective than Standard
Valsalva Maneuver in converting hemodynamically stable SVT patients to sinus rhythm.
Keywords: Modified Valsalva, Standard Valsalva, supraventricular tachycardia, treatment
INTRODUCTION
Cardiac Arrythmias were caused by 3 main disorders; impulse formation disorder (automaticity
and triggered activity), impulse conduction disorder (block formation [with/without reentry] and
reflection), and the combination of the two disorders. Supraventricular Tachycardia (SVT) is a
dysrhythmia originating above the atrioventricular (AV) node and it is usually associated with
impulse conduction disorder in which reentry occurs.1 SVT is a common tachyarrhythmia
presented in emergency settings and Atrioventricular nodal re-entry tachycardia (AVNRT) is the
most common non-sinus tachydysrhythmia.2,3 In this article we use SVT as a term to describe re-
entry tachycardias: atrioventricular nodal reentry tachycardia (AVNRT) and atrioventricular
reentry/reciprocating tachycardia (AVRT). AV node plays a significant role in the re-entry
circuit causing SVT and as a consequence, it needs to be blocked. Vagal maneuver was known to
be able to block the AV node and convert SVT to sinus rhythm.2,4

The Standard Valsava Maneuver, a part of the Vagal Maneuver, is a technique to treat
hemodynamic stable patients with SVT as written in the 2015 ACC/AHA/HRS guideline. 5 It is
performed by blowing for 10-15s, bearing down as if they are having a bowel movement. 2 A
10ml syringe can be used to encourage patients to blow and reaching the optimal pressure. In
infants and toddlers, ice packs can be applied on the face and producing a similar vagal tone. 2,6
Valsalva maneuver is considered as the primary treatment in hemodynamically stable SVT. Its
success rate varied in the literature from 6% to 54%. 7-9 This wide range of success rate may pose
a problem because a failure in Valsalva Maneuver will lead to Adenosine injection that gives the
patients unpleasant experience and can cause transient asystole.10

A modification had been added to Valsalva Maneuver by supine positioning the patient with leg
elevation immediately after blow. The modification increase the vagal tone and it was then
known as Modified Valsalva Maneuver.4,6,10 This modification might increase the chance of
success in converting the patients and lead to less adenosine use. This paper will review several
randomized controlled trials of Modified Valsalva Maneuver and its success rate in converting
patients from SVT to sinus rhythm.

Case Illustration
A 60-years old man came to emergency room (ER) with a chief complaint of feeling palpitations
for almost an hour. The patient was just walking in the morning when he suddenly felt his heart
was beating faster than ever before. He admitted that this had never happened before. He was
diagnosed with hypertension 10 years ago and currently; he was consuming captopril 2x12.5 mg
daily. From the physical examinations, we found that the patient was tachycardia with 140 bpm
with stable hemodynamic. The ECG showed AVNRT with 188 bpm and no other abnormalities
were found. We diagnosed the patient as paroxysmal supraventricular tachycardia and then we
performed Valsalva Maneuver. Conversion to sinus rhythm was not achieved after 3 cycle of
Valsalva Maneuver (a cycle of Valsalva Maneuver is 15 sec blowing 10 ml syringe with 45 sec
rest on semi recumbent position). 6 mg of Adenosine injection was given and terminated the
SVT. Laboratory results were unremarked. The patient was observed for another 8 hours before
being discharged and was scheduled for follow-up.
Figure 1. The ECG of the 60-years old man showed short RP SVT with 188 bpm heart rate,
normal axis, undetermined P wave, QRS < 120 ms, ST depression, and no hypertrophy or block.
Clinical Questions
Does Modified Valsalva Maneuver give a better conversion rhythm in stable hemodynamic
patients with supraventricular tachycardia compared to Standard Valsalva Maneuver?

Table 1. Clinical Question Formulation PICO

Clinical Question Formulation
Patient (P) Patient with supraventricular tachycardia
Intervention (I) Modified Valsalva Maneuver
Comparison (C) Standard Valsalva Maneuver
Outcome (O) Conversion rate to sinus rhythm
Type of question Treatment
METHODS
Searching Strategy and Article Selection
Literature searching was done by 2 independent authors on 15 May 2020 using Pubmed, Scopus,
EBSCOhost, Proquest, and Cochrane search engine. The keywords used were Valsalva,
Modified Valsalva, SVT or Supraventricular Tachycardia, and Treatment with their MeSH
terms. The inclusion criteria were; written in English, done on human, and a Randomized
Controlled-Trials, meta-analysis or systematic review. 12 studies were obtained after we
screened for the title and abstract. We filtered the studies again by filtering double and
eliminated 8 studies. 4 studies remaining were further reviewed with full text reading and all
studies were included.

Figure 2. Finding Strategy and Article Selection

Studies Appraisal
The Centre for Evidence-Based Medicine (CEBM) University of Oxford guidance was used to
appraised the four studies included in this study. The following was the appraisal of validity,
importance and applicability of each study.
RESULTS
Table 2. Critical Appraisal of Appelboam, A et al study10
Is this Randomized Controlled Trial valid?
Appelboam, A et al1
Was the assignment of Yes. All participants were randomly assigned (1:1) to a
patients to treatments standard Valsalva maneuver (control) or modified
randomized? Valsalva maneuver (intervention). Allocation
were prepared by an independent statiscian and
placed in serially numbered, opaque, sealed,
tamper-evident envelopes by the clinical trial
unit.
Were the groups similar at Yes. The baseline demographic characteristics between
the start of the trial? the two groups were similar.
Aside from the allocated Yes. The two groups were treated equally.
treatment, were groups
treated equally?
Were all patients who Yes. All patients that entered the trial was accounted to
entered the trial accounted their respective group and were analyzed
for? And were they analyzed according to intention to treat
in the groups to which they
were randomized?
Were measures objective or Yes The measures were objectives by achieving sinus
were the patients and rhythm with 12 lead ECG
clinicians kept “blind” to
which treatment was being
received?
How large was the treatment Within 1 minute of duration, 37/214 patients achieving
effect? sinus rhythm with Standard Valsalva (17%) and 93/214
patients with Modified Valsalva (43%). The relative risk
between the two groups were 2.5135 with 95% CI, 1.8061-
3.4980 (p<0.0001). Absolute risk reduction (ARR) was
26.1%. The relative risk reduction was 2.5135. The number
needed to treat (NNT) was 3.821
How precise was the The relative risk between the two groups was 2.5135 with
estimate of the treatment 95% CI, 1,8061-3,4980 (p<0,0001)
effect?
Is my patient so different to No. It can be applied.
those in the study that the
results cannot apply?
Is the treatment feasible in Yes. It is feasible.
my setting?
Will the potential benefits of Yes. The potential benefit of the treatment outweighs
treatment outweigh the the potential harms (no serious adverse events
 potential harms of treatment were reported).
for my patients?

Table 3. Critical Appraisal of Chen, C et al study11

Is this Randomized Controlled Trial valid?
Chen, C et al2
Was the assignment of Yes. All participants were randomly allocated 1:1 into
patients to treatments modified Valsalva group (treatment), and
randomized? standard Valsalva group (control).
Were the groups similar at Unclear It was not mentioned in the paper.
the start of the trial?
Aside from the allocated Yes. The two groups were treated equally.
treatment, were groups
treated equally?
Were all patients who Yes. There were 238 patients randomized. There was
entered the trial accounted no patient excluded nor loss to follow up so all
for? And were they analyzed patients who entered the trial were accounted for.
in the groups to which they
were randomized?
Were measures objective or Yes The measures were objectives by achieving sinus
were the patients and rhythm with 12 lead ECG
clinicians kept “blind” to
which treatment was being
received?
How large was the treatment After 60s, 19/119 (16%) achieved sinus rhythm with
effect? Standard Valsalva maneuver and 55/119 (46%) with
Modified Valsalva maneuver. RR 2.89 with 95% CI,
1.8357-4.5648 (p<0.0001). The number needed to treat
(NNT) was 3.306
How precise was the The relative risk between the two groups were 2.89 with
estimate of the treatment 95% CI, 1.8357-4.5648 (p<0.0001).
effect?
Is my patient so different to No. It can be applied.
those in the study that the
results cannot apply?
Is the treatment feasible in Yes. It is feasible.
my setting?
Will the potential benefits of Yes. The potential benefit of the treatment (the
treatment outweigh the percentage of convert in 60 s is higher in
potential harms of treatment Modified Valsalva than in Standard Valsalva)
for my patients? outweigh the potential harms (no serious adverse
events were reported).
Table 4. Critical Appraisal of Cobacioglu, S et al study12
Is this Randomized Controlled Trial valid?
Corbacioglu, S et al3
Was the assignment of Yes All participants were randomly assigned (1:1) to
patients to treatments Standard Valsalva Maneuver (SVM) or Modified
randomized? Valsalva Maneuver (MVM) as the first treatment
by using opaque-sealed envelopes, that had been
prepared before by the researcher.
Were the groups similar at Yes The demographic characteristic between groups
the start of the trial? were similar
Aside from the allocated Yes The groups were treated equally
treatment, were groups
treated equally?
Were all patients who Yes From 103 patients presented to ED, 47 were
entered the trial accounted excluded and 56 entered the trial accounted for
for? And were they analyzed and there is no loss to follow-up patients
in the groups to which they
were randomized?
Were measures objective or Yes The measures were objective by converting to
were the patients and sinus rhythm recorded by 12-lead ECG
clinicians kept “blind” to
which treatment was being
received?
How large was the treatment Within 3 cycles of maneuver or 1 minute, 3/28 patients
effect? achieving sinus rhythm with Standard Valsalva (10.7%) and
12/28 patients with Modified Valsalva (42,9%). The
relative risk was 4 with 95% CI, 1.2645-12.6535
(p=0.0183). Absolute risk reduction (ARR) was 0.32
(32%). The absolute benefit of treatment is 32% increase in
the conversion rate. The number needed to treat (NNT) was
3.111
How precise was the The modified Valsalva showed RR 4 (95% CI, 1.2645-
estimate of the treatment 12.6535).
effect?
Is my patient so different to No It can be applied to our patient
those in the study that the
results cannot apply?
Is the treatment feasible in Yes It is feasible.
my setting?
Will the potential benefits of Yes The potential benefit is higher than the harm.
treatment outweigh the Mild adverse event had been observed such as
potential harms of treatment dyspnea in 1 patient during the maneuver and
 for my patients? dizziness in 1 patient also.

Table 5. Critical Appraisal of Ceylan, E et al6 study

Is this Randomized Controlled Trial valid?
Ceylan, E et al4
Was the assignment of
patients to treatments
randomized?
Were the groups similar at
the start of the trial?
Aside from the allocated
treatment, were groups
treated equally?
Were all patients who
entered the trial accounted
for? And were they analyzed
in the groups to which they
were randomized?
Were measures objective or Yes
were the patients and
clinicians kept “blind” to
which treatment was being
received?
How large was the treatment Within 1 minute of duration, 4/33 patients achieving sinus
effect?
How precise was the
estimate of the treatment
effect?
Is my patient so different to No.
those in the study that the
results cannot apply?
Is the treatment feasible in
my setting?
Will the potential benefits of Yes.
treatment outweigh the
potential harms of treatment
Yes. All participants were randomized using block
randomization with a block size of 12
No The patients who undergoes Modified Valsalva
maneuver had younger age (50) than the overall
(60) and significant statistically (P=0.007)
Yes. The groups were treated equally
Yes. Totals of 98 patients who entered the trial were
accounted for. The patients were divided into 3
groups Standard Valsalva maneuver, Modified
Valsalva maneuver, and carotid sinus massage.
There were no drop outs in all of the groups.
The measures were objective by converting to
sinus rhythm recorded by 12-lead ECG
rhythm with Standard Valsalva (12%) and 12/32 patients
with Modified Valsalva (37.5%). The relative risk between
the two groups was 3,0938 with 95% CI, 1.1136-8.5950
(p=0.0303). Absolute risk reduction (ARR) was 25.3%. The
absolute benefit of treatment is 25.3% increase in the
conversion rate. The number needed to treat (NNT) was
3.940
The modified Valsalva showed RR 3.0938 (95% CI,
1.1136-8.5950).
It can be applied.
Yes. It is feasible.
The potential benefit is higher than the harm. No
major adverse effects had been reported.
 for my patients?

Primary and Secondary Outcome of the studies

The primary outcome of the four studies were the number of patients converted into sinus
rhythm 1 minute after Valsalva Maneuver.6,10-12 REVERT trial was the first randomized
controlled trial study to evaluate the impact of Modified Valsalva Maneuver. The conversion to
sinus rhythm of Modified Valsalva Maneuver was found to be superior than Standard Valsalva
Maneuver (43% vs 17%). The REVERT study also had 214 patients which relatively large and
the results were statistically significant (95% CI 2.3-5.8; p<0.0001). 10 Chen, C et al study also
found the similar result with REVERT trial, which showed that the number of patients converted
to sinus rhythm after Modified Valsalva was higher than Standard Valsalva 46% vs 16%.
Compared to REVERT trial, this study 119 patients and statistically significant (95% CI 2.5-5.9;
p<0,00001).11

Corbacioglu, S et al randomized controlled trial study was the second to be published and the
result was aligned with the other studies which showed the superiority of Modified Valsalva in
converting patients with SVT to sinus rhythm compared with Standard Valsalva (42.9% vs
10.7%). The number of patients included were 28 patients, the smallest compared to the other
three studies though statistically significant (95% CI, 1.2645-12.6535; p=0,0183).12 Ceylan et al
study found that the Modified Valsalva had shown a statistically significant number of
conversions compared to Standard Valsalva in their 98 participants with 37.5% vs 12.1% (95%
CI, 1.1136-8.5950;p=0.0303).6

The secondary outcomes of REVERT trial were the use of any emergency treatment for
supraventricular tachycardia (including adenosine), the need and reason for admission to
hospital, the length of time participants spent in the emergency department and adverse events.
Adenosine were given more in Standard VM (69%) compared to Modified VM (50%) with
significant p value (p=0.0002). Patients given Standard VM tend to have emergency anti-
arrhythmic treatment (80%) compared to Modified VM (50%) with a significant p value
(p<0.0001). The difference in time in emergency department, adverse event recorded, and
discharged home from emergency department between Modified VM and Standard VM were not
statistically significant. There was no serious adverse event recorded, but there was more adverse
event recorded in Modified VM (6%) than Standard VM (4%) although it was also statistically
not significant (p=0.32). The adverse events in Modified Valsalva maneuver that were recorded
such as increased heart rate, hypotension or light-headedness, nausea, Electrocardiograph
captured events, and musculoskeletal pain.10

The secondary outcomes of Chen, C et al were the use of medication, adverse events, time in
emergency department. Align with the secondary outcome from REVERT trial Chen, C et al also
found the use of medication was higher in Standard Valsalva (71%) compared to Modified
Valsalva (45%), there was no serious adverse event, the adverse event in Modified Valsalva
(1.6%) was higher than Standard Valsalva (0.8%), and the time in emergency department for
patients with Modified Valsalva (2.79 h) was shorter than patients with Standard Valsalva (2.88
h). In addition, Chen, C et al analyse further that divide supraventricular tachycardia into two
subgroups, long RP interval and short RP interval. In the study, valsalva maneuver was more
effective in patients with short RP interval.11

Corbacioglu, S et al included the use of any rescue treatment for SVT and any adverse events as
the secondary outcome of the study. Align with REVERT trial and Chen, C et al, the use of
rescue treatment was higher in patients with Standard Valsalva Maneuver (89.3%) than Modified
Valsalva Maneuver (57.1%) and the Adenosine was given more to patients with Standard
Valsalva (30.4%) than Modified Valsalva (19.6%). However, Corbacioglu, S et al found the
same percentage of adverse event (2%) in both groups. 3 Ceylan et al determined conversion to
sinus rhythm after the intervention and five minutes after the intervention as the secondary
outcome. There was no serious adverse event reported in this study, even though it was not
included as the secondary outcome of the study.12
DISCUSSION
Valsalva maneuver is a maneuver attempting forceful exhalation against a closed airway. There
are four phases occurring in Valsalva Maneuver. The first phase begins with the onset of
straining, which will increase the intrathoracic pressure resulting in higher pressure in the aorta
and pulmonary vessels. The increasing pressure in pulmonary vessels lead to increase blood flow
to the left atrium, hence increase blood flow to the left ventricle. Increase in stroke volume and
aortic resistance resulted to more than 15 mmHg blood pressure increase. The second phase
happens when there is a decrease in vein blood returning to the heart which causes a decrease in
stroke volume. The decrease in stroke volume affect the lowering of blood pressure which is
detected by the baroreceptors. Baroreceptors will then activate sympathetic nervous system to
increase the vascular resistance and increase the heart rate (relative tachycardia may happen
during this phase). The third phase is the opposite of the first phase, it began instantaneously
when the patient breath in. The sudden decrease in the intrathoracic pressure causes less
resistance to aorta and pulmonary vessels which causes less blood to flow into the heart. Less
blood flow into the heart causes less stroke volume and there will be a drop of blood pressure.
The last phase begins after left ventricle filling is increase due to low resistance in pulmonary
vessels. The sudden increase in stroke volume will increase the blood pressure and baroreceptors
will react via parasympathetic nervous system stimulating the vagal tone and decreasing heart
rates.13

Conversion to sinus rhythm was achieved in patients with AVNRT during the first phase or the
last phase of valsalva maneuver where parasympatic mechanism was dominant. Atrial-His
Bundle interval will be increased until 30ms, so the impulse will fall into the refractory period
terminating the tachycardia responses.13 However, additional effect on slowing the
atrioventricular node conduction can be achieved with a postural modification of Standard
Valsalva by raising legs. This modification, known as Modified Valsalva Maneuver. This
induces more venous return to the heart on the last phase of valsalva maneuver and stimulates
more stimulus in vagal tone.13-16

Modified Valsalva showed its superiority to Standard Valsalva Maneuver in converting patients
with SVT to sinus rhythm based on the primary outcome of four randomized controlled trial
included in this study. The percentage of patients converted to sinus rhythm 1 minute after
Modified Valsalva ranging from 37.5% to 46%, while for the patients after Standard Valsalva the
percentage ranging from 10.7% to 17% or in other words, Modified Valsalva is approximately
three times more effective than Standard Valsalva.6,10-12

The superiority of Modified Valsalva was also supported by the secondary outcomes from the
three RCTs.10-12 The higher percentage of patients converted to sinus rhythm 1 minute after
Modified Valsalva meant there were more patients converted earlier. Thus, it was aligned with
the principle of treating hemodynamically stable SVT to convert the patients as early as possible
to sinus rhythm and as a result, will lower the use of additional anti-arrhythmic treatment, lower
the adenosine use, and reduce the time spent in the ED.10-12,14

The adverse event found in two RCTs were higher in patients with Modified Valsalva. The
adverse events found were increased heart rate, hypotension or light-headedness, nausea,
musculoskeletal pain, electrocardiograph captured events, transient headache, shortness of
breath, and cyanosis.10,11 However, there was no serious adverse event reported in both Standard
Valsalva and Modified Valsalva Maneuver in the four RCTs, which both maneuvers can be
considered safe.6,10-12 In addition, the maneuver had been stated to be safe in patients with
atherosclerosis in carotid artery.9

Evaluating the patients is crucial and if the maneuver is not successful, further treatment need to
be given to the patient following the guideline. All the four RCTs followed a strict procedure in
which if the patients were not converted to sinus rhythm after 3 Valsalva Maneuver, Adenosine
or additional anti-arrhythmic treatment should be given.6,10-12 Immediate synchronized
cardioversion should be administered as quickly as possible to patients unaffected by Adenosine
or additional anti-arrhythmic treatment and hemodynamically unstable SVT patients.5

Modified Valsalva Maneuver for hemodynamically stable SVT patients, with no additional cost,
is safe and more than twice as effective as Standard Valsalva Maneuver. 4,6,9-11,15 It can be
implemented in emergency department settings and can be taught to patients. A research
conducted by Walker, S et al concluded that many doctors failed to correctly instruct patients
how to perform the most effective Valsalva Maneuver so that it is important to educate the
patients correctly and effectively so that the beneficial impact may be achieved. 4 As long as
individuals can safely perform Modified Valsalva Maneuver, it can be used as a routine initial
treatment for episodes of SVT.10 The implementation of this modification can reduce the use of
additional anti-arrhythmic treatments (including Adenosine), presentations to hospital and drug
cost.4,6,10-12,15
Abbreviations
ACC : American College of Cardiology
AHA : American Heart Association
ARR : absolute risk reduction
AV : atrioventricular
AVNRT : atrioventricular-nodal reentrant tachycardia
CEBM : Centre for Evidence-Based Medicine
CI : confidence interval
ECG : electrocardiogram
ED : emergency department
ER : emergency room
HRS : Heart Rhythm Society
NNT : number needed to treat
RCT : randomized controlled trial
REVERT : randomized evaluation of modified Valsalva effectiveness in re-entrant
tachycardias
SVT : supraventricular tachycardia
VM : Valsalva maneuver

Sources of Funding
None related to this manuscript.

Conflict of Interest
None related to this manuscript.

Acknowledgments
The authors thank all who support this evidence-based case report.

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